Gastric Emptying in Neonates and Infants After Formula Feeding

Gastric Emptying in Pediatric Patients

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).

Study Overview

• Status: Recruiting
• Conditions: Gastric Emptying
• Intervention / Treatment: Other: Gastric ultrasound

Detailed Description

The study involves serial ultrasounds over several visits. Healthy newborns in the Newborn Nursery will be recruited to conduct this study. The study will include a total of 50 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.

The study originally was designed to perform follow up of these newborns at two later time intervals (between ages 4-6 months, and 9-12 months). The purpose of follow-up is to evaluate whether there are age-related changes in gastric emptying. Due to the pause/suspension of research activity during the pandemic, these follow up studies of the original newborn cohort could not be completed. The protocol is thus revised as follows:

The study will recruit 50 4-6 months old and 50 9-12months old infants and perform gastric emptying serial ultrasound to evaluate if there are age-related changes in gastric emptying.

• Study Type: Observational
• Enrollment (Estimated): 210

Contacts and Locations

• Study Contact: Name: Lena S. Sun, MD; Email: lss4@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
      • Principal Investigator: Lena S. Sun, MD
      • Contact: Lena S Sun, MD; Phone Number: (212) 305-2413; Email: lss4@cumc.columbia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study will be performing serial ultrasounds in total of 100 healthy newborns, and 50 4-6 months old and 50 9-12 months old infants.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Other: Gastric ultrasound; Ultrasound of abdomen to assess antral volume
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric Antral Volumes in Newborns	To determine gastric emptying time in newborns, serial gastric antral volumes will be measured before and after formula feeding until return to baseline measurements at 10-15 minute intervals.	Up to 6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric Antral Volumes in Infants	To determine gastric emptying time in 4-6 months old and 9-12 months old infants. serial gastric antral volumes will be measured before and after formula feeding until return to baseline measurements at 10-15 minute intervals.	Up to 6 hours

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Lena S. Sun, MD, Columbia University

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: January 25, 2016
• First Submitted That Met QC Criteria: January 25, 2016
• First Posted (Estimated): January 28, 2016

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: AAAP6304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sharing through written communication and request to PI
• IPD Sharing Time Frame: Available within 12 months after analysis of results is completed and published.
• IPD Sharing Access Criteria: Upon review and request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No