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Clinical Trial 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).


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT02665923
Study type Observational
Source Columbia University
Contact Lena S. Sun, MD
Email lss4@cumc.columbia.edu
Status Recruiting
Phase
Start date March 2016
Completion date April 2025

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