Gastric Emptying in Neonates and Infants After Formula Feeding
Part of paid clinical trials in New York, New York.
- Sponsor
- Columbia University
- Study ID
- NCT02665923
- Status
- Recruiting
Conditions
- Gastric Emptying
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - 12 Months
- Healthy Volunteers
- Accepted
Interventions
- Gastric ultrasound — OTHERUltrasound of abdomen to assess antral volume
Study Details
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).
Key Dates
- Start date
- Mar 31, 2016
- Status verified
- Apr 2026
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 210 participants (estimated)
Arms
- Arm: 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).
- Arm: 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.
- Arm: 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.
Primary Outcome Measure
Gastric Antral Volumes in Newborns [ Time Frame: Up to 6 hours ]
Central Contacts
- Lena S. Sun, MD
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Columbia University Irving Medical Center / NewYork-Presbyterian Hospital | New York | New York | 10032 | Lena S. Sun, MD (PRINCIPAL_INVESTIGATOR) |
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