Infant of a mother with diabetes syndrome: clinical guidelines

Applies tochildren2025 editionP70.0, P70.1

Clinical Guidelines of the Russian Ministry of Health, Pediatrics. 2025 Edition, ICD-10 codes: P70.0, P70.1.

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Brief for Practice

WhiteCoat Pro editorial summary of the guideline text, 2025 edition. Each item links to the original section — verify against it before prescribing.

Diabetic fetopathy is a multisystem neonatal condition in infants born to mothers with pregestational or gestational diabetes mellitus; the key mechanism is fetal hyperinsulinemia driven by maternal hyperglycemia. This guideline focuses on the early detection of hypoglycemia and other disorders, their management, and inpatient monitoring of the newborn.

Key points

Diagnostics

  1. If diabetic fetopathy is suspected, review the maternal medical history to identify carbohydrate metabolism disorders during pregnancy (Level of Reliable Evidence C, Grade of Recommendation 5). → in the text
  2. Perform a physical examination of the newborn and evaluate for signs of diabetic fetopathy: macrosomia, fat deposits, hepatomegaly, hypotonia, and other clinical manifestations (Level of Reliable Evidence C, Grade of Recommendation 3). → in the text
  3. Determine blood glucose 1–2 hours after birth, then every 4 hours until the end of the first day of life (Level of Reliable Evidence C, Grade of Recommendation 5). Monitoring can be discontinued earlier if the infant has been put to the breast, shows no pathological signs on clinical examination, and has two consecutive normal results. → in the text
  4. To determine further management tactics, assess hematocrit, total blood calcium, and serum total magnesium (Level of Reliable Evidence C, Grade of Recommendation 5). In the presence of jaundice, additionally measure total bilirubin (Level of Reliable Evidence C, Grade of Recommendation 5). → in the text
  5. Perform echocardiography to detect hypertrophic cardiomyopathy and possible minor congenital heart defects (Level of Reliable Evidence C, Grade of Recommendation 3). → in the text

Treatment

When to refer and how to monitor

Frequently asked questions

When should blood glucose be checked in a newborn born to a mother with diabetes?

The first measurement is performed 1–2 hours after birth, and then every 4 hours until the end of the first day. Monitoring can be stopped earlier after two consecutive normal results if the infant has been put to the breast and shows no pathological signs on clinical examination. → in the text

At what glucose level should treatment be initiated?

The hypoglycemia treatment threshold in the guideline is less than 2.6 mmol/L. At this level, intravenous administration of 10% dextrose is recommended; asymptomatic hypoglycemia is initially managed with feeding. → in the text

What signs may indicate hypoglycemia?

Possible signs include sweating, pallor, irritability, tremor, irregular breathing, and tachycardia. With more pronounced glucose drops, apnea, poor suckling, hypotonia, seizures, and central nervous system depression up to coma may occur, though hypoglycemia can also be completely asymptomatic. → in the text

Is echocardiography necessary for all infants born to mothers with diabetes?

Yes. Newborns born to mothers with pregestational or gestational diabetes mellitus undergo echocardiography to detect hypertrophic cardiomyopathy and possible minor congenital heart defects. → in the text

What tests are needed when diabetic fetopathy is suspected, besides blood glucose?

Hematocrit, total calcium, and total magnesium are evaluated; in the presence of jaundice, total bilirubin is determined. These results are used to determine further management tactics. → in the text

Status
Applied · approved by the Scientific and Practical Council of the Russian Ministry of Health
Database ID
907, edition 1 (ID 907_1)
Publication date
April 15, 2025
Age category
children
ICD-10 codes
P70.0P70.1
Specialties
NeonatologyObstetrics and GynecologyPediatrics
Developers
All-Russian Public Organization for the Promotion of Neonatology Development «Russian Society of Neonatologists»
Association of Specialists in Perinatal Medicine, Healthcare for Pregnant Women, Fetuses, Newborns, and Children Under 3 Years of Age (ASPM)
Official text
Ministry of Health of Russia Rubricator — 907_1

List of Abbreviations

IGF1 – insulin-like growth factor 1

IGFBP-3 – insulin-like growth factor-binding protein 3

GDM – gestational diabetes mellitus

DF – diabetic fetopathy

DM – diabetes mellitus

T2DM – type 2 diabetes mellitus

US – ultrasound examination

CNS – central nervous system

Terms and Definitions

Diabetes mellitus – a group of endocrine diseases associated with impaired carbohydrate metabolism due to absolute or relative (impaired interaction with target cells) deficiency of the hormone insulin, leading to hypo- or hyperglycemia; in chronic cases, it is accompanied by damage, dysfunction, and failure of various organs, especially the eyes, kidneys, nerves, heart, and blood vessels [1].

Diabetic embryofetopathy – a clinical and metabolic syndrome detected in newborns who developed intrauterine exposure to decompensated maternal diabetes mellitus [2,3].

Diabetic fetopathy – a neonatal disorder developing in infants whose mothers suffer from diabetes mellitus or gestational diabetes, characterized by multisystem involvement, metabolic, and endocrine dysfunctions [4,5].

Hyperglycemia – blood glucose level above normal values

Hypoglycemia – blood glucose level below normal values

Glycemia – blood glucose concentration

Macrosomia – birth weight greater than 4000 g or above the 90th percentile using international standards for assessing fetal size for gestational age [6]

1. Brief information on the disease or condition

1.1 Definition of the disease or condition

Diabetic embryofetopathy – a clinical and metabolic syndrome detected in newborns who developed intrauterine exposure to decompensated maternal diabetes mellitus [2,3].

Depending on the time of onset of the pathology, the following forms are distinguished:

Diabetic embryofetopathy – a clinical and laboratory complex developing in infants whose mothers suffer from diabetes mellitus, including characteristic external features and malformations (injury occurring up to 12 weeks of intrauterine life);

Diabetic fetopathy (DF) - a general term for fetal disorders in mothers suffering from diabetes mellitus (DM), occurring after 12 weeks of intrauterine life and prior to the onset of labor.

Diabetic fetopathy (DF) is defined as a neonatal condition developing in newborns whose mothers have diabetes mellitus or gestational diabetes mellitus (GDM), characterized by multisystem involvement, metabolic, and endocrine dysfunctions [4,5].

1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)

The primary etiological factor in the development of DF is maternal hyperglycemia in a mother with DM or GDM [4]. During pregnancy, glucose is continuously transferred from the mother to the fetus, and the relationship between maternal and fetal glucose concentrations is linear in the middle and late stages of pregnancy [7]. Maternal insulin does not cross the placenta, and the fetus produces its own insulin [8–10].

Maternal hyperglycemia stimulates fetal synthesis of insulin-like growth factor 1 (IGF1) and insulin-like growth factor-binding protein 3 (IGFBP-3) [11,12], leading to pancreatic cell hyperplasia and a compensatory increase in insulin levels [13].

Insulin is the primary fetal growth factor. Constant fetal hyperinsulinemia leads to increased protein synthesis and lipogenesis, which cause macrosomia [14]. Insulin also increases glycogen synthesis and deposition, primarily in the liver and heart, causing hepatomegaly and cardiomyopathy. During fluctuations in maternal blood glucose, maternal hypoglycemia stimulates fetal production of glucocorticoids and glucagon, leading to hypercorticism in the infant [15]. Thus, the main pathogenetic mechanism of DF is fetal hyperinsulinemia, occasionally combined with hypercorticism. In addition, hyperinsulinemia inhibits the effect of glucocorticoid hormones on lung maturation and delays surfactant synthesis [16–18]. The triggering factor for neonatal hypoglycemia is placental separation during delivery, which stops glucose supply to the fetus against the background of hyperinsulinemia [19,20].

1.3 Epidemiology of the Disease or Condition

Approximately 366 million people worldwide suffer from DM, and this number is expected to double by 2030 [21]. Parallel to the rising prevalence of diabetes mellitus, there is an increase in cases of gestational diabetes mellitus [22]. In the USA, 1–5% of pregnancies are complicated by hyperglycemia, with only 0.2–0.3% of pregnant women having pre-existing DM before pregnancy [23]. According to the International Diabetes Federation (IDF), 21.3 million (16.2%) children born in 2017 were exposed to varying degrees of hyperglycemia during intrauterine development [24,25].

Improving DM control during pregnancy and screening all pregnant women for GDM lead to a significant reduction in the severity of DF in fetuses and newborns, up to a complete absence of symptoms [26].

1.4 Features of Coding the Disease or Condition

P70 Transitory disorders of carbohydrate metabolism specific to fetus and newborn

P70.0 Syndrome of infant of mother with gestational diabetes.

Fetus or newborn (with hypoglycemia) caused by maternal gestational diabetes.

P70.1 Syndrome of infant of mother with diabetes mellitus.

Fetus or newborn (with hypoglycemia) caused by maternal diabetes mellitus (pre-existing).

1.5 Classification of the disease or condition

Not applicable

1.6 Clinical presentation of the disease or condition

One of the main clinical manifestations of DF is hypoglycemia at birth, which occurs in 13–63.8% of newborns born to mothers with DM or GDM. Hypoglycemia is detected as early as the first 2–6 hours after birth and is a potentially dangerous complication that increases the risk of short- and long-term damage to the central nervous system (CNS) and cardiovascular system [27].

Clinical symptoms of neonatal hypoglycemia are non-specific and reflect sympathetic nervous system reactions: sweating, pallor, irritability, tremor, irregular breathing, and tachycardia; when blood glucose levels drop further, apnea, feeding difficulties, hypotonia, convulsions, and CNS depression up to coma are observed [28]. Clinical manifestations of neonatal hypoglycemia do not necessarily correlate with blood glucose levels; some newborns have severe hypoglycemia that is asymptomatic, while others show symptoms at relatively higher blood glucose levels [29,30].

Currently, the universally accepted threshold value of blood glucose for treating hypoglycemia is 2.6 mmol/L, the safety and reliability of which have been proven by numerous studies [31]. Although the most common view is that the lower limit of normal blood glucose in newborns is 2.6 mmol/L, the Pediatric Endocrine Society of the USA recommends initiating treatment for all newborns, regardless of risk factors, at a glucose concentration of less than 2.8 mmol/L in the first 48 hours of life [32,33].

Other metabolic disorders in DF may include hypomagnesemia, hypocalcemia, and hypomagnesemia [34].

Newborns with DF have a characteristic appearance: macrosomia, "cushingoid" round face, abundant fat deposits, short neck, facial hypertrichosis, potbelly, hepatomegaly, hypotonia, and prominent fat folds on the limbs. Macrosomia can cause birth injuries, predominantly shoulder dystocia and brachial plexus injury. Macrosomia is clearly associated with increased neonatal morbidity; newborns with macrosomia are five times more likely to suffer from severe hypoglycemia and twice as likely to suffer from neonatal hyperbilirubinemia compared to the general population [6]. Transient tachypnea of the newborn occurs two to three times more frequently when the mother has DM [35].

It should be noted that pregnancy may proceed with intrauterine growth restriction and end with the birth of a small-for-gestational-age infant with poorly defined signs of diabetic fetopathy (DF).

Congenital heart defects in the fetus occur in 3–9% of cases when diabetes complicates pregnancy [36,37]. Other manifestations of cardiac pathology in DF may include signs of cardiomyopathy [38].

2. Diagnostics, medical indications and contraindications for diagnostic methods

Diagnostic criteria: The diagnosis is established based on a combination of data:

  1. anamnestic data (presence of DM or GDM in the mother or predisposing factors, e.g., obesity) [39],

  2. physical examination (see Section "Clinical Presentation"),

  3. laboratory tests (presence of transient hypoglycemia, hypocalcemia, hypomagnesemia, hyperbilirubinemia),

  4. instrumental examination (diagnosis of internal organ macrosomia, cardiomyopathy, exclusion of congenital developmental anomalies).

  5. conclusion of a subspecialist (endocrinologist, geneticist, etc.) if indicated.

2.1 Complaints and Anamnesis

  • If DF is suspected, it is recommended to review the maternal medical history to identify carbohydrate metabolism disorders during pregnancy [40].

Level of Recommendation CLevel of Evidence 5Level of Recommendation C (Level of Evidence — 5).

2.2 Physical Examination

See Section 1.6 "Clinical Presentation"

  • If DF is suspected, it is recommended to perform a general physical visual examination of the newborn [41].

Level of Recommendation CLevel of Evidence 3Level of Recommendation C (Level of Evidence — 3).

2.3 Laboratory Diagnostics

  • In a newborn infant with suspected DF, to confirm hypoglycemia and determine further management tactics, it is recommended to perform a blood glucose test 1–2 hours after birth, and then every 4 hours until the end of the 24th hour of life [42,43].

Level of Recommendation CLevel of Evidence 5Level of Recommendation C (Level of Evidence — 5).

Comments: Blood glucose monitoring can be completed earlier if the infant has been breastfed, has no pathological signs on clinical examination, and the results of two consecutive blood glucose measurements are normal.

  • In a newborn infant with suspected DF, to determine further management tactics, it is recommended to evaluate the hematocrit [43,44].

Level of Recommendation CLevel of Evidence 5Level of Recommendation C (Level of Evidence — 5).

  • In a newborn infant with suspected DF, to confirm electrolyte disturbances and determine further management tactics, it is recommended to test the total blood calcium level and the serum total magnesium level [42,43].

Level of Recommendation CLevel of Evidence 5 Level of Recommendation C (Level of Evidence — 5).

  • In a newborn infant with suspected DF who develops jaundice, to detect hyperbilirubinemia and determine further management tactics, it is recommended to test the total blood bilirubin level [43,45].

Level of Evidence CGrade of Recommendation 5Level of Clinical Effectiveness C (level of evidence – 5)

2.4 Instrumental Diagnostics

  • In a newborn born to a mother with DM or GDM, it is recommended to perform echocardiography to detect hypertrophic cardiomyopathy and possible minor congenital heart defects [41,43,46,47].

LeR CLoE 3Level of Recommendation C (Level of Evidence — 3)

2.5 Other Procedures

Not used.

3. Treatment, including drug and non-drug therapies, diet therapy, and pain management

3.1 Conservative Treatment

Feeding is the initial treatment for asymptomatic hypoglycemia.

  • In a newborn born to a mother with DM, it is recommended to initiate feeding within the first hour of life [43,48,49].

GCR CLEL 5Grade of Recommendation C (Level of Evidence - 5)

  • If the blood glucose level is less than 2.6 mmol/L in a newborn, it is recommended to administer other irrigation solutions (ATC code B05CX) – 10% dextrose** solution intravenously at a rate of 6 mg/kg per minute to correct hypoglycemia [50]. It is necessary to administer #dextrose** (ATC code B05CX01) 10% solution at a dose of 2 ml/kg intravenously, followed by continuous intravenous administration of 10% dextrose** (ATC code B05CX01) solution to prevent recurrence of hypoglycemia [43,51].

LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)

Comment. Intravenous administration of 20% dextrose** (ATC code B05CX) solution should be avoided, as it progresses hyperinsulinemia and hypoglycemia [43].

  • In a newborn, if the blood magnesium level drops below 0.6 mmol/L, electrolyte solutions (ATC code B05XA) – #magnesium sulfate** 20% solution administered intravenously at a dose of 0.1–0.3 ml/kg are recommended to treat hypomagnesemia [43].

LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)

  • In a newborn, if the blood calcium level drops below 1.8 mmol/L, calcium preparations (ATC code A12AA) – #calcium gluconate** 10% solution administered intravenously at a dose of 1–2 ml/kg, followed by oral administration of a maintenance dose of 50–60 mg/kg/day, are recommended to correct hypocalcemia [43,52].

GCR CLEL 5Grade of Recommendation C (Level of Evidence - 5)

3.2 Surgical Treatment

Not applicable

3.3 Other Treatment

The therapeutic and protective regimen involves creating optimal conditions for nursing newborns.

  • In a newborn with diagnosed hypertrophic cardiomyopathy or minor congenital heart defects according to echocardiography, an initial consultation (examination) by a pediatric cardiologist is recommended [43].

GCR CLEL 5Grade of Recommendation C (Level of Evidence - 5)

4. Medical Rehabilitation and Sanatorium-Resort Treatment

Not applicable.

5. Prevention and Dispensary Observation

  • To prevent the development of diabetic fetopathy in the newborn and improve outcomes, treatment of diabetes mellitus (DM) or gestational diabetes mellitus (GDM) in the mother is recommended [53–55].

LeR CLoE 4Level of Recommendation C (Level of Evidence — 4)

6. Organization of Medical Care

Treatment of a newborn born to a mother with DM is carried out in an inpatient setting.

The timing of discharge from the maternity hospital is determined by the health status of the mother and child. Before discharge, the neonatologist counsels the mother/parents on newborn care, breastfeeding, and the prevention of type 2 diabetes mellitus (T2DM) in the child. The discharge summary must indicate that the child's mother suffers from DM or GDM.

Indications for discharging a patient from a medical organization:

  1. Stable and satisfactory condition of the child;

  2. Stabilization of laboratory parameters;

  3. Absence of contraindications for discharge.

7. Additional Information

Inform pediatricians and adolescent therapists of the need to monitor carbohydrate metabolism, prevent obesity, and prevent T2DM in the child [40].

Criteria for Evaluating the Quality of Medical Care

Criteria for assessing the quality of medical care — Neonatal syndrome in an infant born to a mother with diabetes mellitus

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Appendix A1. Working Group Composition

  1. Aleksandrovsky Anatoly Vikentyevich – Candidate of Medical Sciences, Neonatologist 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, Member of the Russian Society of Neonatologists

  2. Balashova Ekaterina Nikolayevna – Candidate of Medical Sciences, Leading Researcher at the Prof. A.G. Antonov ICU, National Medical Research Center for Obstetrics, Gynecology and Perinatology Named after Academician V.I. Kulakov of the Russian Ministry of Health, Associate Professor at the Department of Neonatology, Institute of Professional Education, 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

  3. Baybarina Elena Nikolayevna – Doctor of Medical Sciences, 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, Member of the Council of the Russian Society of Neonatologists

  4. Bobrova Anna Mikhailovna – Neonatologist 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, Member of the Russian Society of Neonatologists

  5. Zubkov Viktor Vasilyevich – Doctor of Medical Sciences, Director of the Institute of Neonatology and Pediatrics, National Medical Research Center for Obstetrics, Gynecology and Perinatology Named after Academician V.I. Kulakov of the Russian Ministry of Health, Head of the Department of Neonatology, Institute of Professional Education, National Medical Research Center for Obstetrics, Gynecology and Perinatology Named after Academician V.I. Kulakov of the Russian Ministry of Health, Professor at the Department of Neonatology, N.F. Filatov Clinical Institute of Child 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

  6. Kukhartseva Marina Vyacheslavovna – 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, Member of the Russian Society of Neonatologists, Expert of the Russian Breastfeeding Association, Trainer for the WHO/UNICEF Breastfeeding Counselling Course

  7. Markelova Marina Mikhailovna – Neonatologist, 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, Member of the Russian Society of Neonatologists

  8. Narogan Marina Viktorovna – Doctor of Medical Sciences, Leading 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, Professor at the Department of Neonatology, N.F. Filatov Clinical Institute of Child 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

  9. Orlovskaya Irina Vladimirovna – Candidate of Medical Sciences, Senior Researcher, Head of Clinical Work at the Department of Neonatal and Premature Infant Pathology, Associate Professor at the Department of Neonatology, Institute of Professional Education, National Medical Research Center for Obstetrics, Gynecology and Perinatology Named after Academician V.I. Kulakov of the Russian Ministry of Health, Member of the Russian Society of Neonatologists

  10. Perepelkina Anna Evgenyevna – Neonatologist 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, Member of the Russian Society of Neonatologists

  11. Ryumina Irina Ivanovna – Doctor of Medical Sciences, Head of the Department of Neonatal and Premature Infant Pathology, Professor at the Department of Neonatology, Institute of Professional Education, National Medical Research Center for Obstetrics, Gynecology and Perinatology Named after Academician V.I. Kulakov of the Russian Ministry of Health, Honored Doctor of the Russian Federation, Member of the Russian Society of Neonatologists

  12. Khabibullina Azaliya Ilshatovna – Neonatologist 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, 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.

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 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 to these guidelines are presented as a preliminary draft for discussion. An updated version for broad discussion was posted on the websites of the Russian Society of Neonatologists (RSN) www.neonatology.pro and the Russian Association of Perinatal Medicine (RAPM) www.raspm.ru, as well as https://portalcr.minzdrav.gov.ru/, to allow all interested parties to participate in the discussion and improvement of 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:

1. Neonatologists

2. Anesthesiologists-intensivists

3. Pediatricians

4. Obstetricians-gynecologists

5. endocrinologists

6. general practitioners

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. Rating scale for 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. Rating scale for 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:

  1. Federal Law No. 323-FZ "On the Fundamentals of Protecting the Health of Citizens in the Russian Federation" dated November 21, 2011.

  2. Order of the Russian Ministry of Health No. 203n of May 10, 2017, "On Approval of Criteria for Assessing the Quality of Medical Care."

  3. International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10) (World Health Organization), 2019 version.

  4. Order of the Russian Ministry of Health No. 804n dated October 13, 2017 (as amended on September 24, 2020, with rev. of 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).

  5. 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).

  6. 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 drugs, as well as lists of drugs for medical use and the minimum assortment of drugs required for medical care".

  7. State Register of Medicinal Products: https://grls.rosminzdrav.ru

Appendix B. Physician Action Algorithms

Appendix B. Physician action algorithms — Neonatal syndrome in an infant born to a mother with diabetes mellitus

Appendix C. Patient Information

Diabetic fetopathy (DF) develops when a pregnant woman suffers from diabetes mellitus (DM) or gestational diabetes mellitus (GDM). The mechanism of diabetic fetopathy involves the effect of maternal hyperglycemia on the fetus, leading to increased insulin production by the fetus, which in turn causes excessive fat and glycogen deposition (primarily in the heart and liver), and other metabolic disorders. Heart and liver damage, as well as pronounced jaundice, cannot be ruled out. It is important to know that the better controlled the mother's diabetes is, the less pronounced the diabetic fetopathy in the child. After birth, infants with DF often develop hypoglycemia, i.e., low blood glucose levels, which is dangerous for the baby. Therefore, newborn blood glucose levels are monitored, and if necessary, dextrose** (ATX code V05CX) is administered intravenously. Usually, the child's glucose levels normalize within a few days.

It should be noted that a child born to a mother with DM or GDM has an increased risk of developing type 2 DM in adulthood. To prevent this, it is necessary to prevent excess weight and obesity in the child from the earliest age possible. To achieve this, it is very important to ensure breastfeeding; ideally, the baby should receive only mother's breast milk until 6 months of age, and breastfeeding overall should continue until 1–1.5 years. Subsequently, weight control, a proper diet without an excess of high-calorie foods, and sufficient physical activity are recommended.

Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools

Not applicable.

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