List of Abbreviations
per os – oral administration / intake
IV – intravenous administration
HIV – human immunodeficiency virus
GA – gestational age
HAI – healthcare-associated infection
CBC – complete blood count
NPUDI – neonatal and premature infant pathology department
NSD – neonatal surgery department
sol. – solution
CRP – C-reactive protein
d. – day
US – ultrasound examination
Terms and Definitions
Omphalitis is an inflammatory process of the base of the umbilical wound, the skin and subcutaneous tissue around the umbilicus, and the umbilical vessels, occurring mainly in the neonatal period [1].
Fungus is a mushroom-like proliferation of granulation tissue during prolonged wound healing.
Funisitis – vasculitis of the umbilical vessels.
1. Brief information on the disease or condition
1.1 Definition of the disease or condition
Omphalitis is an inflammatory process of the base of the umbilical wound, the skin and subcutaneous tissue around the umbilicus, and the umbilical vessels, occurring mainly in the neonatal period [1, 2].
1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)
The umbilical cord connects the fetus to the mother in utero and consists of connective tissue and blood vessels. After birth, it is transected with the formation of the umbilical stump. The necrotic tissue of the umbilical cord is rapidly colonized by bacteria, as it provides a favorable medium for their growth. Thrombosed blood vessels of the umbilical remnant facilitate the penetration of microorganisms into the bloodstream of newborns, which can cause generalization of the infectious and inflammatory process and the development of sepsis [1, 3, 4].
The infection can spread beyond the subcutaneous tissues and affect the fascia (necrotic fasciitis), the musculature of the abdominal wall (myonecrosis), and, when bacteria penetrate the umbilical vessels, the umbilical and portal veins (phlebitis).
Omphalitis is an infection caused by various microbial agents. The most common pathogens are facultative anaerobic microorganisms: Gram-positive bacteria (Staphylococcus aureus, Streptococcus pyogenes) and Gram-negative bacteria such as Escherichia coli, Klebsiella pneumoniae and Proteus mirabilis [1]. Among anaerobes, the largest proportion among causative agents is comprised of such bacteria as Bacteroides fragilis, Clostridium perfringens and Clostridium tetani [3,5–7]. Staphylococcus aureus remains the most frequent causative agent of omphalitis, however, against the background of increasing resistance of opportunistic microflora to systemic antibacterial drugs, the proportion of methicillin-resistant S. aureus (MRSA) strains among omphalitis pathogens has increased [8].
Sometimes omphalitis is the first manifestation of congenital immunodeficiency, for example, leukocyte adhesion deficiency [9–15]. Omphalitis can also be an initial manifestation of neutrophilic disorders in newborns, including neonatal alloimmune neutropenia and congenital neutropenia [16–19].
Causes of the inflammatory process in the umbilical fossa may include congenital developmental anomalies such as patent urachus, patent omphalomesenteric duct, or urachal cyst [20–24].
1.3 Epidemiology of the Disease or Condition
Omphalitis is one of the main forms of healthcare-associated infections (neonatal HAIs). The overall incidence of omphalitis ranges from 0.2% to 0.7% in industrialized countries [25]. In developing countries, the incidence of neonatal omphalitis can reach 22%, as deliveries often take place at home, outside a medical institution [1]. The incidence of omphalitis depends on the method of umbilical cord remnant care and the quality of general newborn care after birth, which affects both bacterial colonization and the time of umbilical remnant separation [26].
In full-term infants, the first clinical signs of omphalitis appear on days 5–9; in premature infants, the disease usually develops on days 3–5.
1.4 Features of Coding the Disease or Condition
P38 Omphalitis of newborn with or without mild hemorrhage.
1.5 Classification of the disease or condition
Classification by clinical forms [29]:
– purulent (simple) omphalitis;
– phlegmonous omphalitis (diffuse purulent);
– necrotizing omphalitis.
Classification of omphalitis by stages depending on the severity and progression of the infectious process:
Stage I: funisitis (vasculitis of the umbilical vessels) with purulent discharge from the umbilical cord, unpleasant odor.
Stage II: funisitis with purulent discharge from the umbilical cord, unpleasant odor, phlegmon of the abdominal wall in the periumbilical region.
Stage III: funisitis with purulent discharge from the umbilical cord, unpleasant odor, phlegmon, and generalization of the infectious process (sepsis, shock, disseminated intravascular coagulation, multiorgan dysfunction syndrome).
Stage IV: funisitis with purulent discharge from the umbilical cord, unpleasant odor; phlegmon of the abdominal wall, ecchymoses, signs of involvement of the superficial and deep fascia and muscles of the anterior abdominal wall, and generalization of the infectious process (sepsis, shock, disseminated intravascular coagulation, multiorgan dysfunction syndrome) [27–29].
1.6 Clinical presentation of the disease or condition
The presence of scanty discharge from the umbilical stump in the absence of inflammatory signs may be a normal phenomenon, even if accompanied by some odor. Serous discharge from the umbilical wound, slow healing of the umbilical wound after separation of the umbilical stump (more than two weeks); moderate erythema of the umbilical ring without infiltration and edema, and the absence of signs of infectious toxicosis are signs of the physiological process of mummification and separation of the umbilical remnant.
In purulent omphalitis, the following are noted:
– local hyperemia of the umbilical ring;
– edema of the umbilical ring;
– infiltration of the subcutaneous adipose tissue around the umbilical ring;
– a long-healing umbilical wound that periodically becomes covered with a crust, from which seropurulent discharge is secreted;
– an unpleasant odor from the umbilical remnant or the discharge from the umbilical wound;
– excessive proliferation of granulating tissue is possible, leading to the formation of a fungus. The general condition of the child is not compromised;
– bleeding from the umbilical stump may occur because infection delays thrombosis of the umbilical vessels.
Signs of infectious toxicosis, such as lethargy or hyperexcitability, hyperesthesia, fever, refusal to feed, weight loss, and regurgitation, indicate generalization of the process.
In phlegmonous (diffuse purulent) omphalitis, in addition to the symptoms described above, the following are noted:
– spread of the inflammatory process to surrounding tissues;
– hyperemia and infiltration of the skin in the area of the umbilical ring;
– ulceration of the umbilical wound, presence of fibrinous deposits on the bottom of the wound with a dense skin rim around it;
– discharge of pus from the umbilical wound upon pressure on the periumbilical region;
– phlegmon of the anterior abdominal wall;
– signs of generalization of the process (deterioration of the general condition, increasing intoxication, elevated body temperature).
Necrotizing omphalitis is observed in debilitated infants when an anaerobic infection joins. Necrosis of the skin and subcutaneous tissue in the umbilical region is added to the listed signs. The necrotizing process can involve all layers of the anterior abdominal wall and cause peritonitis. Mummification of the umbilical remnant halts; it becomes moist, acquires a dirty-brown hue and an unpleasant putrid odor.
The most frequent complication of omphalitis is sepsis. Other complications include septic umbilical arteritis, portal vein thrombosis, liver abscess, peritonitis, intestinal gangrene, small bowel perforation, necrotizing fasciitis, and death.
In omphalitis and delayed separation of the umbilical remnant, it is necessary to rule out congenital anomalies: persistence of a part of the embryonic tract (patent urachus) and free communication between the urinary bladder and the umbilicus, which can lead to constant drainage from the umbilicus and be mistakenly perceived as an infectious symptom. Incomplete obliteration of the urachal remnant can lead to the formation of an isolated extraperitoneal cyst, which may manifest with a secondary bacterial infection mimicking omphalitis. If congenital developmental anomalies are suspected, it is advisable to consult a pediatric surgeon and a geneticist (initial appointment (examination, consultation) with a pediatric surgeon and a geneticist) to rule out syndromic pathology and resolve the issue of the need for surgical treatment.
2. Diagnostics, medical indications and contraindications for diagnostic methods
Criteria for diagnosis establishment: The diagnosis is established based on a combination of data:
1) anamnestical data (presence of risk factors and predisposing factors) [6],
2) physical examination (see the "Clinical Presentation" section),
3) laboratory tests (presence of signs of an infectious process),
4) instrumental examination (exclusion of congenital developmental anomalies, diagnosis of portal vein thrombosis, abscesses),
5) conclusion of a relevant specialist (pediatric surgeon, geneticist, allergist-immunologist, etc.) if indications are present.
2.1 Complaints and Anamnesis
A newborn infant with suspected omphalitis is recommended to have the mother's medical history reviewed (collection of obstetric-gynecological history and complaints) to identify risk factors for omphalitis [6, 27].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
Comments:
Maternal risk factors for developing omphalitis include the presence of an acute infection in the mother or exacerbation of a chronic one; chorioamnionitis [6].
Neonatal factors include:
- low birth weight;
- prolonged labor;
- prolonged rupture of membranes;
- home birth;
- umbilical vessel catheterization;
- violation of sanitary and anti-epidemic regulations in the ward.
2.2 Physical Examination
See Section 1.6 "Clinical Presentation".
A newborn infant with suspected omphalitis is recommended to undergo a therapeutic physical examination [2, 30].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: The therapeutic visual examination includes: inspection of the infant's mucous membranes and skin, therapeutic auscultation (lungs, heart, abdominal cavity), therapeutic palpation (abdomen, periumbilical region), general thermometry, and neurological status assessment.
2.3 Laboratory Diagnostics
A newborn infant with suspected omphalitis is recommended to undergo a complete blood count (CBC) to confirm the inflammatory process and determine further treatment tactics [3, 32].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
A newborn infant with suspected omphalitis is recommended to undergo a serum C-reactive protein (CRP) test to confirm the inflammatory process and determine further treatment tactics [31, 33, 34].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
To select the optimal antibacterial therapy for a newborn infant with omphalitis, it is recommended to perform a microbiological (culture) examination of purulent discharge from the umbilical wound for aerobic and facultatively anaerobic microorganisms, along with antimicrobial susceptibility testing [34–36].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
A newborn infant with omphalitis is recommended to undergo a complete blood count (CBC) upon completion of a course of systemic antibacterial drugs (ATC code J01) to determine further antibacterial treatment tactics [31, 37, 69].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
A newborn infant with omphalitis is recommended to undergo a serum C-reactive protein (CRP) test upon completion of a course of systemic antibacterial drugs (ATC code J01) to determine further antibacterial treatment tactics [31, 38, 39].
GRC BLEL 2Grade of Recommendation B (Level of Evidence – 2)
In a newborn infant with omphalitis showing no positive clinical dynamics after 72 hours of antibacterial therapy, it is recommended to perform a serum C-reactive protein (CRP) test to address the escalation/switching of current systemic antibacterial drugs (ATC code J01) [31, 40, 41].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
In a newborn infant with omphalitis showing no positive clinical dynamics after 72 hours of antibacterial therapy, it is recommended to undergo a complete blood count (CBC) to address the escalation/switching of current systemic antibacterial drugs (ATC code J01) [31, 40, 69].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comment: in cases of pronounced antibiotic resistance or lack of positive clinical dynamics despite ongoing antibacterial therapy, a consultation with a clinical pharmacologist is indicated to adjust the antibacterial treatment strategy.
2.4 Instrumental Diagnostics
To rule out an inflammatory process in the abdominal organs, a newborn with signs of necrotic and phlegmonous omphalitis is recommended to undergo a complex ultrasound examination (ultrasonography) of the abdominal organs, kidneys, and adrenal glands [30, 42, 43].
GRC BLoE 5Grade of Recommendation B (Level of Evidence – 5)
2.5 Other Procedures
Not applicable.
3. Treatment, including drug and non-drug therapies, diet therapy, and pain management
3.1 Conservative Treatment
For etiotropic treatment of a newborn infant with purulent omphalitis, it is recommended to prescribe systemic antibacterial drugs (ATC code J01). Empirical therapy includes broad-spectrum penicillins (ATC code J01CA) (ampicillin**) combined with other aminoglycosides (ATC code J01GB) (#gentamicin**, amikacin**), or penicillin combinations, including combinations with beta-lactamase inhibitors (ATC code J01CR) (Amoxicillin + [Clavulanic acid]**). If methicillin-resistant Staphylococcus aureus (MRSA) is identified, glycopeptide antibiotics (ATC code J01XA) vancomycin** are prescribed [31, 44–47, 70]. The dosing regimen for #gentamicin** in neonates depends on gestational age (GA) and postnatal age: GA less than 29 weeks: 0–7 days of life – 5 mg/kg/48 h, 8–28 days – 4 mg/kg/36 h, more than 29 days – 4 mg/kg/24 h; GA 30–34 weeks: 0–7 days – 4.5 mg/kg/36 h, more than 8 days – 4 mg/kg/24 h; 35 weeks and older – 4 mg/kg/24 h intravenously as an infusion over 30–120 minutes [73].
tabular(A)LEL 1Level of recommendation reliability A (level of evidence – 1 for #gentamicin** and ampicillin**, 2 for Amoxicillin + [Clavulanic acid]**, amikacin**, vancomycin**)
Comments: treatment of omphalitis requires the prescription of systemic antibacterial drugs (ATC code J01) covering both gram-positive and gram-negative microorganisms [1].
As the main agents of empirical therapy, broad-spectrum penicillins (ATC code J01CA) (ampicillin**) combined with other aminoglycosides (ATC code J01GB) (#gentamicin**, amikacin**), as well as penicillin combinations including combinations with beta-lactamase inhibitors (ATC code J01CR) (Amoxicillin + [Clavulanic acid]**) should be used [47, 70]. Given the susceptibility of amoxicillin** (ATC code J01CA04) to degradation by β-lactamases produced by various microorganisms, penicillin combinations with beta-lactamase inhibitors should be used—for example, Amoxicillin + [Clavulanic acid]** (ATC code J01CR02)—administered either parenterally or enterally as an oral suspension.
The intravenous route of administration for systemic antibacterial drugs (ATC code J01) is used:
- when emergency treatment of a severe, progressive form of the disease is required, necessitating rapid achievement of high drug concentrations in tissues;
- in the presence of contraindications for enteral feeding;
- when systemic antibacterial drugs (ATC code J01) are not available in oral formulations.
In purulent omphalitis, systemic antibacterial drugs (ATC code J01) intended for per os administration should be used—Amoxicillin + [Clavulanic acid]** (oral suspension) (ATC code J01CR02).
The administration of systemic antibacterial drugs (ATC code J01) per os in neonates has many limitations. Thus, this route is unacceptable in premature infants, especially those with extremely low birth weight (less than 1000 g), as well as in critically ill infants (shock, hypovolemia, decompensated acidosis, hypoxia, need for mechanical ventilation in aggressive modes); if oral administration of systemic antibacterial drugs (ATC code J01) proves ineffective, therapy is continued via the parenteral route.
Nevertheless, for breastfed or formula-fed infants with localized forms of infectious and inflammatory diseases, it is advisable to prescribe oral administration of those systemic antibacterial drugs (ATC code J01) that are most effective specifically via this route. In each specific case, venous catheterization (cubital or other peripheral veins) and the intravenous route of administration for the systemic antibacterial drug (ATC code J01) must be strongly justified.
In phlegmonous and necrotic omphalitis, pending the results of culture and antimicrobial susceptibility testing (microbiological (culture) examination of purulent discharge from the umbilical wound for aerobic and facultatively anaerobic microorganisms and determination of antimicrobial susceptibility), parenteral (intravenous or intramuscular) administration of broad-spectrum penicillins (ATC code J01CA) combined with other aminoglycosides (ATC code J01GB) is advisable; doses, route, and frequency of administration are determined by the drug's instructions.
Correction of antibacterial therapy should be performed based on the results of microbiological (culture) examination of purulent discharge from the umbilical wound for aerobic and facultatively anaerobic microorganisms 72 hours after treatment initiation, if there is no improvement in clinical and laboratory indicators demonstrating positive disease dynamics and/or in case of pathogen resistance to the ongoing therapy [31, 47–50].
If methicillin-resistant Staphylococcus aureus (MRSA) is identified, glycopeptide antibiotics (ATC code J01XA) (vancomycin**) are prescribed; doses, route, and frequency of administration are determined by the drug's instructions [8].
For a newborn child with omphalitis, in order to treat the local inflammatory process, it is recommended to care for the newborn's umbilical wound using antiseptics and disinfectants (ATC code D08A) — biguanides and amidines (ATC code D08AC) — chlorhexidine** 0.02% [51–54].
GCR ALEL 1Grade of Recommendation A (Level of Evidence – 1)
Comments: the following are used as antiseptics and disinfectants (ATC code D08A): biguanides and amidines (ATC code D08AC) — chlorhexidine** 0.02% solution for local and external use [55]. Before treatment, the umbilical stump must be removed. Antiseptics and disinfectants (ATC code D08A) should be used with caution and must not contain substances aggressive to the skin of newborns, especially preterm infants, to prevent chemical burns.
3.2 Surgical Treatment
For a newborn child with necrotizing fasciitis and myonecrosis, to prevent the spread of the inflammatory process, it is recommended to perform early and complete surgical debridement of the wound or infected tissues [57].
LeRR CLoE 4Level of recommendation confidence C (level of evidence – 4)
3.3 Other Treatment
The developmental care regime involves creating optimal conditions for nursing newborns.
4. Medical Rehabilitation and Sanatorium-Resort Treatment
Not applicable.
5. Prevention and Dispensary Observation
Technique of umbilical cord clamping and management of the umbilical cord remnant in the delivery room [30]:
The newborn is received into a sterile receiving blanket. A medical kit for newborns (obstetric) is used for the initial processing of the newborn.
Clamping and transection of the umbilical cord should be performed no earlier than 1 minute after birth:
- Apply one toothed hemostatic clamp to the umbilical cord at a distance of 10 cm from the umbilical ring.
- Apply the second toothed hemostatic clamp to the umbilical cord as close as possible to the parturient woman's external genitalia.
- Apply the third toothed hemostatic clamp 2 cm outward from the first; wipe the segment of the umbilical cord between the first and third toothed hemostatic clamps with a sterile medical gauze wipe moistened with ethanol** (ATC code D08AX08) 70% solution, and transect with sterile medical scissors.
Management and transection of the umbilical cord remnant:
Currently, the most reliable and safest method is a disposable umbilical clamp/umbilical cord clamp (disposable sterile umbilical clamp), which is applied to the umbilical cord remnant.
The application of the umbilical cord clamp is performed by the maternity ward midwife in the delivery room after the baby is first put to the breast.
Before applying the umbilical/umbilical cord clamp, personnel perform hygienic hand antisepsis. The site of application of the umbilical/umbilical cord clamp is treated with ethanol** (ATC code D08AX08) 70% solution.
Technique of umbilical cord clamp application [30]:
- Change gloves;
- Perform hygienic hand antisepsis;
- Put on sterile gloves (sterile surgical latex gloves);
- Express blood from the umbilical ring toward the periphery using a sterile medical gauze wipe;
- Treat the umbilical cord segment with ethanol** (ATC code D08AX08) 70% solution using a sterile medical gauze wipe;
- Apply the umbilical/umbilical cord clamp (disposable sterile umbilical clamp) to the umbilical cord remnant at a distance of 2–3 cm, but not less than 1 cm from the umbilical ring. Applying the clamp too close to the skin may cause chafing of the umbilical ring skin;
- After applying the clamp, transect the umbilical tissue above the clamp, wipe away blood with a sterile gauze wipe;
- Application of a gauze dressing and repeated treatment of the umbilical cord remnant immediately after clamp application are not indicated.
For the prevention of omphalitis during umbilical cord remnant care, it is not recommended to create sterile conditions for a newborn child. It is sufficient to keep the umbilical cord remnant dry and clean, protect it from contamination with urine and feces, as well as from trauma — exclude tight swaddling or the use of medical diapers for children/infants with tight fixation [58].
GRC BLEL 2Grade of Recommendation B (Level of Evidence – 2)
Comments: the umbilical cord remnant undergoes natural mummification and separates spontaneously within 2 weeks. Complete epithelialization of the umbilical wound occurs within 3–4 weeks after birth.
In case of contamination (with urine or feces), the umbilical cord remnant and the skin around the umbilical ring should be washed with water and liquid soap used in the department, and dried with a clean sterile medical gauze wipe [54, 55, 59–63]. In developed countries with a low incidence of omphalitis, the efficacy and safety of the "dry" care method for the umbilical cord remnant have been proven.
For a newborn child born outside a medical institution, as well as in countries with a high neonatal mortality rate, it is recommended to treat the umbilical cord remnant with an antiseptic and disinfectant (ATC code D08A) — biguanides and amidines (ATC code D08AC) — chlorhexidine** 0.02% to prevent omphalitis and reduce neonatal mortality [55].
GCR ALEL 1Grade of Recommendations A (Level of Evidence – 1)
For the prevention of omphalitis in a newborn child, it is not recommended to additionally apply a surgical suture/surgical suture material to the umbilical stump for accelerated detachment, nor is prophylactic treatment of the umbilical cord remnant recommended with antiseptics and disinfectants (ATC code D08A) — biguanides and amidines (ATC code D08AC) — chlorhexidine** 0.02%, other medicinal products (ATC code V03A) — methylthioninium chloride, or other antiseptics and disinfectants (ATC code D08AX) — ethanol**, potassium permanganate** [30, 59, 64].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: local use of antiseptics and disinfectants (ATC code D08A), other medicinal products (ATC code V03A) — methylthioninium chloride, other antiseptics and disinfectants (ATC code D08AX) — ethanol**, potassium permanganate**, etc., not only fails to reduce the frequency of infections, but also contributes to the delayed spontaneous detachment of the umbilical cord remnant.
For the prevention of omphalitis in a newborn child, it is not recommended to forcibly remove (cut off) the umbilical cord remnant [30].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: such a procedure can cause severe complications (bleeding, injury to the intestinal wall in case of an undiagnosed omphalocele, infection).
Dispensing follow-up is not provided.
6. Organization of Medical Care
Treatment of neonatal omphalitis is carried out in inpatient settings.
The registration of signs of omphalitis is an indication for hospitalization in the neonatal pathology department. For operational (daily) registration of purulent-inflammatory diseases, including the implementation of anti-epidemic measures in the established manner, the attending neonatologist informs the head of the department (head (chief) of a structural subdivision (department, unit, laboratory, office, team, etc.) of a medical organization — medical specialist, specialist) and the hospital epidemiologist (assistant epidemiologist) about the case(s) of phlegmonous and/or necrotic forms of omphalitis in newborn(s).
In the event of the development of phlegmonous and necrotic forms of omphalitis, consultation with a pediatric surgeon (initial examination, consultation by a pediatric surgeon) is indicated to confirm the diagnosis and for hospitalization in the pediatric surgery department; if congenital anomalies are suspected, consultation with a geneticist (initial examination, consultation by a geneticist) is indicated to rule out syndromic pathology [65–68].
The timing of discharge from the obstetric inpatient facility is determined by the health status of the mother and child. Discharge of the newborn from the hospital does not depend on the time of detachment of the umbilical cord remnant. Before discharge, the neonatologist provides counseling to the mother/parents on newborn care issues, including skin and umbilical cord remnant care, with a corresponding note in the newborn's medical documentation.
Indications for patient discharge from a medical organization:
Stable and satisfactory condition of the child;
Stabilization of laboratory parameters;
Absence of local inflammatory manifestations of the umbilical wound and periumbilical ring;
Absence of contraindications for discharge.
6.1 Organization of epidemiological surveillance
Epidemiological surveillance of omphalitis and healthcare-associated infections in a medical organization is carried out using passive and active methods.
1. Passive method — involves reporting by medical workers to the hospital epidemiologist of each detected case of omphalitis (suspected omphalitis), cases of healthcare-associated infections among newborns and postpartum women, and the results of bacteriological studies.
2. Active method — active search and detection by the hospital epidemiologist of healthcare-associated infection cases using standard case definitions and laboratory test results of patients from risk groups.
The following is used for active case detection:
- participation in operational medical meetings of the organization where patient disease cases are reviewed;
- participation in patient examinations during rounds, dressings, and procedures.
- review of the federal integrated electronic medical record or the paper version of the inpatient medical history of patients who have been hospitalized for a longer period than the average number of bed-days provided for the primary disease for certain clinical-statistical groups (CSG); are receiving systemic antibacterial drugs (J01) to manage an infectious process unrelated to the primary disease; are undergoing additional laboratory-diagnostic examinations or physiotherapeutic procedures [48].
6.2 Detection, accounting, and registration of omphalitis cases
Cases of omphalitis are subject to registration, accounting, and statistical surveillance. Heads of medical organizations that have identified a patient must ensure the completeness, accuracy, and timeliness of recording cases of omphalitis, as well as prompt notification of them to the territorial body authorized to exercise federal state sanitary and epidemiological supervision.
Each case of omphalitis must be registered in the register of infectious diseases at the place of its detection and the place of patient infection within medical organizations, as well as in territorial bodies authorized to exercise federal state sanitary and epidemiological supervision. All cases of omphalitis are recorded at the place where the patient was infected.
If a case of omphalitis is detected after discharge or transfer of the patient to another hospital, the medical organization that detected the omphalitis must transmit the information to the territorial bodies authorized to exercise federal state sanitary and epidemiological supervision, which within 12 hours shall transmit information about the registered omphalitis to the medical organization at the site of suspected infection.
Group outbreaks should be considered as 5 or more cases of omphalitis linked to a single source of infection and/or common transmission factors. The medical organization shall report the occurrence of group cases of omphalitis of any etiology to the bodies authorized to exercise federal state sanitary and epidemiological supervision in accordance with the established procedure for submitting emergency reports on sanitary and epidemiological emergencies.
Neonatal cases of omphalitis detected during the stay in an obstetric hospital and/or within 7 days after discharge must be recorded by this hospital.
7. Additional Information
The prognosis of the disease in the absence of comorbid conditions is generally favorable. In necrotic and phlegmonous forms of omphalitis, involvement of internal organs, generalization of the infectious process, and sepsis are possible.
Differential diagnosis should be performed with the following diseases and conditions [71, 72]:
umbilical granuloma (visible granuloma at the base of the umbilicus);
remnants of the omphalomesenteric duct (cystic tumor or fistula opening);
patent urachus (fistula opening or cyst).
Criteria for Evaluating the Quality of Medical Care
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Appendix A1. Working Group Composition
Alexandrovsky Anatoly Vikentyevich – Candidate of Medical Sciences, Neonatologist at the Department of Pathology of Newborns and Premature Infants, Institute of Neonatology and Pediatrics, V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Russian Ministry of Health, Member of the Russian Society of Neonatologists.
Balashova Ekaterina Nikolaevna – Candidate of Medical Sciences, Leading Researcher at the Prof. A.G. Antonov ICU, Institute of Neonatology and Pediatrics; Associate Professor at the Department of Neonatology, Institute of Professional Education, V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Russian Ministry of Health; Associate 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.
Zubkov Viktor Vasilyevich – Doctor of Medical Sciences, Director of the Institute of Neonatology and Pediatrics, V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Russian Ministry of Health; 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.
Kukhartseva Marina Vyacheslavovna – Researcher at the Department of Pathology of Newborns and Premature Infants, Institute of Neonatology and Pediatrics, V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Russian Ministry of Health, Member of the Russian Society of Neonatologists.
Markelova Marina Mikhailovna – Neonatologist, Researcher at the Department of Pathology of Newborns and Premature Infants, Institute of Neonatology and Pediatrics, V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Russian Ministry of Health, Member of the Russian Society of Neonatologists.
Narogan Marina Viktorovna – Doctor of Medical Sciences, Leading Researcher at the Department of Pathology of Newborns and Premature Infants, Institute of Neonatology and Pediatrics, V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Russian Ministry of Health; 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.
Orlovskaya Irina Vladimirovna – Candidate of Medical Sciences, Senior Researcher, Head of Clinical Work at the Department of Pathology of Newborns and Premature Infants; Associate Professor at the Department of Neonatology, Institute of Neonatology and Pediatrics, V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Russian Ministry of Health, Member of the Russian Society of Neonatologists.
Priputnevich Tatyana Valeryevna – Doctor of Medical Sciences, Corresponding Member of the RAS, Director of the Institute of Microbiology, Antimicrobial Therapy and Epidemiology, V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Russian Ministry of Health.
Ryumina Irina Ivanovna – Doctor of Medical Sciences, Head of the Department of Pathology of Newborns and Premature Infants, Professor at the Department of Neonatology, Institute of Neonatology and Pediatrics, V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Russian Ministry of Health, Honored Doctor of the Russian Federation, Member of the Russian Society of Neonatologists.
Conflict of interest: none.
Appendix A2. Methodology for Developing Clinical Guidelines
Methods used for collecting/selecting evidence: electronic database search.
Description of methods used for evidence collection/selection: the evidence base for the recommendations included publications from the Cochrane Library, PubMed, EMBASE and 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 was 40 years.
Methods used for assessing the quality and strength of evidence:
expert consensus;
assessment of significance in accordance with the rating scheme.
Grading scales for evidence levels (Tables 1, 2) for diagnostic, preventive, therapeutic, and rehabilitation methods (interventions) with definitions, and the grading scale for recommendation strength levels (Table 3) for preventive, diagnostic, therapeutic, and rehabilitation methods (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 reviewed.
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 in these guidelines 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 Russian Association of Perinatal Medicine Specialists (RAPMS) www.raspm.ru so that all interested parties could participate in discussing and improving the guidelines.
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;
general practitioners (family physicians)
Table 1. Scale for assessing levels of evidence (LE) 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 the levels of evidence (LE) for prevention, treatment, and medical rehabilitation methods, 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 rehabilitation 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 of November 21, 2011, "On the Fundamentals of Protecting the Health of Citizens in the Russian Federation".
Order of the Russian Ministry of Health dated April 14, 2025, No. 203n "On approval of criteria for assessing the quality of medical care."
International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10). URL: https://nsi.rosminzdrav.ru/dictionaries/1.2.643.5.1.13.13.11.1005/passport/2.27
Order of the Ministry of Health of the Russian Federation No. 804n dated October 13, 2017, "On Approval of the Nomenclature of Medical Services."
Order of the Russian Ministry of Health No. 222n dated April 17, 2025, "On Approval of the Procedure for Providing Medical Care in the Profile 'Neonatology'."
Decree of the Government of the Russian Federation No. 3867-r dated December 18, 2025 "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".
State Register of Medicines: URL: https://grls.rosminzdrav.ru
Order of the Chief State Sanitary Doctor of the Russian Federation No. 4 dated January 28, 2021, "On the Approval of Sanitary Rules and Norms SanPiN 3.3686-21 'Sanitary and Epidemiological Requirements for the Prevention of Infectious Diseases'" (along with "SanPiN 3.3686-21. Sanitary Rules and Norms...").
Appendix B. Physician Action Algorithms
Appendix C. Patient Information
Omphalitis is a neonatal disease caused by an infection of the umbilical cord remnant or umbilical wound. The development of the disease is facilitated by the presence of an acute infection or exacerbation of chronic infections in the mother, chorioamnionitis, low birth weight in the infant, prolonged labor with a long rupture of membranes, home birth, lack of hygiene, and proper care. The skin barrier function is not yet mature, and the infant's immune system is still developing, so the inflammatory process can progress quite rapidly.
Minor discharge from the umbilical stump in the absence of inflammatory signs may be normal, even if accompanied by some odor. There are several forms of omphalitis. The signs of catarrhal omphalitis include: clear mucous discharge from the umbilical wound, slow healing of the umbilical wound after the umbilical stump detaches (more than two weeks), moderate redness of the umbilical ring, while symptoms of infectious toxicosis are absent, and body temperature is normal. Purulent omphalitis is characterized by more pronounced redness of the umbilical ring, edema, a long-healing umbilical wound that periodically becomes crusty and secretes purulent discharge. There is an unpleasant odor from the umbilical stump or discharge from the umbilical wound, and excessive proliferation of granulation tissue resembling a mushroom in silhouette may occur. The general condition of the infant is not affected. Bleeding from the stump may occur because the infection delays thrombosis of the umbilical vessels. If lethargy, drowsiness, or conversely, excessive irritability, fever, refusal to feed, weight loss of more than 10% of birth weight, or profuse regurgitation more than 2–3 times a day appear alongside these signs, it means the infection is spreading. In the phlegmonous form, redness in the umbilical region increases, fever intensifies, the umbilical wound more closely resembles an ulcer with a dense skin ridge around it, pus appears upon pressure, and the general condition deteriorates. In the most severe form—necrotic omphalitis—necrosis (death and blackening of the skin and subcutaneous tissue) around the umbilicus is observed. Treatment of the purulent form is carried out in the neonatal pathology department, while the phlegmonous and necrotic forms require surgical treatment in the neonatal surgery department.
To diagnose omphalitis in an infant, a comprehensive blood test (complete [clinical] blood count, differential), instrumental examination methods are performed, and consultation with other specialists may be required, such as a pediatric surgeon (initial appointment [examination, consultation] of a pediatric surgeon). Treatment depends entirely on the form of the disease and the severity of the infant's condition. The catarrhal form requires only local treatment, adherence to hygiene, and dynamic monitoring by the attending physician. Other forms require antibacterial therapy for 5–7 days; severe forms may require surgical treatment.
Prevention of omphalitis involves preventing infectious diseases in the mother during pregnancy and before delivery, curing existing infections, achieving remission of chronic conditions, delivery in a specialized facility with adherence to asepsis and antisepsis rules, timely clamping of the umbilical cord, hygiene, and proper skin care of the newborn after birth. The umbilical stump undergoes natural mummification and spontaneous separation within 2 weeks. Final healing of the umbilical wound occurs within 3–4 weeks after birth. Caring for the umbilical stump does not require sterile conditions; it is sufficient to keep the umbilical stump dry and clean, protect it from contamination with urine and feces, as well as from trauma—avoid tight swaddling or the use of disposable diapers with tight fixation. In case of contamination (with urine or feces), the umbilical stump and the skin around the umbilical ring must be washed with water and liquid soap used in the department, and dried with a clean gauze wipe.
The prognosis is favorable with timely and high-quality treatment. Premature infants require significantly more time for treatment and recovery. It is very important to maintain a positive attitude and support breastfeeding—these two factors are the key to a favorable outcome.
Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools
Not applicable.