Actively Recruiting

Age: 0 - 12Months
All Genders
Healthy Volunteers
ID02665923

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

Age: 0 - 12Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Long-term Monitoring

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

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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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