Actively Recruiting
Gastric Emptying in Newborns and Infants Evaluated by Ultrasound Imaging
Led by Columbia University · Updated on 2026-04-23
210
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how quickly the stomach empties in healthy newborns and infants after feeding with formula or clear liquids, including breast milk or formula. This observational study aims to understand age-related changes in gastric emptying by comparing newborns and infants at different ages. The study originally planned to follow newborns over time but was revised to recruit infants at specific age groups due to interruptions caused by the pandemic. The study involves giving formula feeding of a known volume to healthy newborns and infants aged 4-6 months and 9-12 months. Ultrasound imaging of the stomach's antral volume will be done repeatedly after feeding until the stomach empties. The study includes three groups: newborns, infants aged 4-6 months, and infants aged 9-12 months. Participants will undergo serial ultrasound scans to measure gastric antral volumes for up to six hours after feeding. The researchers will track how the stomach empties over time during these visits. This process helps evaluate differences in gastric emptying related to age. The total participation involves multiple visits for ultrasound imaging to monitor stomach emptying in healthy infants.
CONDITIONS
Brief Title
Gastric Emptying in Neonates and Infants After Formula Feeding
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric patients receiving feeding by formula
- Healthy full-term newborns with postmenstrual age of at least 36 weeks, aged 0 to 5 days
- Healthy infants aged 4 to 6 months
- Healthy infants aged 9 to 12 months
You will not qualify if you...
- History of needing resuscitation at delivery
- History of admission to the Neonatal Intensive Care Unit
- Any history of hospital admission
- History of gastroesophageal reflux or other feeding difficulties
- Receiving any medication known to affect gastric emptying, such as opioid-containing medications or antacids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 hours
Participants undergo formula feeding followed by serial ultrasound imaging to assess gastric antral volume until gastric emptying.
1 visit with multiple ultrasound assessments
Duration - Follow-up visits occur at 4-6 months and 9-12 months of age
Participants are followed up at later ages (4-6 months and 9-12 months) with repeat formula feeding and serial ultrasound imaging to evaluate age-related changes in gastric emptying.
1 to 2 follow-up visits depending on age group
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
Research Team
L
Lena S. Sun, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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