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NCT Number: NCT02665923

Gastric Emptying in Neonates and Infants After Formula Feeding

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).

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Key information

Conditions

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

New York, 10032, United States

Location status: Recruiting

Location contact

Lena S Sun, MD

CONTACT

[email protected]

(212) 305-2413

Lena S. Sun, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • healthy full-term (postmenstrual age ≥ 36 weeks) newborns aged 0-5 days or
  • healthy infants (4-6 months old and 9-12 months old)

Exclusion criteria

are individuals who have

  • newborn history of requirement resuscitation at delivery
  • newborn history of admission to the Neonatal Intensive Care Unit
  • any history of hospital admission
  • history of gastroesophageal reflux or other feeding difficulty
  • receiving any medication known to accelerate or delay gastric emptying, including but not limited to opioid-containing medications and antacids.

Treatment and study plan

Gastric ultrasound

Other

Ultrasound of abdomen to assess antral volume

Primary outcomes

  1. Gastric Antral Volumes in Newborns

    Time frame: Up to 6 hours

    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.

Secondary outcomes

  1. Gastric Antral Volumes in Infants

    Time frame: Up to 6 hours

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lena S. Sun, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Gastric Emptying in Pediatric Patients

Important dates

Study start
2016
Primary completion
2027
Study completion
2027
First posted
Jan 28, 2016
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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