Gastric Emptying in Neonates and Infants After Formula Feeding
ConditionGastric Emptying
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 12
SponsorColumbia University
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
healthy full-term (postmenstrual age ≥ 36 weeks) newborns aged 0-5 days or
healthy infants (4-6 months old and 9-12 months old)
Disqualifiers
newborn history of requirement resuscitation at delivery
newborn history of admission to the Neonatal Intensive Care Unit
any history of hospital admission
history of gastroesophageal reflux or other feeding difficulty
Trial population
The study will be performing serial ultrasounds in total of 100 healthy newborns, and 50 4-6 months old and 50 9-12 months old infants.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Gastric ultrasound
Other interventionUltrasound of abdomen to assess antral volume
Treatment groups
210 Participants
are divided into 3 treatment groupsGroup A: Newborn (gastric emptying)1 intervention
Group B: Infants (4-6mons)0 interventions
Group C: Infants (9-12 months)0 interventions
Trial outcomes
Primary outcomes
1
Gastric Antral Volumes in Newborns
To determine gastric emptying time in newborns, serial gastric antral volumes will be measured before and after formula feeding until return to baseline measurements at 10-15 minute intervals.
Time frame
Up to 6 hoursSecondary outcomes
1
Gastric Antral Volumes in Infants
To determine gastric emptying time in 4-6 months old and 9-12 months old infants. serial gastric antral volumes will be measured before and after formula feeding until return to baseline measurements at 10-15 minute intervals.
Time frame
Up to 6 hoursSponsors and contacts
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Source ClinicalTrials.gov