Gastric Emptying in Neonates and Infants After Formula Feeding

Study Overview
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Brief Summary
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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).

Detailed Description
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The study involves serial ultrasounds over several visits. Healthy newborns in the Newborn Nursery will be recruited to conduct this study. The study will include a total of 50 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. The study originally was designed to perform follow up of these newborns at two later time intervals (between ages 4-6 months, and 9-12 months). The purpose of follow-up is to evaluate whether there are age-related changes in gastric emptying. Due to the pause/suspension of research activity during the pandemic, these follow up studies of the original newborn cohort could not be completed. The protocol is thus revised as follows: The study will recruit 50 4-6 months old and 50 9-12months old infants and perform gastric emptying serial ultrasound to evaluate if there are age-related changes in gastric emptying.

Official Title
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Gastric Emptying in Pediatric Patients

Conditions
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Gastric Emptying

Intervention / Treatment
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* Other: Gastric ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for study cohort are pediatric patients from Allen Hospital and Morgan Stanley Children's Hospital of New York Presbyterian Hospital who are receiving feeding by formula healthy full-term (postmenstrual age ≥ 36 weeks) newborns aged 0-5 days or healthy infants (4-6 months old and 9-12 months old) Exclusion criteria are individuals who have 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 receiving any medication known to accelerate or delay gastric emptying, including but not limited to opioid-containing medications and antacids.

Ages Eligible for Study
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Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newborn (gastric emptying)<br>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). | Other: Gastric ultrasound<br>* Ultrasound of abdomen to assess antral volume<br>|
| Infants (4-6mons)<br>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. | |
| Infants (9-12 months)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 6 hours |