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    Rome IV Diagnostic Criteria for Infant Regurgitation

    Official Rome IV criteria for the diagnosis of infant regurgitation.


    Use in infants 3 weeks to 12 months with regurgitation for at least 3 weeks.

    Patients with any of the following alarm features should be evaluated clinically for other diagnoses:

    • Excessive irritability.

    • Onset <3 weeks, > 6 months or persistence >12 months of age.

    • Retching and/or persistent forceful vomiting.

    • Bilious or nocturnal vomiting.

    • Hematemesis.

    • Aspiration.

    • Respiratory symptoms (wheezing, stridor, cough, hoarseness).

    • Apnea.

    • BRUE (Brief Resolved Unexplained Event).

    • Weight loss or failure to thrive.

    • Feeding or swallowing difficulties including food refusal.

    • Abnormal neurologic exam, posturin or seizures

    • Dystonic neck posturing (Sandifer syndrome).

    • Chronic diarrhea or constipation.

    • Rectal bleeding.

    • Macro or Microcephaly.

    • Bulging fontanelle.

    • Hepatosplenomegaly.

    • Abdominal tenderness or distension.

    • Documented or suspected genetic/metabolic syndrome.

    • Fever.

    • Lethargy.

    When to Use
    Why Use

    Infants presenting with regurgitation who are otherwise growing and thriving normally. The diagnosis of infant regurgitation should be made by clinical history, positive symptom criteria and physical examination. Laboratory or imaging studies are typically not needed in the absence of any alarm features.

    • Infant regurgitation is the most common disorder of the gut-brain interaction in the first year of life. It is defined as the involuntary return or reflux of previously swallowed food or secretions out of the stomach into and/or out of the mouth. 

    • Infant regurgitation typically peaks at age 4 months, starts improving at 6 months and resolves by 12 months in 90% of infants.

    • If the infant is feeding well, gaining weight and is not excessively irritable, reassurance is the most important intervention. 

    • There is no benefit of PPI treatment for infants with infant regurgitation. 

    • When the regurgitation of gastric contents causes complications such as tissue damage or inflammation (e.g. esophagitis, aspiration, feeding and swallowing problems, failure to thrive, etc), it is termed gastroesophageal reflux disease (GERD).  Differentiating infant regurgitation from GERD can be challenging as symptoms overlap. Isolated symptoms of fussiness, crying and arching in an infant who is thriving and developing normally are unlikely related to GERD and care should be taken to avoid its overdiagnosis and unnecessary treatment. 

    • Patients with prematurity, developmental delay, congenital abnormalities of the oropharynx, chest, lungs, CNS, heart, or GI tract are at increased risk for GERD. Further, evidence of failure to thrive, food refusal, hematemesis, occult or frank blood in the stool, neck posturing, and respiratory symptoms may suggest GERD.  

    • It is important to distinguish regurgitation from vomiting because the latter can be a symptom of underlying anatomic abnormalities, metabolic, infectious or neurologic conditions. 

    • In case of a strong family history of food allergy, excessive irritability and/or presence of blood in the stool, milk protein allergy should be considered and treated accordingly. Allergies can occur in both formula fed infants and breastfed infants through exposure to dietary antigens in the breast milk.

    • Used to establish the diagnosis of infant regurgitation in infants who present with significant regurgitation.

    • Making a diagnosis will help provide reassurance, anticipatory guidance, avoid unnecessary doctor visits, testing and reflux treatment.

    Must have the following:

    For an otherwise healthy infant 3 weeks to 12 months of age

    Diagnostic Result:

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    Next Steps
    Creator Insights
    Dr. Douglas Drossman

    About the Creator

    Douglas Drossman, MD, is professor emeritus of medicine and psychiatry at the University of North Carolina School of Medicine. He is founder, President Emeritus and Chief of Operations of the Rome Foundation. He is also the founder of the Drossman Center for the Education and Practice of Biopsychosocial Care and Drossman Consulting, LLC. Dr. Drossman has written over 500 articles and book chapters, has published two books, a GI procedure manual and a textbook of functional GI disorders (Rome I-IV), and serves on six editorial and advisory boards.

    To view Dr. Douglas Drossman's publications, visit PubMed

    Dr. Lin Chang

    About the Creator

    Lin Chang, MD is responsible for the oversight and coordination of the Rome IV calculators on MDCalc. She is a Professor of Medicine at the Vatche and Tamar Manoukian Division of Digestive Diseases at UCLA and is a member of the Rome Foundation Board of Directors.

    To view Dr. Lin Chang's publications, visit PubMed

    The Rome Foundation

    About the Creator

    The Rome Foundation is an independent not for profit 501(c) 3 organization that provides support for activities designed to create scientific data and educational information to assist in the diagnosis and treatment of Disorders of Gut-Brain Interaction (DGBI), also known as functional gastrointestinal (GI) disorders. Their mission is to improve the lives of people with DGBI. Over the last 3 decades, the Rome organization has sought to legitimize and update our knowledge of the DGBIs. This has been accomplished by bringing together scientists and clinicians from around the world to classify and critically appraise the science of GI function and dysfunction. This knowledge permits clinical scientists to make recommendations for diagnosis and treatment that can be applied in research and clinical practice. Diagnosis is based on the use of symptom-based criteria which are used in clinical trials and daily practice. The list of Rome IV categories and the Chair and Co-Chair of each chapter committee are listed below.

    Committees Chair Co-Chair
    Esophageal Disorders Ronnie Fass, MD John Pandolfino, MD
    Gastroduodenal Disorders Nicholas J. Talley, MD, PhD, FRACP Vincenzo Stanghellini, MD
    Bowel Disorders Fermin Mearin, MD Brian Lacy, MD, PhD
    Gallbladder and Sphincter of Oddi Disorders Grace Elta, MD Peter Cotton, MD
    Centrally Mediated Disorders of Gastrointestinal Pain Peter J. Whorwell, MD Laurie Keefer, PhD
    Anorectal Disorders Adil E. Bharucha, MD, MBBS Satish S. C. Rao, MD, PhD, FRCP
    Childhood Functional Gastrointestinal Disorders: Neonate/Toddler Sam Nurko, MD Marc A. Benninga, MD
    Childhood Functional Gastrointestinal Disorders: Child/Adolescent Carlo Di Lorenzo, MD Jeffrey S. Hyams, MD

    Rome IV Diagnostic Criteria Chapters, Chairs and Co-Chairs

    Rome IV Editorial Board: Douglas A. Drossman, MD, Senior Editor, Lin Chang, MD, William D. Chey, MD, John Kellow, MD, Jan Tack, MD, PhD, and William E. Whitehead, PhD.

    To view The Rome Foundation's publications, visit PubMed

    Content Contributors
    • Beate Beinvogl, MD, MPH
    Reviewed By
    • Samuel Nurko, MD, MPH
    About the Creator
    Dr. Douglas Drossman
    Dr. Lin Chang
    The Rome Foundation
    Content Contributors
    • Beate Beinvogl, MD, MPH
    Reviewed By
    • Samuel Nurko, MD, MPH