Clinical trial Recruiting at 1 site Observational Ages Any age to 12 Months

Evaluating how quickly newborns and infants empty their stomachs after feeding

Official title: Gastric Emptying in Pediatric Patients

Run by Columbia University · NCT02665923 · Data updated 2026-11-12

This study is testing how quickly healthy newborns and infants empty their stomachs after drinking clear liquids or formula to learn more about their digestion.

Quick facts

Study typeObservational
AgesAny age to 12 Months
SexAll
Enrollment210 (estimated)
SponsorColumbia University
Academic / other
Locations1 site (New York, New York)
StatusRecruiting
StartedMarch 2016
Main results expectedJune 2027
Study endsJune 2027
Registry record updatedApril 23, 2026
Trial IDNCT02665923 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include healthy full-term newborns aged 0-5 days and healthy infants aged 4-12 months who are being fed formula.

Probably not a fit

Patients with a history of resuscitation at delivery, NICU admission, feeding difficulties, or those on medications affecting gastric emptying may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study uses ultrasound imaging to assess gastric emptying times in healthy newborns and infants after they are fed clear liquids or formula. A total of 100 participants will be recruited, including 50 healthy newborns and 50 infants aged 4-12 months. Serial ultrasounds will be conducted to measure gastric antral volume until gastric emptying occurs, allowing researchers to evaluate potential age-related changes in gastric emptying. The study aims to provide insights into normal gastric function in early life.

Why it matters

Potential benefit: If successful, this study could enhance understanding of gastric emptying in infants, potentially leading to improved feeding practices and management of feeding-related issues.

How similar studies have gone: While studies on gastric emptying exist, this specific approach using ultrasound in this age group is relatively novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion criteria for study cohort are pediatric patients from Allen Hospital and Morgan Stanley Children's Hospital of New York Presbyterian Hospital who are receiving feeding by formula

1. healthy full-term (postmenstrual age ≥ 36 weeks) newborns aged 0-5 days or
2. healthy infants (4-6 months old and 9-12 months old)

Exclusion criteria are individuals who have

1. newborn history of requirement resuscitation at delivery
2. newborn history of admission to the Neonatal Intensive Care Unit
3. any history of hospital admission
4. history of gastroesophageal reflux or other feeding difficulty
5. receiving any medication known to accelerate or delay gastric emptying, including but not limited to opioid-containing medications and antacids.

Where it's running

  • Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
    New York, New York, United States
    Recruiting

Study contacts

  • Principal investigator: Lena S. Sun, MD — Columbia University
  • Study coordinator: Lena S. Sun, MD
  • Email: lss4@cumc.columbia.edu

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.