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 type | Observational |
|---|---|
| Ages | Any age to 12 Months |
| Sex | All |
| Enrollment | 210 (estimated) |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | March 2016 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT02665923 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
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Gastric emptying and feeding tolerance in ICU patients by vasopressor dose
This study tests whether vasopressor dose affects how well stomach contents empty during tube feeding in critically ill patients.
-
Sipping water versus carbohydrate drinks while waiting for an elective caesarean
This will test whether sipping a carbohydrate drink instead of water while waiting for an elective caesarean changes stomach contents and improves recovery for pregnant women having caesarean delivery under regional anesthesia.
-
Does adding protein to a carbohydrate drink change stomach emptying in older adults?
This test will see if a drink with both protein and carbohydrates slows stomach emptying or causes stomach symptoms in people aged 60–90.
-
Gastric emptying in women in early labor with different drinks
This study tests how quickly the stomach empties in women in early labor after drinking water or a sports drink, while also looking at their hunger levels and whether they received epidural pain relief.
-
Comparing how different amounts of clear fluids affect stomach contents in children before surgery
This study is testing how different amounts of clear fluids before surgery can affect the stomach contents of children aged 13 to 17 to find the best way to keep them hydrated and safe.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.