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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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. | ||
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastric ultrasound | Other | Ultrasound of abdomen to assess antral volume |
|
| 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 |
| 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 |
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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
Exclusion criteria are individuals who have
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lena S. Sun, MD | Contact | lss4@cumc.columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lena S. Sun, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center / NewYork-Presbyterian Hospital | Recruiting | New York | New York | 10032 | United States |
Sharing through written communication and request to PI
Available within 12 months after analysis of results is completed and published.
Upon review and request.
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