Recruiting

Observational Study

Sponsor:

Columbia University

Code:

NCT02665923

Conditions

Gastric Emptying

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Accepted

Interventions

Gastric ultrasound

Study Details

Brief 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).

Conditions

Gastric Emptying

Study ID

NCT02665923

Start date

Mar, 2016

Status verified date

Apr, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

210 participants

Anticipated

Interventions and Outcome Measures

Arms

Newborn (gastric emptying)

A total of 100 healthy newborns who will be given formula feeding of known volume, and then serial ultrasound imaging of gastric antral volume will be performed until gastric emptying. Follow up of these newborns at two later time intervals will be performed (between ages 4-6 months, and 9-12 months).

Infants (4-6mons)

50 Patients will undergowill be given formula feeding of known volume, and then serial ultrasound imaging of gastric antral volume will be performed until gastric emptying.

Infants (9-12 months)

50 Patients will undergowill be given formula feeding of known volume, and then serial ultrasound imaging of gastric antral volume will be performed until gastric emptying.

Interventions

Gastric ultrasound

Ultrasound of abdomen to assess antral volume

Primary outcome measure

  • Gastric Antral Volumes in Newborns [ Time Frame: Up to 6 hours ]

Central Contacts and Locations

Central contacts

Lena S. Sun, MD

lss4@cumc.columbia.edu

Locations

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

Recruiting

New York, New York, United States, 10032

Contacts

Lena S Sun, MD

(212) 305-2413lss4@cumc.columbia.edu

Principal Investigator:

Lena S. Sun, MD

More Information

Sponsor

Columbia University

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-04-23.