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 — OTHER
    Ultrasound 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

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical Center / NewYork-Presbyterian HospitalNew YorkNew York10032
Lena S Sun, MD
(212) 305-2413
Lena S. Sun, MD (PRINCIPAL_INVESTIGATOR)

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