Gastric Emptying in Neonates and Infants After Formula Feeding
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gastric ultrasound.
- Who it may be relevant to
- Registry conditions: Gastric Emptying. Basic parameters: up to 12 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Gastric Emptying in Pediatric Patients
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).
Detailed 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.
Interventions
- Other Gastric ultrasound
Ultrasound of abdomen to assess antral volume
Primary outcome measures
- Gastric Antral Volumes in Newborns [Time frame: Up to 6 hours]
Secondary outcome measures (1)
- Gastric Antral Volumes in Infants [Time frame: Up to 6 hours]
Eligibility 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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Columbia University Irving Medical Center / NewYork-Presbyterian Hospital — New York
Identifiers
NCT: NCT02665923 · AAAP6304