NCT02665923

Gastric Emptying in Neonates and Infants After Formula Feeding

Gastric Emptying in Pediatric Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 210 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 12 Months
• Healthy volunteers: Accepted

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).

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.

Conditions

• Gastric Emptying

Interventions

Type	Name	Description
OTHER	Gastric ultrasound	Ultrasound of abdomen to assess antral volume

Timeline

• Start date: 2016-03-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2016-01-28
• Last updated: 2025-03-27

Locations

1 site across 1 country: United States