List of Abbreviations
(A), or (B), (C), (D) – strength of recommendations A (B, C, D respectively)
BP – blood pressure
ALT – alanine aminotransferase
AST – aspartate aminotransferase
HIV – human immunodeficiency virus
TEOAE – transient evoked otoacoustic emissions
WHO – World Health Organization
CHD – congenital heart disease
ABR – auditory brainstem responses
NEC – necrotizing enterocolitis
SBP – systolic blood pressure
NCPAP – nasal continuous positive airway pressure
CRP – C-reactive protein
US – ultrasound examination
CRH – central regional hospital
ECG – electrocardiography
EchoCG – echocardiography
Terms and Definitions
Basic newborn care – the minimum set of medical interventions that must be provided to a newborn infant in a hospital.
Live-born infant – a newborn delivered at a gestational age of 22 weeks or more with a birth weight of 500 grams or more (or less than 500 grams in multiple births) or in case of unknown birth weight, with a body length of 25 cm or more, showing signs of live birth (respiration, heartbeat, umbilical cord pulsation, or voluntary muscle movement).
Audiological screening – hearing assessment in a newborn using evoked otoacoustic emissions or automated auditory brainstem response testing.
Neonatal screening – mass screening of newborns for hereditary diseases, for which obstetric healthcare organizations perform blood sampling followed by sending the samples to authorized organizations for laboratory testing.
Screening for congenital heart defects – screening for critical congenital heart defects in newborns for the purpose of their early detection.
International growth standards scale – an scale for assessing anthropometric parameters (standardized growth and development indicators developed based on the international multicenter Intergrowth-21st project).
1. Brief information on the disease or condition
1.1 Definition of the disease or condition
Healthy newborn – a term infant born in a satisfactory condition, with no diseases and pathological conditions.
1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)
Not applicable
1.3 Epidemiology of the Disease or Condition
According to the Federal State Statistics Service (Rosstat) for 2022, the number of children born sick or who fell ill in the neonatal period is 31.5% (398,000 children) of the total number of live births. Accordingly, 68.5% (906,087 children) of live births were born healthy [1].
1.4 Features of Coding the Disease or Condition
Z37.0 Single liveborn infant
Z37.2 Twins, both liveborn
Z37.5 Other multiple births, all liveborn
Z38.0 Single liveborn infant, born in hospital
Z38.3 Twins, born in hospital
Z38.6 Other multiple births, born in hospital
Z00.1 Routine child health examination
1.5 Classification of the disease or condition
Not applicable
1.6 Clinical presentation of the disease or condition
Not applicable
2. Diagnostics, medical indications and contraindications for diagnostic methods
Criteria for establishing the diagnosis/condition:
The diagnosis of "Healthy newborn" is established for a child
- with spontaneous breathing within 30 seconds after birth, heart rate greater than 100 beats per minute,
- based on physical examination findings in the absence of visible malformations,
- in the absence of abnormalities according to clinical, laboratory, and instrumental examinations,
- not requiring additional medical care associated with changes in the newborn's condition in the maternity hospital,
- if no other diagnosis has been established during observation and examination in the maternity hospital.
2.1 Complaints and Anamnesis
To identify risk factors for the development of pathological conditions in the newborn, it is recommended to review the maternal history and the course of labor [2–5].
Level of Evidence BLevel of Confidence 2Level of recommendation B (level of evidence – 2).
2.2 Physical Examination
To assess the condition of the newborn infant, determine the need for resuscitation measures, and rule out visible congenital malformations, it is recommended to perform a physical examination and evaluate the newborn's condition using the Apgar score at 1 and 5 minutes of life [6–11].
GPP CLOE 4Grade of Recommendation C (Level of Evidence – 4).
Comments: It is necessary to assess the child's condition and determine whether resuscitation measures are needed. In the absence of indications for resuscitation, the infant is handed over to the mother and put to the breast. All procedures (weighing the newborn, measuring head circumference, determining body length, treating the umbilical cord stump) in healthy children should be performed after the first breastfeeding, once the infant receives the first drops of colostrum.
The condition of the newborn infant is assessed at 1 minute and 5 minutes after birth using the Apgar score. Spontaneous respiration, heartbeat, skin color, newborn reflexes, and muscle tone are evaluated. (Appendix G1).
Upper airway clearance, gastric probing, and assessment of rectal patency with a probe are performed only when indicated, including suspected malformations and/or prenatally detected malformations. Deep and aggressive pharyngeal stimulation can cause arrhythmia, laryngospasm, bronchospasm, and apnea in the newborn.
Examination of a healthy infant reveals the following signs: (examination time (hours and minutes)).
Child's condition: satisfactory,
Description of the newborn's appearance (Habitus), absence of visible malformations.
Anthropometric measurements: Reference values for parameters of a healthy term newborn: body weight (2300 - 4100 grams), body length (45 - 53 cm), head circumference (31 - 36 cm) according to the centile charts of international growth standards (Appendix A3).
Newborn neurological status:
Reaction to examination: adequate – appropriate for gestational age.
Level of spontaneous motor activity: appropriate for gestational age, movements are symmetrical, all limbs are involved in movements.
Character of the newborn's cry: loud, emotional.
Posture: physiological flexor or fetal.
Muscle tone: satisfactory, symmetrical.
Physiological reflexes of the newborn (oral and spinal automatism): Moro reflex, upper and lower grasp reflexes, rooting and sucking reflexes, automatic stepping, Babinski reflex, Babkin reflex, Bauer crawling reflex.
Pathological neurological symptoms are absent.
Osteoarticular system. No abnormalities
Skin, subcutaneous adipose tissue, visible mucous membranes. No abnormalities
Chest: shape correct, symmetrical. Chest percussion – determination of cardiac dullness borders, assessment of percussion sound over the lung surface – no abnormalities.
Respiratory system: Respiratory rate within 30 - 60 breaths per minute, rhythmic. Percussion over the lungs – pulmonary sound. Auscultation over the lungs – puerile breathing, transmitted evenly to all areas, no rales auscultated.
Cardiovascular system: Regular rhythm. HR on average at rest from 110 to 160 beats per minute. Heart sounds loud, clear. No murmurs, no accentuation.
Abdomen and digestive organs: Abdomen of normal shape, soft. Liver +1 cm / not palpable, spleen not enlarged.
Examination of the umbilical cord remnant or umbilical wound: Umbilical cord remnant unremarkable.
Genitourinary system: External genitalia correctly formed, female type: labia majora cover labia minora / male type: testes descended into the scrotum.
Anorectal region: Anus formed, no fistulous openings. Stool: meconium / none [12].
To determine the anthropometric data of a newborn infant, it is recommended to measure body weight, determine body length, and measure head circumference. Anthropometric assessment is performed by a neonatologist based on the centile charts of international growth standards [13–15].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
Comments: The first measurement of the child's anthropometric data should be performed in the delivery room. Centile charts of international growth standards are in Appendix A3.
2.3 Laboratory Diagnostics
In the presence of clinical indications established by a neonatologist, it is recommended that the newborn in the postnatal ward undergo selective determination of main ABO blood groups, Rhesus antigen D (Rh factor) testing, direct antiglobulin test (direct Coombs test), total blood bilirubin level testing, and unconjugated and conjugated blood bilirubin level testing [16–22].
GPP CLOE 4Grade of Recommendation C (Level of Evidence – 4).
Comment: In the delivery suite, when indicated, the newborn's main ABO blood groups are determined by a rapid test using monoclonal antibodies (Anti-A and Anti-B blood grouping reagents).
The result is recorded on the title page of the newborn development history and signed by the neonatologist who performed the assessment. The mother is informed of the examination results with comments regarding preliminary blood group information, as the determination was performed using a rapid test.
Laboratory determination of main ABO blood groups, Rhesus antigen D (Rh factor) testing, direct antiglobulin test (direct Coombs test), total blood bilirubin level testing, and unconjugated and conjugated blood bilirubin level testing are performed only in infants at risk for hemolytic disease of the newborn.
For the purpose of early detection, timely treatment, prevention of disability and severe clinical consequences, as well as reduction of mortality from congenital and hereditary diseases, it is recommended that the newborn infant undergo neonatal screening for congenital and (or) hereditary diseases and expanded neonatal screening for congenital and (or) hereditary diseases[1] [23,24].
GCR BLOE 2Grade of Recommendation B (Level of Evidence – 2).
Comment: Neonatal screening for congenital and (or) hereditary diseases and expanded neonatal screening for congenital and (or) hereditary diseases are carried out only after obtaining the informed voluntary consent of the patient's parents or legal representatives to medical intervention.
To perform neonatal screening for congenital and (or) hereditary diseases and expanded neonatal screening for congenital and (or) hereditary diseases, blood samples are collected from the newborn's heel 3 hours after feeding, at the age of 24–48 hours of life in a full-term newborn and on the 7th day (144–168 hours) of life in a preterm newborn.
Blood samples are collected on 2 filter paper test cards issued by the medical genetic counseling center. The analysis of blood samples is carried out in the medical genetic counseling center within up to 10 days after blood sample collection. The blood collection for neonatal screening is recorded by the neonatologist in the newborn's developmental history and the discharge summary.
In the presence of clinical indications determined by the neonatologist, it is recommended that the newborn undergo selective complete blood count in the postpartum ward [25–27].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
[1] Order of the Russian Ministry of Health No. 274n dated April 21, 2022, "On Approval of the Procedure for Providing Medical Care to Patients with Congenital and (or) Hereditary Diseases"
2.4 Instrumental Diagnostics
For the purpose of early detection of congenital hearing loss, as well as prevention of severe disability, it is recommended that the newborn undergo a hearing test using otoacoustic emissions or auditory brainstem response testing [28,29].
GCR BLOE 2Grade of Recommendation B (Level of Evidence – 2).
Comment: hearing testing using evoked otoacoustic emissions or auditory brainstem responses is carried out after obtaining the voluntary informed consent of the patient's parents or legal representatives to medical intervention.
In the maternity hospital, the test is performed in all newborns at the age of 3–4 days by recording evoked otoacoustic emissions (EOAE). Children at risk for hearing loss, as well as children classified into this risk group based on the test results, are referred to an audiology center at the age of up to 3 months for additional testing using EOAE and auditory brainstem response (ABR) testing.
The test is performed by medical personnel of obstetric care facilities who have undergone thematic advanced training. After the test is performed, the result is entered into the newborn's developmental history (medical record) and the discharge summary. If the newborn's documentation lacks a record of the performed test upon admission for follow-up at the local children's polyclinic, this test is performed at the children's polyclinic.[2]
For the purpose of early detection of the risk of critical and cyanotic congenital heart defects (CHD) not detected during prenatal screening, it is recommended that the newborn undergo a set of examinations for the diagnosis of congenital heart defects [30–32].
GPP ALOE 1Grade of Recommendation A (Level of Evidence – 1).
Comment: The set of examinations for the diagnosis of CHD includes assessing the color of the skin and mucous membranes, as well as determining pre- and postductal (on the right arm and any leg): peripheral pulses, pulse oximetry and, if necessary (when weak peripheral pulses are detected), systolic blood pressure (SBP).
CHD screening is performed at 36–48 hours of newborn life subject to a number of conditions: the infant must be fed and warm, in a state of quiet wakefulness or sleep; when using a single monitor, pulse oximetry and blood pressure measurements on the right arm and leg should be performed as close together in time as possible. Pulse oximetry and peripheral blood pressure measurement are performed by the indirect oscillometric method. Disposable cuffs are used to measure blood pressure (pediatric: 3.3–5.6 cm; 4.2–7.1 cm; 5.4–9.1 cm; 6.9–11.7 cm). The cuff width must cover at least two-thirds of the length of the right upper arm or thigh and encompass the entire circumference of the arm or leg. If simultaneous pre- and postductal measurement is not possible, blood pressure and pulse oximetry are measured sequentially with short time intervals (no more than 1–2 minutes); if the newborn's activity state changes during measurements (sleep-wakefulness, wakefulness-crying), the measurement must be repeated 5 minutes after a state of quiet is achieved.
Interpretation of results: after determining the color of the skin and mucous membranes, assessing peripheral pulses, and evaluating the difference between pre- and postductal pulse oximetry, the primary CHD screening is considered "passed" if: satisfactory peripheral pulses are determined, symmetrical on the right brachial and femoral arteries; a pink color of the skin and visible mucous membranes is visualized; pre- and postductal pulse oximetry is 95% or more, and the difference between pre- and postductal saturation levels is less than 3%. If the primary CHD screening is "passed", the infant may be discharged home with the note "screening for critical CHD passed" in the medical record. If the primary CHD screening is "failed", expanded CHD screening is indicated: triple hourly pre- and postductal pulse oximetry and SBP measurement, assessment of pre- and postductal peripheral pulses, skin and mucous membrane color, and evaluation of urine output rate. Expanded CHD screening is considered "passed" if:
- satisfactory peripheral pulses are determined, symmetrical on the right brachial and femoral arteries; a pink color of the skin and visible mucous membranes is visualized; adequate urine output rates are present;
- pre- and postductal pulse oximetry is 95% or more, the difference between pre- and postductal pulse oximetry is less than 3% over time; the difference between pre- and postductal SBP levels is 10 mm Hg or less.
In the event of a "failed" set of examinations for the diagnosis of congenital heart defects, to rule out critical CHD, the newborn must be prescribed an additional test – echocardiography [31,33]. The procedure for neonatal screening for critical and cyanotic CHD is presented in Appendix B.
If there are indications determined by the neonatologist, taking into account the diagnostic capabilities of the medical institution, to rule out organic pathology, it is recommended that the newborn selectively undergo neurosonography, echocardiography, comprehensive abdominal ultrasound, ultrasound of the kidneys and adrenal glands, and hip ultrasound in the postpartum ward [34–38].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
[2] Letter of the Ministry of Health and Social Development of Russia No. 2383-RK dated April 1, 2008
2.5 Other Procedures
Not applicable.
3. Treatment, including drug and non-drug therapies, diet therapy, and pain management
3.1. Conservative management
To prevent infectious eye diseases in the newborn, the use of erythromycin eye ointment is recommended [39–41].
GCR ALEL 1Grade of Recommendations A (Level of Evidence – 1)
Comments: After wiping each eyelid, an erythromycin-containing eye ointment (in single-dose packaging) is placed into each lower conjunctival sac as a 0.5 - 1 cm long strip. The drug should be applied with gentle eyelid massage, and the excess ointment can be wiped off after one minute.
To prevent the development of hemorrhagic disease, the administration of vitamin K (ATC code B02BA) in the first hours after birth is recommended for the newborn [42–44].
Level of Evidence AGrade of Evidence 2Level of Recommendations A (Grade of Evidence – 2)
Comments: The vitamin K group (ATC code B02BA) includes the drug phytomenadione. Phytomenadione (ATC code B02BA01) is administered at a dose of 1 mg intramuscularly in newborns of at least 36 weeks, 1 mg intramuscularly or intravenously in preterm infants of less than 36 weeks and with a body weight of at least 2500 g; in preterm infants of less than 36 weeks and with a body weight of less than 2500 g, the drug is administered at a dose of 0.4 mg/kg intramuscularly or intravenously. Contraindications: hypersensitivity to phytomenadione (ATC code B02BA01) and other components of the drug. Use with caution in suspected glucose-6-phosphate dehydrogenase deficiency. The drug action begins 30 minutes after administration.
In the absence of phytomenadione (ATX code B02BA01) 1% emulsion, administration of menadione sodium bisulfite** (ATX code B02BA02) 1% solution is possible. It should be noted that its effect begins 8-24 hours after administration. Menadione sodium bisulfite** (ATX code B02BA02) is administered via intramuscular drug injection. The daily dose of the drug is: for newborns – 1-1.5 mg/kg/day (0.1-0.15 ml/kg/day), but not more than 4 mg/day; for children under 1 year – 2-5 mg/day. Frequency of administration – from 1 to 2-3 times a day. Contraindications: hypercoagulation, thromboembolism, hemolytic disease of the newborn. Use with caution in glucose-6-phosphate dehydrogenase deficiency.
Administration of vitamin K (ATX code B02BA) is carried out after obtaining written consent from the mother and/or the patient's legal representative.
To prevent the development of severe forms of tuberculosis and its complications, a newborn infant is recommended to receive the tuberculosis vaccine** (ATX code J07AN) in the absence of contraindications and with the consent of a parent or legal representative [45–48].
Level of Evidence AGrade of Evidence 2Level of Recommendations A (Grade of Evidence – 2)
Comment: Newborns are vaccinated against tuberculosis in accordance with Order No. 1122n of the Russian Ministry of Health dated December 6, 2021, "On Approval of the National Schedule of Preventive Vaccinations, the Schedule of Preventive Vaccinations by Epidemiological Indications, and the Procedure for Conducting Preventive Vaccinations"[3]. Vaccination of newborns is carried out in medical organizations licensed to carry out medical activities that include neonatology work (service) after informed consent from the parents or legal representatives of the newborn.
Specific tuberculosis prophylaxis is permitted using only medicinal products registered in the Russian Federation.
No other parenteral manipulations, including neonatal screening, are performed on the infant on the day of vaccination! Due to early discharge from obstetric inpatient facilities and in the absence of contraindications, tuberculosis vaccination for newborns can be performed starting from the third day of life; discharge is possible on the same day after vaccination if there is no reaction to it.
The tuberculosis vaccine** (ATX code J07AN) is administered strictly intradermally at the border of the upper and middle thirds of the outer surface of the left arm after prior skin preparation with 70% ethanol** (ATX code D08AX08). With proper administration technique, a whitish papule with a diameter of at least 7 - 9 mm should form, usually disappearing within 15 - 20 minutes. Subcutaneous administration of the drug is unacceptable, as it may cause a cold abscess.
The neonatologist informs the parents that 4 - 6 weeks after intradermal vaccination, the child should develop a local vaccination reaction, and if it appears, the child must be shown to the district pediatrician. It is strictly forbidden to treat the reaction site with any solutions or apply various ointments.[4]
To prevent viral hepatitis B infection, a newborn infant is recommended to receive the hepatitis B vaccine** (ATX code J07BC01) in the absence of contraindications and with the consent of the parents or legal representative [49,50].
GRC BLEL 2Grade of Recommendation B (Level of Evidence – 2)
Comment: Hepatitis B vaccination has proven its efficacy in preventing hepatocellular carcinoma, cirrhosis, and chronic liver diseases associated with hepatitis B. Hepatitis B vaccination is carried out according to the 0, 1, 6-month schedule. The first administration of the hepatitis B vaccine** (ATX code J07BC01) is carried out for all newborns in the first 24 hours of the child's life. Newborns born to mothers who are hepatitis B virus carriers represent a risk group for hepatitis B virus infection. To immunize newborns born to virus-carrier and hepatitis B-positive mothers, a different vaccination schedule must be used: 0, 1, 2, and 12 months of the child's life.[5] To increase prophylactic efficacy in individuals at particularly high risk, active-passive immunization is performed – the simultaneous use of the hepatitis B vaccine** (ATX code J07BC01) and human hepatitis B immunoglobulin (ATX code J06BB04), which contains a high titer of antibodies to HBsAg. Active-passive immunization in the maternity hospital is indicated for newborns born to mothers:
- with acute viral hepatitis B;
- early convalescents of hepatitis B;
- with the presence of HBsAg in the blood.
Hepatitis B vaccine** (ATC code J07BC01) is administered 2 hours after the administration of human hepatitis B immunoglobulin (ATC code J06BB04) [6,49,51].
3.2. Surgical treatment
Not applicable
3.3. Other treatment
To ensure successful breastfeeding and reduce neonatal morbidity and mortality, early initiation of breastfeeding (recommended within the first hour after birth) is advised [6,52–55].
GRC BLEL 2Grade of Recommendation B (Level of Evidence – 2)
Comments: A newborn infant who does not require resuscitation measures after birth should be placed on the mother's abdomen or chest, ensuring skin-to-skin contact with an unclipped umbilical cord. Healthy infants who experience skin-to-skin contact are more likely to be breastfed and for longer periods. Earliest possible initiation of breastfeeding is necessary for all newborns, including stable preterm or low-birth-weight infants who are capable of receiving breast milk. The first breastfeeding should be performed within the first hour after birth regardless of the mode of delivery. Most newborns are ready for feeding as early as 15 minutes after birth. The duration of suckling for healthy term newborns should not be restricted. To ensure successful latching and full lactation, the newborn infant must room-in with the mother in the same ward. All procedures (body weight measurement, head, shoulder, and chest circumference measurements, umbilical stump care) in healthy infants should be performed after the first breastfeeding, once the infant has received the first drops of colostrum. The mother of the child must be supported to initiate breastfeeding. Breast size, shape, and nipple anatomy are individual for each woman and do not affect breast function.
Maternal contraindications to postpartum breastfeeding include: oncological diseases requiring chemotherapy, active pulmonary tuberculosis with sputum bacillary excretion; particularly dangerous infections (smallpox, anthrax); maternal HIV infection; acute phase of maternal mental illness; acute hepatitis B and C in the active phase; use of medications incompatible with breastfeeding based on the mother's health status.
In cases where breastfeeding cannot be initiated due to temporary (relative) contraindications on the part of the mother and/or the child, the mother should be guided to maintain lactation and resume breastfeeding later when the condition of the mother and/or child permits. The presence of a breast implant is not a contraindication to breastfeeding. If the mother is receiving a medication contraindicated during breastfeeding, an attempt should be made to find a compatible alternative drug. In certain infectious diseases (including influenza, chickenpox, SARS-CoV-2, etc.), breastfeeding can be continued while maintaining maternal-infant distancing and all hygiene measures, or feeding with expressed breast milk is possible. If the mother is HBsAg-positive, breastfeeding is possible after active-passive immunization of the newborn [56]. Absolute contraindications for breastfeeding on the part of the child are severe metabolic disorders (galactosemia, phenylketonuria, maple syrup urine disease [branched-chain ketoaciduria]) [56–58].
[3] Order of the Russian Ministry of Health No. 1122n dated December 6, 2021, "On Approval of the National Schedule of Preventive Vaccinations, the Schedule of Preventive Vaccinations by Epidemiological Indications, and the Procedure for Conducting Preventive Vaccinations" as amended by the Order of the Russian Ministry of Health No. 677n dated December 12, 2023 (registered by the Ministry of Justice of the Russian Federation on January 30, 2024, registration No. 77040).
[4] Order of the Russian Ministry of Health No. 109 dated March 21, 2003, "On Improving Antituberculosis Measures in the Russian Federation" (as amended by Orders of the Ministry of Health and Social Development of the RF No. 855 of October 29, 2009, No. 297 of June 5, 2017)
[5] Order of the Ministry of Health of the Russian Federation No. 1122n dated December 6, 2021, "On Approval of the National Schedule of Preventive Vaccinations, the Schedule of Preventive Vaccinations by Epidemic Indications, and the Procedure for Conducting Preventive Vaccinations" as amended by Order of the Ministry of Health of the Russian Federation No. 677n dated December 12, 2023 (registered with the Ministry of Justice of the Russian Federation on January 30, 2024, registration No. 77040).
4. Medical Rehabilitation and Sanatorium-Resort Treatment
Not applicable
5. Prevention and Dispensary Observation
Prevention
To prevent anemia and improve long-term neurological outcomes in the newborn, it is recommended to perform delayed cord clamping and cutting after 60–120 seconds, provided there is no need for immediate resuscitation of the mother or infant [59–65].
GCR ALEL 1Grade of Recommendations A (Level of Evidence – 1)
Comments: Early cord clamping (immediately after birth) may lead to a decrease in hemoglobin levels and the development of early anemia.
Too late cord clamping leads to hypervolemia and polycythemia, which can cause clinical deterioration of the newborn, internal organ dysfunction, metabolic disorders, and hyperbilirubinemia, and may require medical interventions aimed at correcting these pathological conditions.
In HIV-positive parturients and patients with unknown HIV status, there is no evidence that delayed cord cutting increases the likelihood of mother-to-child transmission of HIV [5].
Procedure for umbilical cord clamping:
- apply one reusable vascular clamp to the umbilical cord at a distance of 10 cm from the umbilical ring;
- apply a second reusable vascular clamp to the umbilical cord as close as possible to the external genitalia of the parturient;
- apply a third reusable vascular clamp 2 cm outward from the first one; wipe the segment of the umbilical cord between the first and third clamps with a sterile woven gauze wipe (non-woven wipe, cotton ball) moistened with 70% ethanol** (ATC code D08AX08), and cut with sterile scissors. The application of the third clamp will allow cord blood collection if necessary.
Data on the time of cord clamping must be recorded in the newborn's developmental history.
To prevent hypothermia in the newborn, it is recommended to ensure an optimal thermal environment in the delivery room (at least 25 °C), eliminate drafts, turn on the radiant warmer above the neonatal resuscitation table, and warm the receiving tray and blankets for the newborn [6, 66–68].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
Comments: Evaporation from the skin surface leads to a decrease in the newborn's body temperature within the first few seconds after birth. This is an intense sensory stimulus that triggers spontaneous breathing after birth. At this point, heat loss is physiological in nature and cannot be avoided. It is necessary to prevent a further decrease in the newborn's body temperature, since at a body temperature of 36°C and below, hypothermia develops, triggering a cascade of pathological processes leading to adverse consequences.
To prevent infection and accelerate mummification of the newborn's umbilical stump, it is recommended to use dry cord care [69–71].
GCR ALEL 1Grade of Recommendations A (Level of Evidence – 1)
Comments: the umbilical stump dries and mummifies when exposed to air, and then falls off during the first or second week of life. Caring for the umbilical stump does not require sterile conditions. The umbilical cord should not be treated with antiseptics and disinfectants (ATC code D08A) – boric acid + resorcinol + phenol + fuchsin, other antiseptics and disinfectants (ATC code D08AX) – ethanol**, potassium permanganate**, methylthioninium chloride, etc.). If the umbilical stump becomes soiled, it should be washed with water and dried with a clean cloth diaper or woven gauze wipe.
To prevent skin infection, eczema, and to protect the skin, it is recommended to provide proper newborn skin care [69, 70].
Level of Evidence AGrade of Evidence 2Level of Recommendations A (Grade of Evidence – 2)
Comments: The baby should be bathed in warm tap water without adding antiseptics, disinfectants (ATC code D08), or herbal infusions. Shampoos, bubble baths, and other cleansers should be used no more than 1–2 times a week. When using disposable diapers, the following rules should be followed: change diapers as they fill, change them immediately after the baby defecates, and arrange air baths throughout the day. Water-based products (creams, lotions, milks) should be used for newborn skin care.
Dispensary follow-up (Active surveillance)
Not applicable
6. Organization of Medical Care
The first examination of the newborn by a neonatologist is performed in the delivery room of an obstetric healthcare facility to assess the general condition of the newborn, determine the need for resuscitation, and detect visible congenital malformations.
Newborns showing no signs of disease are transferred from the delivery rooms (operating rooms) of medical organizations to mother-baby room-in wards or physiological newborn wards for further routine medical care.
Depending on the newborn's condition and the time of transfer to the physiological newborn ward or mother-baby room-in ward, a repeat examination by the on-duty neonatologist is performed either in the delivery room (operating room) of the obstetric facility before transfer, or in the physiological newborn ward, but no later than 2 hours after birth.
During the first 24 hours of life, the newborn is examined by a nurse (male nurse) every 3–3.5 hours to assess their condition and provide medical care if necessary. The examination results are recorded in the newborn's medical documentation.
Daily examination of the newborn is performed at least once a day; in case of clinical deterioration, as often as required by the newborn's condition, but at least once every 6 hours.
Upon discharge of the newborn home, the medical organization prepares the newborn's medical documentation and transmits information about the child's discharge to the primary pediatric healthcare organization at the newborn's actual place of residence to arrange home patronage.
By the time of discharge, the infant must actively suck from the breast and/or bottle through a nipple, tolerate feedings, and maintain a normal body temperature. The maximum weight loss since birth is less than 10% [72, 73]. According to laboratory and supplementary tests performed for clinical indications, there are no pathological changes or only minor deviations from the norm that do not threaten the child's life and health and do not require inpatient monitoring and treatment.
7. Additional Information
Not applicable
Criteria for Evaluating the Quality of Medical Care
№ | Quality criteria | Performance assessment (yes/no) |
1. | A visual therapeutic examination and newborn assessment using the Apgar score were performed. | Yes/no |
2. | Delayed cord clamping and transection were performed after 60–120 seconds if immediate assistance to the mother or child was not required | Yes/no |
3. | Newborn hypothermia prevention was performed. | Yes/no |
4. | Body weight measurement, body length determination, head circumference measurement, and anthropometric data assessment based on international growth standard centile charts were performed. | Yes/no |
5. | Ocular infection prophylaxis with erythromycin eye ointment was performed. | Yes/no |
6. | Vitamin K administration (ATC code B02BA) was performed in the absence of contraindications. | Yes/no |
7. | Vaccination for the prevention of viral hepatitis B was performed in the absence of contraindications. | Yes/no |
8. | Vaccination for the prevention of tuberculosis was performed in the absence of contraindications. | Yes/no |
9. | A set of examinations for detecting critical and cyanotic congenital heart disease (CHD) was performed. | Yes/no |
10. | Hearing screening in the newborn was performed using otoacoustic emissions or automated auditory brainstem response testing. | Yes/no |
11. | Blood sampling was performed for neonatal screening for congenital and/or hereditary disorders and expanded neonatal screening for congenital and/or hereditary disorders. | Yes/no |
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Appendix A1. Working Group Composition
Elena Nikolaevna Baybarina – MD, Professor, Honored Scientist of the Russian Federation, Chief Researcher at the Department of Neonatal and Premature Infant Pathology, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health, Moscow, Russian Federation.
Ekaterina N. Balashova – Candidate of Medical Sciences, Leading Researcher at the Prof. A.G. Antonov ICU of the Institute of Neonatology and Pediatrics, Associate Professor at the Department of Neonatology, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health, Member of the Council of the Russian Society of Neonatologists.
Ekaterina L. Bokeria – Doctor of Medical Sciences, Advisor to the Director, Researcher at the Department of Neonatal and Preterm Infant Pathology No. 2, Institute of Neonatology and Pediatrics, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Ministry of Health of Russia; Professor at the Department of Neonatology, N.F. Filatov Clinical Institute of Children's Health, I.M. Sechenov First Moscow State Medical University of the Ministry of Health of Russia (Sechenov University).
Elena V. Grosheva – Candidate of Medical Sciences, Head of the Department of Neonatal and Preterm Infant Pathology No. 2, Institute of Neonatology and Pediatrics; Associate Professor at the Department of Neonatology, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Ministry of Health of Russia; Member of the Russian Society of Neonatologists.
Dmitry N. Degtyarev – Doctor of Medical Sciences, Professor, Deputy Director for Research, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Ministry of Health of Russia; Head of the Department of Neonatology, Faculty of Pediatrics, I.M. Sechenov First Moscow State Medical University of the Ministry of Health of Russia (Sechenov University); Member of the Council of the Russian Society of Neonatologists.
Viktor V. Zubkov – Doctor of Medical Sciences, Director of the Institute of Neonatology and Pediatrics, Head of the Department of Neonatology, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Ministry of Health of Russia; Professor at the Department of Neonatology, N.F. Filatov Clinical Institute of Children's Health, I.M. Sechenov First Moscow State Medical University of the Ministry of Health of Russia (Sechenov University); Member of the Council of the Russian Society of Neonatologists.
Anna L. Karavaeva – Head of Clinical Work at the Newborn Department No. 1, Institute of Neonatology and Pediatrics, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Ministry of Health of Russia; Higher Category Physician, Member of the Russian Society of Neonatologists.
Mziya I. Makieva – Candidate of Medical Sciences, Head of the Newborn Department No. 2, Institute of Neonatology and Pediatrics, Assistant at the Department of Neonatology, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Ministry of Health of Russia; Associate Professor at the Department of Neonatology, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Ministry of Health of Russia; Higher Category Physician, Member of the Russian Society of Neonatologists.
Irina I. Ryumina – Doctor of Medical Sciences, Professor, Head of the Department of Neonatal and Preterm Infant Pathology No. 1, Institute of Neonatology and Pediatrics, Professor at the Department of Neonatology, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Ministry of Health of Russia; Member of the Russian Association of Perinatal Medicine Specialists, Member of the Russian Society of Neonatologists.
Leila A. Timofeeva – Candidate of Medical Sciences, Head of the Newborn Department No. 1, Institute of Neonatology and Pediatrics, Associate Professor at the Department of Neonatology, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Ministry of Health of Russia; Higher Category Physician, Member of the Russian Society of Neonatologists.
Oksana V. Shumakova – Candidate of Medical Sciences, Neonatologist at the Department of Neonatal and Preterm Infant Pathology No. 2, Institute of Neonatology and Pediatrics, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Ministry of Health of Russia; Assistant at the Department of Neonatology, N.F. Filatov Clinical Institute of Children's Health, I.M. Sechenov First Moscow State Medical University of the Ministry of Health of Russia (Sechenov University).
No conflict of interest.
Appendix A2. Methodology for Developing Clinical Guidelines
Methods used for collecting/selecting evidence: electronic database search.
Description of methods used for collecting/selecting evidence: the evidence base for the recommendations included publications from the Cochrane Library, PubMed, EMBASE, MEDLINE, Scopus, Web of Science, eLIBRARY, ClinicalTrials.gov, electronic libraries, and clinical guidelines published by the National Institute for Health and Care Excellence, the European Association of Perinatal Medicine, the European Society for Pediatric Research, the European Foundation for the Care of Newborn Infants, and the European Society for Neonatology. The search depth covered 69 years.
Methods used for assessing the quality and strength of evidence:
expert consensus;
assessment of significance in accordance with the rating scheme.
Scales for assessing levels of evidence (LE) (Tables 1, 2) for diagnostic, preventive, therapeutic, and rehabilitation methods (diagnostic, preventive, therapeutic, rehabilitation interventions) with definitions, and the scale for assessing grades of recommendation (GR) (Table 3) for preventive, diagnostic, therapeutic, and rehabilitation methods (preventive, diagnostic, therapeutic, rehabilitation interventions).
Methods used for analyzing evidence:
reviews of published meta-analyses;
systematic reviews with evidence tables.
Description of methods used for analysis of evidence.
When selecting publications as potential sources of evidence, the methodology used in each study was reviewed to ensure its validity. Methodological evaluation was based on questions focused on study design features that significantly affect the validity of the results and conclusions.
To minimize potential subjective errors, each study was evaluated independently by at least two members of the working group. Any discrepancies in assessments were discussed by the full working group. If consensus could not be reached, an independent expert was involved.
Economic analysis:
Cost analysis was not performed, and pharmacoeconomic publications were not evaluated.
Method of guidelines validation:
external expert review;
internal expert review.
Description of the guidelines validation method:
The preliminary version of these guidelines was reviewed by independent experts who were asked to comment primarily on whether the interpretation of the evidence underlying the recommendations was accessible and understandable.
Comments were received from primary care physicians and district pediatricians regarding the clarity of the presentation of the guidelines and their assessment of the importance of the guidelines as a working tool in daily practice.
The draft version was also sent to a non-medically trained reviewer to obtain comments from a patient perspective.
Comments received from experts were carefully systematized and discussed by the chair and members of the working group. Each point was discussed, and resulting modifications to the guidelines were recorded. If no changes were made, the reasons for declining the changes were recorded.
Consultation and peer review:
Recent changes to these recommendations are presented for discussion as a preliminary version. The updated version for broad discussion was posted on the website of the Russian Society of Neonatologists (RSN) www.neonatology.pro and the Association of Specialists in Perinatal Medicine, Healthcare Provision for Pregnant Women, Fetuses, Newborns, and Children under 3 Years of Age (ASPM+) www.raspm.ru to provide all interested parties with the opportunity to participate in discussing and improving the recommendations.
The draft guidelines were reviewed by independent experts who were asked to comment primarily on the clarity and accuracy of the interpretation of the evidence base underlying the recommendations.
For the final revision and quality control, the recommendations were re-evaluated by the members of the working group, who concluded that all comments and feedback from the experts had been taken into account and the risk of bias in the development of the recommendations was minimized.
Target audience for these clinical guidelines:
neonatologists
anesthesiologists-resuscitators
pediatricians
obstetricians and gynecologists;
midwives
medical school students;
residents and interns.
Table 1. Levels of Evidence (LoE) grading scale for diagnostic methods (diagnostic interventions)
LoE | Definition |
1 | Systematic reviews of studies with reference standard control or systematic reviews of randomized controlled trials with meta-analysis |
2 | Individual studies with reference standard control or individual randomized controlled trials and systematic reviews of studies of any design, except randomized controlled trials, with meta-analysis |
3 | Studies without consecutive reference standard control or studies with a reference standard not independent of the test method, or non-randomized comparative studies, including cohort studies |
4 | Non-comparative studies, case report |
5 | Only justification of mechanism of action or expert opinion is available |
Table 2. Scale for assessing levels of evidence (LE) for methods of prevention, treatment, and medical rehabilitation, including those based on natural therapeutic factors (preventive, therapeutic, and rehabilitation interventions)
LoE | Definition |
1 | Systematic review of RCTs with meta-analysis |
2 | Individual RCTs and systematic reviews of studies of any design except RCTs, with meta-analysis |
3 | Non-randomized comparative studies, including cohort studies |
4 | Non-comparative studies, case reports or case series, case-control studies |
5 | Only justification of the mechanism of action of the intervention (preclinical studies) or expert opinion is available |
Table 3. Scale for assessing the grades of recommendation (GR) for prevention, diagnostic, treatment, and medical rehabilitation methods, including those based on natural therapeutic factors (preventive, diagnostic, therapeutic, and rehabilitative interventions)
GoR | Definition |
A | Strong recommendation (all considered efficacy criteria (outcomes) are important, all studies are of high or acceptable methodological quality, and their conclusions on the outcomes of interest are consistent) |
B | Conditional recommendation (not all considered efficacy criteria (outcomes) are important, not all studies are of high or acceptable methodological quality, and/or their conclusions on the outcomes of interest are inconsistent) |
C | Weak recommendation (lack of adequate quality evidence (all considered efficacy criteria (outcomes) are unimportant, all studies are of low methodological quality, and their conclusions on the outcomes of interest are inconsistent) |
Procedure for updating clinical guidelines
The mechanism for updating clinical guidelines provides for their systematic revision at least once every three years, as well as upon the emergence of new evidence-based medicine data on the diagnosis, treatment, prevention, and rehabilitation of specific diseases, or in the presence of justified additions/comments to previously approved clinical guidelines, but no more frequently than once every 6 months.
Appendix A3. Reference Materials
These clinical guidelines have been developed taking into account the following regulatory and legal documents:
Federal Law No. 323-FZ "On the Fundamentals of Protecting the Health of Citizens in the Russian Federation" dated November 21, 2011.
Order of the Ministry of Health and Social Development of Russia No. 1687n dated December 27, 2011, "On Medical Criteria of Birth, the Form of the Birth Certificate, and the Procedure for Its Issuance"
Order of the Russian Ministry of Health No. 203n of May 10, 2017, "On Approval of Criteria for Assessing the Quality of Medical Care."
International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10) (World Health Organization), 2019 version.
Order of the Ministry of Health of Russia No. 804n dated October 13, 2017 (as amended on September 24, 2020, with amendments dated October 26, 2022) "On Approval of the Nomenclature of Medical Services" (Registered with the Ministry of Justice of Russia on November 7, 2017, No. 48808).
Methodological Letter "Resuscitation and Stabilization of Newborns in the Delivery Room." Ed. by E.N. Baybarina. Moscow: Ministry of Health of the Russian Federation; 2020.
Rules for the provision of medical care in the specialty "Neonatology" (Order of the Ministry of Health of the Russian Federation No. 921n dated November 15, 2012).
Decree of the Government of the Russian Federation No. 2406-r dated October 12, 2019 (as amended on April 16, 2024) "On Approval of the List of Vital and Essential Medicines, as well as Lists of Medicines for Medical Use and the Minimum Assortment of Medicines Required for Medical Care"
Letter of the Ministry of Health of Russia No. 15-4/10/2-3185 dated May 6, 2014, "On Sending Clinical Recommendations for Medical Care in Uncomplicated Single-Fetus Occipital Deliveries and the Postpartum Period"
Sanitary and Epidemiological Rules and Regulations (SanPiN) No. 3.3686-21 "Sanitary and Epidemiological Requirements for the Prevention of Infectious Diseases" No. 62500 dated January 28, 2021
Order of the Ministry of Health of the Russian Federation No. 1122n dated December 6, 2021, "On Approval of the National Calendar of Preventive Vaccinations, the Calendar of Preventive Vaccinations by Epidemiological Indications, and the Procedure for Conducting Preventive Vaccinations"
Order No. 109 dated March 21, 2003, "On Improving Anti-Tuberculosis Measures in the Russian Federation" (as amended by Orders of the Ministry of Health and Social Development of the Russian Federation No. 855 dated October 29, 2009, and No. 297 dated June 5, 2017)
Order of the Ministry of Health and Social Development of the Russian Federation No. 185 dated March 22, 2006, "On Mass Screening of Newborns for Hereditary Diseases" (including "Regulations on the Organization of Mass Screening of Newborns for Hereditary Diseases," "Recommendations for Blood Sampling during Mass Screening of Newborns for Hereditary Diseases").
Order of the Moscow Healthcare Department No. 935 dated December 26, 2017, "On Amending the Order of the Moscow Healthcare Department No. 183 dated March 12, 2015."
Letter of the Ministry of Health and Social Development of Russia No. 2383-RKh dated April 1, 2008, "On Conducting Universal Audiological Screening in First-Year Infants."
Order of the Ministry of Health of Russia No. 274n dated April 21, 2022, "On Approval of the Procedure for Providing Medical Care to Patients with Congenital and (or) Hereditary Diseases."
State Register of Medicines: https://grls.rosminzdrav.ru
Appendix A3.1 Centile charts of international growth standards (boys)
Appendix A3.2 Centile charts of international growth standards (girls)
Appendix B. Physician Action Algorithms
Procedure for neonatal screening for critical and cyanotic congenital heart defects in infants at 36–48 hours of life.
Appendix C. Patient Information
Basic neonatological care aims to maintain health, assess the risk of neonatal diseases, and provide conditions for successful breastfeeding.
A newborn infant requires special attention from both medical personnel and parents.
Immediately after birth, a healthy newborn infant instinctively begins searching for food; therefore, early initiation of breastfeeding is essential. In the first days after birth, the mother's mammary glands produce colostrum, a thick, yellowish milk. Colostrum contains more protein, antibodies, and other protective factors than mature milk. Given the unique composition of colostrum, it is crucial that the infant receives it from the first hours of life. Mature milk appears within a few days after birth in significantly larger quantities than colostrum. Frequent breastfeeding is necessary to stimulate lactation. There is no need to give supplementary water to a breastfed infant. The frequency and duration of feedings should be determined by the infant's demand. Most infants require nighttime feedings.
For safety reasons, an infant should never be left unattended during care. It is advisable to check the water temperature before bathing and washing the infant, prior to contact with the newborn's skin. The infant should be calmed and rocked smoothly, avoiding sudden arm movements. A newborn should not share a bed with the mother due to the increased risk of falling or accidental suffocation by the mother during sleep. It is recommended that the infant sleep in a separate crib. After discharge home, parents must use child restraint systems (car seats and infant carriers) in vehicles. During evening walks, reflective elements should be used on the stroller and clothing.
During the newborn's stay in the maternity hospital, their condition is closely monitored by all medical personnel. The neonatologist evaluates vital signs. In the first hours of life, the infant requires prophylaxis for hemorrhagic disease of the newborn, which carries a risk of bleeding and hemorrhages. Prophylaxis of hemorrhagic disease of the newborn is performed by intramuscular administration of vitamin K (ATX code B02BA), which is necessary for the synthesis of blood clotting factors and prevents bleeding and hemorrhages.
Vaccination against viral hepatitis B and tuberculosis is performed in the maternity hospital in accordance with the national immunization schedule.
Neonatal screening is performed in the maternity hospital for the early detection of inherited metabolic disorders.
Cardiological screening and, if necessary, echocardiography are performed to rule out congenital heart defects.
Audiological screening is performed to rule out hearing impairment in the newborn infant.
In satisfactory condition, the child is discharged from the hospital on days 3–4 of life under the supervision of a district pediatrician.
Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools
Appendix G1. Apgar scoring of the newborn
Russian title: Newborn assessment by the Apgar score[6]
Original title: The Apgar Score
Source (official developer website, validation publication):
Apgar V, Holaday DA, James LS, Weisbrot IM, Berrien C. Evaluation of the newborn infant-second report. JAMA. 1958; 168 (15): 1985–1988. doi:10.1001/jama.1958.03000150027007 [74]
Type: rating scale
Purpose: assessment of the newborn's condition after birth
Content (template):
Sign | 0 points | 1 point | 2 points |
HR | Absent | Less than 100 beats per minute | 100 or more beats per minute |
Respiration | Absent | Bradypnea, irregular | Active regular, loud cry and crying |
Muscle tone | Limbs hanging limp | Some flexion of limbs, weak movements | Active motion |
Reflex irritability (response to stimulation during upper airway suctioning, sole stimulation) | No response | Grimace | Cough or sneezing |
Skin color | Generalized pallor or generalized cyanosis | Pink body and blue extremities (acrocyanosis) | Entire body and extremities pink |
Key (interpretation): A score of 4–7 points at 1 min after birth corresponds to moderate to mild birth asphyxia (P21.1), and 0–3 points at 1 min after birth corresponds to severe asphyxia (P21.0). Despite the fact that according to ICD-10 a total of 7 points at 1 min after birth corresponds to moderate and mild asphyxia, it is inadvisable to establish this diagnosis, since an Apgar score of 7 points by the end of the 1st minute is not clinically and/or prognostically significant.
[6] Methodological letter "Resuscitation and stabilization of newborns in the delivery room". Ed. by E.N. Baibarina. Moscow: Russian Ministry of Health; 2020.