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Gastric Emptying in Neonates and Infants After Formula Feeding

Gastric Emptying in Neonates and Infants After Formula Feeding

Recruiting
12 years and younger
All
Phase N/A

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Overview

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.

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.

Study details
    Gastric Emptying

NCT02665923

Columbia University

27 January 2024

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