Gastric Emptying in Neonates and Infants After Formula Feeding

Columbia University

Status: Enrolling

Conditions: Gastric Emptying

Treatments: Other: Gastric ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT02665923

AAAP6304

Details and patient eligibility

About

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).

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: Under 12 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

210 participants in 3 patient groups

Newborn (gastric emptying)

Description:

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).

Treatment:

Other: Gastric ultrasound

Infants (4-6mons)

Description:

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)

Description:

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.