Evaluating how quickly newborns and infants empty their stomachs after feeding
Gastric Emptying in Pediatric Patients
This study is testing how quickly healthy newborns and infants empty their stomachs after drinking clear liquids or formula to learn more about their digestion.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 210 (estimated) |
| Ages | N/A to 12 Months |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT02665923 on ClinicalTrials.gov |
What this trial studies
This observational study uses ultrasound imaging to assess gastric emptying times in healthy newborns and infants after they are fed clear liquids or formula. A total of 100 participants will be recruited, including 50 healthy newborns and 50 infants aged 4-12 months. Serial ultrasounds will be conducted to measure gastric antral volume until gastric emptying occurs, allowing researchers to evaluate potential age-related changes in gastric emptying. The study aims to provide insights into normal gastric function in early life.
Who should consider this trial
Good fit: Ideal candidates include healthy full-term newborns aged 0-5 days and healthy infants aged 4-12 months who are being fed formula.
Not a fit: Patients with a history of resuscitation at delivery, NICU admission, feeding difficulties, or those on medications affecting gastric emptying may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of gastric emptying in infants, potentially leading to improved feeding practices and management of feeding-related issues.
How similar studies have performed: While studies on gastric emptying exist, this specific approach using ultrasound in this age group is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 1. healthy full-term (postmenstrual age ≥ 36 weeks) newborns aged 0-5 days or 2. healthy infants (4-6 months old and 9-12 months old) Exclusion criteria are individuals who have 1. newborn history of requirement resuscitation at delivery 2. newborn history of admission to the Neonatal Intensive Care Unit 3. any history of hospital admission 4. history of gastroesophageal reflux or other feeding difficulty 5. receiving any medication known to accelerate or delay gastric emptying, including but not limited to opioid-containing medications and antacids.
Where this trial is running
New York, New York
- Columbia University Irving Medical Center / NewYork-Presbyterian Hospital — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Lena S. Sun, MD — Columbia University
- Study coordinator: Lena S. Sun, MD
- Email: lss4@cumc.columbia.edu
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.