Gastric Emptying in Neonates and Infants After Formula Feeding

Gastric Emptying Clinical Trial

Official title:

Gastric Emptying in Pediatric Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02665923
• Other study ID #: AAAP6304
• Status: Recruiting
• Start date: March 2016
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• Source: Columbia University
• Contact: Lena S. Sun, MD
• Email: lss4[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Observational

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Emptying

Intervention

Other:
• Gastric ultrasound
Ultrasound of abdomen to assess antral volume

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center / NewYork-Presbyterian Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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