Gastric Emptying in Neonates and Infants After Formula Feeding
NCT ID: NCT02665923
Last Updated: 2025-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
210 participants
OBSERVATIONAL
2016-03-31
2026-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Newborn (gastric emptying)
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).
Gastric ultrasound
Ultrasound of abdomen to assess antral volume
Infants (4-6mons)
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.
No interventions assigned to this group
Infants (9-12 months)
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.
No interventions assigned to this group
Interventions
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Gastric ultrasound
Ultrasound of abdomen to assess antral volume
Eligibility Criteria
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Inclusion Criteria
2. healthy infants (4-6 months old and 9-12 months old)
Exclusion Criteria
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.
12 Months
ALL
Yes
Sponsors
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Columbia University
OTHER
Responsible Party
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Lena S. Sun
Emanuel M. Papper Professor of Anesthesiology and Professor of Pediatrics
Principal Investigators
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Lena S. Sun, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AAAP6304
Identifier Type: -
Identifier Source: org_study_id
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