Gastric Emptying in Neonates and Infants After Formula Feeding

NCT02665923 | Recruiting

• 1 other identifier: AAAP6304
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Gastric Antral Volumes in Infants

  Up to 6 hours

Study Arms (3)

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

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 OTHER

Ultrasound of abdomen to assess antral volume

Newborn (gastric emptying)

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

New York, New York, 10032, United States

RECRUITING

Study Officials

• Lena S. Sun, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lena S. Sun, MD

CONTACT

lss4@cumc.columbia.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emanuel M. Papper Professor of Anesthesiology and Professor of Pediatrics

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: January 28, 2016
• Study Start: March 1, 2016
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Available within 12 months after analysis of results is completed and published.
• Access Criteria: Upon review and request.

Locations

US (1)