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    Rome IV Diagnostic Criteria for Infant Colic

    Official Rome IV criteria for the diagnosis of infant colic.


    Use in infants < 5 months with symptoms of infant colic such as recurrent and prolonged, unsoothable episodes of crying, fussing, or irritability that occur without obvious cause.

    Patients with any of the following alarm features must be evaluated clinically for other anatomic, metabolic, infectious, neurological, or behavioral conditions:

    • Extreme or high-pitched cry.

    • Symptoms after 4 months of age.

    • Failure to thrive.

    • Developmental delays.

    • Maternal drug use.

    • Fever or illness.

    • Parental anxiety or maternal depression.

    • Abnormal physical examination.

    • Bloody stools.

    • Vomiting.

    When to Use
    Why Use

    Infants presenting with recurrent and prolonged crying, fussing or irritability in the absence of any alarm signs. The diagnosis of infant colic should be made by clinical history, positive symptom criteria and a thorough physical examination. Laboratory or imaging studies are not needed to make the diagnosis in the absence of any alarm features.

    • Infant colic is a behavioral syndrome in 1- to 4-month-old infants involving long periods of crying with difficulties to soothe.  

    • Crying bouts occur without obvious cause. 

    • Parents typically assume that crying is related to gastrointestinal pain. There is no evidence that crying results from gastrointestinal dysfunction or pain in other parts of the body. It is very important to explain this to the caregivers. 

    • Prolonged crying tends to occur in the afternoon or evening and peaks at about 4-6 weeks of age, then declines and resolves by 3-4 months of age in full term infants (3-4 months after term). 

    • The “Rule of Threes” as proposed by Wessel et al was historically used to define infant colic (crying 3 or more hours per day for at least 3 days per week) but these criteria appear to be too strict.

    • Even though infant colic is a benign behavioral syndrome, the symptoms can be extremely distressing to the family. 

    • Helplessness experienced by the caregivers as a result of their inability to soothe the crying baby can even trigger shaken baby syndrome or other forms of abuse. Parental support, reassurance and assistance are therefore very important. 

    • Cow’s milk intolerance can cause crying in infants but care should be taken not to overdiagnose cow milk protein allergy to avoid unnecessary dietary restrictions.

    • In the presence of alarm symptoms, further diagnostic evaluation in the form of screening laboratory tests to exclude a urinary tract infection or metabolic abnormalities may be needed. In case of abnormal neurologic evaluation, brain imaging may be needed. 

    • Drug withdrawal needs to be considered with maternal history of or active drug use, though typically presents earlier in the neonatal period.

    • Used to establish the diagnosis of infant colic in babies who present with excessive crying or fussing.

    • Making a diagnosis will allow the physician to provide reassurance to parents, help avoid doctor visits and unnecessary testing and treatments.

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    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