List of Abbreviations
AR – anti-reflux (formula)
CMPA – cow's milk protein allergy
CD – congenital defect (congenital malformation)
IUI – intrauterine infection
BF – breastfeeding
EHF – extensive protein hydrolysate
GER – gastroesophageal reflux
GERD – gastroesophageal reflux disease
Du – duodenum
GI – gastrointestinal tract
FF – formula feeding
PPI – proton pump inhibitors
IEM – inherited inborn errors of metabolism
LES – lower esophageal sphincter
NSG – neurosonography
RS – rumination syndrome
RCTs – randomized controlled trials
HH – hiatal hernia
SMF – standard milk formula
MM – mucous membrane
US – ultrasound examination
US – ultrasonography
EGD – esophagogastroduodenoscopy
DSM-5 – Diagnostic and Statistical Manual of Mental Disorders, 5th Edition
ESPGHAN (European Society of Pediatric Gastroenterology, Hepatology and Nutrition)
HRM – high-resolution manometry
VFSS – videofluoroscopic swallow studies
Terms and Definitions
Regurgitation is the retrograde passage (reflux) of gastric contents beyond the organ — into the pharynx, oral cavity, or out of the oral cavity.
Rumination syndrome (RS) is characterized by repeated, effortless regurgitation of food during or shortly after meals, followed by rechewing, swallowing, or spitting out of the food.
Gastroesophageal reflux (GER) is the retrograde flow of gastric contents into the esophagus, accompanied by regurgitation and/or vomiting.
Gastroesophageal reflux disease (GERD) is a pathological condition characterized by the reflux of gastric contents into the esophagus (gastroesophageal reflux), leading to troublesome symptoms and/or complications.
1. Brief information on the disease or condition
1.1 Definition of the disease or condition
Rumination syndrome is a functional gastrointestinal (GI) disorder characterized by repeated, effortless regurgitation—the return of recently swallowed food into the mouth, followed by another episode of chewing and then swallowing, or the expulsion of a food bolus that is usually tasteless, although it may be sour or bitter because it occurs within minutes after a meal. RS is frequently misdiagnosed as GERD or vomiting, resulting in unnecessary diagnostic tests and treatments [1–5].
Regurgitation is a symptom specific to newborns and infants in their first year of life. During regurgitation, the backward flow of gastric contents occurs passively without tension in the abdominal wall and diaphragm. Unlike vomiting, regurgitation is not accompanied by autonomic responses. In most cases, RS and regurgitation are mild, self-limiting conditions that resolve spontaneously by 12–15 months of age; nevertheless, they can cause significant distress for parents due to increased parental stress and a potential impact on quality of life [1,3,4,6].
1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)
Regurgitation is physiological and associated with the sucking mechanism—it facilitates the release of excess swallowed air from the stomach. By the 6th month of life, the development of the lower esophageal sphincter (LES) is complete, and symptoms of its dysfunction at an older age may be considered pathological.
Causes of regurgitation/rumination in children [7–17]:
1) high intra-abdominal pressure due to tight swaddling, constipation, increased gas production, prolonged crying, improper feeding technique (aerophagia), or overfeeding;
2) vegetative-visceral disturbance syndrome in cerebral ischemia (pylorospasm), gastrointestinal dysmotility, and hereditary metabolic disorders;
3) low gestational age (<32 weeks);
4) low birth weight (<1.5 kg);
5) delivery by Cesarean section;
6) early transition to formula feeding;
7) use of antibiotics in both the mother and the newborn;
8) inappropriate use of probiotics;
9) allergy (intolerance) to cow's milk protein;
10) duration of neonatal hospitalization exceeding 7 days;
11) maternal harmful habits (including a history of smoking);
12) RS is typically characterized by emotional neglect (a habitual family interaction style where parents fail to notice and inadequately respond to children's emotions and emotional needs) [18].
The high frequency of regurgitation in newborns during their first month of life is due to the anatomical features of the upper digestive tract [7,8]:
the esophagus is wide and funnel-shaped, with the funnel opening directed upward;
the muscular layer of the esophagus is poorly developed, and anatomical constrictions are indistinct;
the ligamentous apparatus is loose and delicate, and the crura of the diaphragm loosely embrace the esophagus;
the esophagus joins the stomach at a right angle;
the stomach is spherical in shape;
the pyloric part of the stomach is well developed, whereas the cardia is poorly expressed;
the high-pressure zone above the lower esophageal sphincter is virtually absent;
immaturity of the neurohumoral regulation of the sphincter apparatus and gastrointestinal motility during the first years of a child's life.
The pathophysiology of rumination syndrome is not fully understood. A key mechanism may be an imperceptible postprandial contraction of the abdominal wall. The retrograde movement of gastric contents into the oral cavity is achieved through the simultaneous combination of increased intra-abdominal pressure and negative intrathoracic pressure [19–22].
1.3 Epidemiology of the Disease or Condition
The true prevalence of regurgitation in newborns is unknown. Using the Rome IV criteria, and taking into account age, ethnicity, birth weight, gestational age, and weaning age, daily regurgitation occurs in 10.5% to 86.9% of infants [8,23–26]. When Rome IV criteria are not strictly applied, the frequency of regurgitation approaches nearly 100% of newborns [27].
According to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), the prevalence of RS, particularly among newborns, has not been thoroughly investigated because different diagnostic criteria are used depending on the clinical situation. According to some data, it ranges from 0.8% to 10.6% in community samples [28–33].
1.4 Features of Coding the Disease or Condition
P92.1 Neonatal regurgitation and rumination
1.5 Classification of the disease or condition
In accordance with the Rome IV consensus, regurgitation/rumination is classified as a "functional gastroduodenal disorder" [3]. According to the criteria adopted by the American Psychiatric Association in 2022 (DSM-5), regurgitation/rumination falls under the category of "feeding and eating disorders" [33].
1.6 Clinical presentation of the disease or condition
The clinical presentation of regurgitation/rumination is variable and non-specific.
Characteristic symptoms of rumination disorder include regular regurgitation and repeated chewing of food. During regurgitation, children make specific movements: they tense their back and abdominal muscles, arch their back, throw their head back, and make sucking or smacking motions. The most common parental complaint is frequent vomiting. The physical mechanism generating regurgitation/rumination phenomena depends on an involuntary process that alters intra-abdominal and intrathoracic pressures while accompanied by a permissive esophagogastric junction [34].
The main clinical characteristics include [19]:
regurgitation immediately after food intake;
the effortlessly regurgitated material resembles swallowed food;
the regurgitated material is either spat out or swallowed again.
Frequent and profuse regurgitation can lead to significant weight loss and dehydration. The severity of the regurgitation syndrome is assessed using a five-point scale according to the ESPGHAN expert group recommendations (Table 1).
Table 1. Regurgitation intensity rating scale [35].
Quantity points | Characteristic |
|---|---|
0 | No regurgitation |
1 | More than 5 regurgitation episodes per day with a volume of no more than 3 ml |
2 | More than 5 regurgitation episodes per day with a volume greater than 3 ml |
3 | More than 5 regurgitation episodes per day with a volume up to half of a single feeding, occurring no more frequently than in half of the feedings |
4 | Small-volume regurgitation for 30 minutes or more after every feeding |
5 | Regurgitation of more than half the total volume of a single feeding in at least half of the feedings |
2. Diagnostics, medical indications and contraindications for diagnostic methods
Criteria for establishing the diagnosis/condition:
To establish a clinical diagnosis of neonatal regurgitation/rumination, the following are required [1–4,7,8,10–12,34]:
1) a thorough perinatal history taking;
2) a physical examination assessing physical development and identifying red flag symptoms that indicate organic pathology.
Alarm symptoms ("red flags") [2–4,6–8]:
onset of regurgitation in the 1st–2nd week of life;
lethargy, fever;
retching with food refusal;
projectile vomiting;
presence of blood or bile in the vomitus;
aspiration of gastric contents;
prolonged cough, rales, wheezing;
delayed physical growth rate;
difficulty during feeding or the process of swallowing food (dysphagia, odynophagia);
incorrect body position, specifically a dystonic neck posture—Sandifer syndrome (a rare disorder characterized by episodes of paroxysmal torticollis, sometimes with spastic nodding head movements occurring against the background of GERD); this syndrome represents a combination of GERD with spastic torticollis and dystonic body movements, with or without a hiatal hernia;
excessive irritability/pain;
bulging fontanelle;
rapid rate of head circumference gain;
seizures;
weight loss;
dysuria;
defecation disorders (diarrhea/constipation);
disorders up to the development of apnea and sudden infant death syndrome.
Comment. When taking a medical history, great attention is paid to:
1) the course of pregnancy (toxicosis, gestosis, threatened miscarriage, edema of pregnant women, anemia, preeclampsia, exacerbation of chronic pathology, etc.) and labor (rapid labor, uterine inertia, operative delivery, etc.), which can cause fetal hypoxia and contribute to increased regurgitation in the infant;
2) a thorough genealogical history, as many diseases are hereditary (e.g., pyloric stenosis is a hereditary pathology in 15% of cases). There is also a genetic predisposition to the occurrence of hiatal hernias [36];
3) the time of onset of the first regurgitation episodes;
4) the routine, method, duration, and volume of each feeding; the type of formula used in formula feeding, and the mother's diet;
5) the nature of regurgitation (e.g., nocturnal, immediately after eating, some time after eating) and the composition of regurgitant masses: curdled or uncurdled;
6) family history and potential environmental triggers (including family psychosocial status and factors such as parental tobacco use);
7) the use of pharmacological and dietary interventions in both the infant and the mother [4].
Despite the fact that regurgitation/rumination in newborns is often benign, some infants with red flag symptoms require further evaluation.
A more challenging subgroup of patients consists of children who are fussy, cry, and arch their backs, have persistent regurgitation, but otherwise feel well. In this subgroup of children, families often exert strong pressure on the physician to initiate AR therapy or perform diagnostic testing due to the perceived severity of the symptoms [4].
In the absence of warning signs, diagnostic tests and/or treatments, including acid suppression, are NOT required unless the symptoms affect feeding, growth, or the achievement of developmental milestones [4,35].
The main symptom of rumination syndrome (RS) is effortless, recurrent regurgitation of recently ingested food. Aside from this main feature, there is no clear consensus among diagnostic recommendations regarding RS criteria, mainly due to a lack of studies to substantiate diagnostic guidelines. Due to insufficient awareness of RS, this condition is often misdiagnosed or missed [37–39].
According to the Rome criteria, establishing a diagnosis of RS requires the presence of symptoms for at least two months. These include [3,10]:
- repetitive contractions of the abdominal muscles, diaphragm, and tongue;
- effortless regurgitation of gastric contents, which are either expelled from the mouth or re-chewed and re-swallowed;
- age of onset between 3 and 8 months;
- infants do not respond to treatment for GERD and regurgitation;
- rumination does not occur during sleep or when the infant is interacting with people in the surrounding environment [40].
2.1 Complaints and Anamnesis
In the presence of regurgitation/rumination in a newborn, it is recommended to:
- review the maternal history to identify risk factors;
- review the obstetric history and the course of the early neonatal period in the newborn;
- note the time of onset and the dynamics of clinical symptoms [1-4,7-13,34].
GPP CLOE 4Grade of Recommendation C (Level of Evidence – 4).
Comments: see Section 1.2 "Etiology and Pathogenesis of the Disease".
When reviewing the history of a newborn with regurgitation/rumination, it should be kept in mind that the main risk factors are prematurity, severe asphyxia, a stressful family situation, dysbiosis, and iatrogenic interventions leading to a disrupted microbiocenosis [7–13].
2.2 Physical Examination
A newborn infant suffering from regurgitation/rumination is recommended to undergo a physical examination by a pediatrician with the identification of red flag symptoms, as well as anthropometry with the assessment of weight and height parameters [1–4,7–12,34].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: see section 2. "Diagnostics of the disease or condition (group of diseases or conditions)", medical indications and contraindications for the use of diagnostic methods [2–4,7,8,10,34,36]. Due to the lack of pathognomonic symptoms, it is primarily necessary to pay attention to the presence of red flag symptoms; if identified, organic pathology must be ruled out (infection, congenital malformations, metabolic disorders, GERD, etc.).
2.3 Laboratory Diagnostics
It is recommended that newborn infants with regurgitation/rumination, in the presence of red flag symptoms, undergo a complete blood count (CBC) with differential in order to rule out/confirm an infectious process and hemostatic disorders of both prenatal and postnatal origin [42,71,72].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: if blood parameters are altered, an in-depth examination is recommended in accordance with the underlying causes of the aforementioned conditions (diseases).
It is recommended that newborn infants with regurgitation/rumination, in the presence of red flag symptoms and poor weight gain/weight loss, undergo an acid-base balance (ABB) and blood gas test, determination of blood lactate and blood ammonia levels in order to guide further diagnostic workup, with the aim of identifying metabolic changes arising from metabolic disorders in inherited metabolic diseases (IMDs) and infectious processes [73,74].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: if the aforementioned parameters are altered, an in-depth examination is recommended.
2.4 Instrumental Diagnostics
It is recommended that newborns suffering from regurgitation/rumination, in the presence of profuse, persistent regurgitation, undergo a comprehensive ultrasound examination of the abdominal organs, as well as an ultrasound of the kidneys and adrenal glands, for the purpose of diagnosing conditions such as pyloric stenosis, hydronephrosis, ureteral obstruction, gallbladder stones, ovarian torsion, sliding hiatal hernia (SHH), as well as determining the length and position of the lower esophageal sphincter (LES) relative to the diaphragm, and the magnitude of the esophagogastric His angle [75,76,77,78].
GPP BLOE 3Grade of Recommendation B (Level of Evidence – 3).
It is recommended that newborn infants with regurgitation/rumination, in the presence of persistent, profuse regurgitation debuting in the first week of life and unresponsive to conventional treatments, undergo contrast fluoroscopy of the esophagus to rule out congenital malformations (sliding hiatal hernia, malrotation, pyloric stenosis, esophageal web/membrane, duodenal stenosis, antral web, esophageal narrowing, Schatzki rings, achalasia, esophageal strictures, and external esophageal lesions) [78,79,80,81,82].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: the barium study of the esophagus and stomach is performed in the anteroposterior and lateral projections and in the Trendelenburg position with mild abdominal compression. The study assesses barium transit, esophageal diameter, contours, wall elasticity, pathological stenoses, ampullary dilations, peristalsis, and mucosal relief. Disadvantages of the method include the fact that radiography does not always allow small hernias to be detected and delivers a high radiation dose.
If congenital gastrointestinal anomalies or inflammatory gastrointestinal diseases are suspected, newborn infants with regurgitation/rumination are recommended to undergo esophagogastroduodenoscopy (EGD) to determine the severity of esophageal and gastric mucosal damage, identify complications, and perform differential diagnosis [78,82,83].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: during the procedure, the condition of the esophageal mucosa is assessed, which is especially important in the presence of warning symptoms (hematemesis, dysphagia, delayed weight gain). The procedure allows for the diagnosis of a range of congenital esophageal anomalies, as well as acquired inflammatory and non-inflammatory diseases. EGD under general anesthesia can be considered a safe procedure in pediatric patients [4].
It is recommended to perform manometry—esophageal manometry (high-resolution, with or without impedance)—in infants with regurgitation/rumination who do not respond to ongoing therapy, or when congenital neuromuscular diseases or esophageal malformations are suspected, in order to assess luminal pressure activity [4,19,34,47–51].
GCR ALoE 2Grade of Recommendation A (Level of Evidence – 2).
Comments: currently, high-resolution manometry (HRM) is performed to assess esophageal motility, providing a more detailed view of luminal pressure activity than conventional manometry. Based on pediatric studies, HRM may be valuable for evaluating "R-waves" and retrograde bolus flow to diagnose rumination mimicking refractory reflux symptoms [19,34,47–51]. Performing manometric studies depends on the technical capabilities of the medical organization.
2.5 Other Procedures
Diagnostics of diseases associated with regurgitation and vomiting are performed according to indications [52].
3. Treatment, including drug and non-drug therapies, diet therapy, and pain management
Therapeutic management for regurgitation in newborns includes a set of non-pharmacological interventions—primarily the normalization of lifestyle, daily routine, and nutrition—as well as conservative therapy. The choice of treatment method or their combination depends on the cause, severity, and potential complications [4,52].
3.1 Conservative Treatment
3.1.1. Postural therapy
It is recommended to use postural correction in newborns with regurgitation, i.e., treatment by changing body position: hold the infant at an angle of 45–60° during feeding, which prevents regurgitation and aerophagia. At night, it is advisable to elevate the head of the crib by 10–15 cm [4,6–8].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: the infant should be kept in an upright position after feeding for at least 20–30 minutes (with the head elevated). Placing a newborn in a forced position during sleep (elevated head of the bed, especially a horizontal prone position) is not recommended due to the high risk of sudden infant death syndrome (SIDS).
3.1.2. Dietary therapy
Recommended in newborn infants with regurgitation to use dietary correction taking into account the type of feeding [4,6-8,52].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: for breastfeeding, it is recommended to create a calm environment for the nursing mother to maintain lactation, normalize the feeding schedule to avoid overfeeding, and monitor proper latching to prevent aerophagia.
For formula-fed newborn infants with regurgitation, it is recommended to increase the frequency of feedings while decreasing the single volume of the infant formula given [6–8].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
In the absence of data regarding cow's milk protein (CMP) intolerance, it is recommended to switch a newborn infant with regurgitation to a specialized food product—an anti-regurgitation (AR) formula, the viscosity of which is increased by adding a thickener [4,6–8].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: two types of polysaccharides are used as thickeners: non-digestible (locust bean gum) and digestible (modified starches). Gum or starch (rice, corn, or potato) included in AR formulas binds fluid and swells upon entering the child's stomach, thereby making the formula thicker, which prevents the backflow of contents into the esophagus and oral cavity. AR products are introduced into the child's diet gradually, at every feeding. The volume of the therapeutic formula is selected individually until regurgitation ceases. The effect of starch-enriched AR formula occurs later compared to gum-containing AR formula. AR products are recommended for children with both normal stools and a tendency toward loose stools [53,54]. Starch-containing formulas are recommended to be prescribed in the full daily volume. Despite the high clinical efficacy of AR products, they should not be used uncontrollably as an alternative to standard infant formula (SIF). AR formulas are used at a specific stage of regurgitation syndrome treatment, according to indications. The duration of their use is individual, sometimes quite long (up to 2–3 months), and only after achieving a sustained therapeutic effect should the infant be switched to SIF [3,6–8,53,54].
It is recommended to use extensively hydrolyzed protein (EHP) or amino acid-based formulas in a newborn infant with regurgitation if dietary correction using an AR formula is ineffective within 2–4 weeks; these can reduce regurgitation episodes in infants with cow's milk protein allergy [6–8].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: formulas based on EHP are indicated when the infant exhibits other symptoms pointing to atopic (allergic) diseases [4,6-8]. The absence of clinical improvement within 2–4 weeks indicates the ineffectiveness of the chosen dietary therapy tactic. If a positive effect is achieved, it is recommended to continue feeding the formula up to 12 months, but for at least 6 months [43,57].
3.1.3. Pharmacotherapy
Not applicable.
3.2 Surgical Treatment
Not applicable.
3.3 Other Treatment
Not applicable.
4. Medical Rehabilitation and Sanatorium-Resort Treatment
Not applicable.
5. Prevention and Dispensary Observation
It is recommended to carry out measures aimed at preventing etiological factors—such as perinatal hypoxia and asphyxia—to prevent regurgitation/rumination in newborns; promote natural childbirth and breastfeeding; and create a favorable family environment as well as a benevolent, attentive attitude toward the newborn [7,8,10–14].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
It is recommended that infants with regurgitation/rumination be monitored by a pediatrician who monitors physical development indicators, conducts explanatory talks and provides psychological support to parents, performs postural correction, prescribes breastfeeding diet therapy based on the rational nutrition of nursing mothers, and prescribes mixed and formula feeding diet therapy based on the use of thickened formulas [7,8,84].
GPP CLOE 4Grade of Recommendation C (Level of Evidence – 4).
6. Organization of Medical Care
For the prevention, timely diagnosis, and selection of further management tactics for newborns with rumination/regurgitation, medical care is provided at primary care medical institutions of the first level (providing basic and specialized primary health care to the population), second level (medical institutions providing medical care in certain specialties), and third level, ensuring specialized and high-tech medical care. This includes consultations by specialists (neonatologist, neurologist, gastroenterologist, allergist-immunologist, pediatric surgeon), examinations, and therapy.
Indications for hospitalization in a medical organization for newborns with rumination/regurgitation [1,8]:
- persistent regurgitation refractory to correction;
- presence of persistent, pronounced red flags (regurgitation alternating with vomiting; admixture of blood and/or bile in the regurgitate) leading to significant weight loss, symptoms of dehydration, electrolyte and metabolic disorders, as well as respiratory symptoms associated with regurgitation (laryngospasm, bronchospasm, aphonia, cough).
Indications for discharge from the medical organization for newborns with rumination/regurgitation:
- resolution of red flags,
- stabilization of the condition,
- exclusion of organic etiology (surgical, infectious, endocrine, metabolic, allergic, neurological, etc.).
After discharge from the hospital, children are subject to outpatient follow-up by a pediatrician and other specialists depending on the identified etiology (neurologist, gastroenterologist, endocrinologist, surgeon, geneticist, etc.).
The decision on the need for re-hospitalization is made by the pediatrician or a subspecialist in each specific case.
Issues concerning the rehabilitation of infants with regurgitation/rumination are decided by the pediatrician on an individual basis.
7. Additional Information
The prognosis for regurgitation/rumination is predominantly favorable. However, frequent regurgitation in infancy may have long-term health consequences, increasing the risk of heartburn, vomiting, and acid regurgitation [70].
Criteria for Evaluating the Quality of Medical Care
References
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Appendix A1. Working Group Composition
Ivanov Dmitry Olegovich – Doctor of Medical Sciences, Professor, Rector of the Saint Petersburg State Pediatric Medical University of the Russian Ministry of Health, Head of the Department of Neonatology with Courses in Neurology and Obstetrics-Gynecology of the Faculty of Postgraduate Education of the Saint Petersburg State Pediatric Medical University of the Russian Ministry of Health, Chief freelance neonatologist of the Ministry of Health of the 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, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after 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 V.I. Kulakov of the Russian Ministry of Health, Member of the Council of the Russian Society of Neonatologists.
Bogdanova Natalia Mikhailovna – Candidate of Medical Sciences, Associate Professor at the Department of Propaedeutics of Children's Diseases with a Course of General Childcare, Saint Petersburg State Pediatric Medical University of the Russian Ministry of Health.
Zavyalova Anna Nikitishna – Doctor of Medical Sciences, Professor at the Department of Propaedeutics of Children's Diseases with a Course of General Childcare, Saint Petersburg State Pediatric Medical University of the Russian Ministry of Health.
Laptiev Sergey Aleksandrovich – Candidate of Medical Sciences, Associate Professor at the Department of General and Medical Genetics, Saint Petersburg State Pediatric Medical University of the Russian Ministry of Health.
Valeria P. Novikova – Doctor of Medical Sciences, Professor, Head of the Department of Propaedeutics of Children's Diseases with a Course of General Nursing, St. Petersburg State Pediatric Medical University of the Russian Ministry of Health, Head of the Laboratory of Medical and Social Problems in Pediatrics, National Medical Research Center, St. Petersburg State Pediatric Medical University of the Russian Ministry of Health, Member of the Russian Society of Pediatric Gastroenterologists, Hepatologists and Nutritionists.
Larisa A. Fedorova – Candidate of Medical Sciences, Associate Professor at the Department of Neonatology with Courses of Neurology and Obstetrics and Gynecology, Faculty of Postgraduate Education, St. Petersburg State Pediatric Medical University of the Russian Ministry of Health.
Anatoly I. Khavkin – Doctor of Medical Sciences, Professor, Head of the A.V. Mazurin Department of Gastroenterology and Dietetics, Head of the Moscow Regional Center for Pediatric Gastroenterology and Hepatology at the Research Clinical Institute of Childhood of the Ministry of Health of the Moscow Region; Professor at the Department of Pediatrics with a Course of Pediatric Surgical Diseases, Medical Institute, Belgorod State National Research University, Chairman of the Russian Society of Pediatric Gastroenterologists, Hepatologists and Nutritionists, Member of the Union of Pediatricians of Russia.
There is no conflict of interest.
Appendix A2. Methodology for Developing Clinical Guidelines
Methods used for evidence collection/selection: electronic database search.
Description of methods used for evidence collection/selection: the evidence base for the guidelines 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 32 years.
Methods used to assess the quality and strength of evidence:
- expert consensus;
- grading of significance according to 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 evidence analysis:
- 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 recommendation 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 in a preliminary version. The updated version for wide discussion was posted on the website of the Russian Society of Neonatologists (RSN) www.neonatology.pro and https://portalcr.minzdrav.gov.ru/ so that all interested parties could take part 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:
neonatologists
pediatricians
gastroenterologists
general practitioners (family physicians)
Table 1. Scale for assessing the 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 (as amended on December 28, 2024) "On the Fundamentals of Protecting the Health of Citizens in the Russian Federation" (with rev. and add., effective March 1, 2025).
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 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."
Order of the Russian Ministry of Health dated April 17, 2025 No. 222n "On Approval of the Procedure for Providing Medical Care in the Profile 'Neonatology'" (Registered with the Russian Ministry of Justice on June 2, 2025, No. 82516).
Order of the Government of the Russian Federation dated October 12, 2019 No. 2406-r (as amended on April 16, 2024) <On Approval of the List of Vital and Essential Medicines, as well as Lists of Medicinal Products for Medical Use and the Minimum Assortment of Medicinal Products Necessary for the Provision of Medical Care>.
Appendix B. Physician Action Algorithms
Appendix C. Patient Information
Regurgitation in newborns is a functional digestive disorder resulting from the anatomical and physiological immaturity of the upper gastrointestinal tract.
Predisposing factors include premature birth, improper feeding technique, a negative psychological climate in the family, etc.
To diagnose regurgitation in newborns, history taking and physical examination data are necessary; according to indications, in the presence of red flags, to exclude organic pathology, pHmetry, abdominal ultrasound, and gastrointestinal radiography are recommended.
Despite a benign course, regurgitation often negatively impacts the family's quality of life. Therefore, to reduce maternal anxiety, a pediatrician (neonatologist) should explain the nature of the child's problem in an accessible manner during a consultation; provide clear recommendations on infant care, positioning therapy, and feeding rules, depending on the type of feeding.
Proper feeding is of key importance regardless of whether the child is breastfed or formula-fed, because infants with regurgitation are often overfed (causing regurgitation) and sometimes underfed (as a consequence of regurgitation). Feeding technique and volumes are extremely important to prevent regurgitation. If the infant receives mother's milk, the main instructions will concern the mother's diet.
It must be emphasized that the presence of regurgitation is almost never a reason to stop breastfeeding.
For formula feeding, first, more frequent feedings in smaller single volumes of the product should be offered, which can reduce the number of regurgitation episodes. If ineffective, the child should be switched to an anti-regurgitation (AR) formula. A commercial, readily available AR formula is preferable to independently thickening the product at home due to the negative impact of extra calories and changes in formula osmolarity (e.g., adding cereal or starch to breast milk or formula). There are also no grounds to recommend mixing formula with breast milk or mixing different formulas.
Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools
Not applicable.