RecruitingNot Applicable

Gastric Emptying in Neonates and Infants After Formula Feeding

United States210 participantsStarted 2016-03

Plain-language summary

Ultrasound imaging will be used to evaluate time for gastric emptying in healthy, fasting newborns, and infants following feeding of clear liquids and/or milk (including breast or formula).

Who can participate

Age range

12 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Gastric Antral Volumes in Newborns

Timeframe: Up to 6 hours

Trial details

NCT IDNCT02665923

SponsorColumbia University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-06

Contact for this trial

Lena S. Sun, MD

lss4@cumc.columbia.edu

View on ClinicalTrials.gov More Gastric Emptying trials