Study Summary
This trial studied whether a high-calorie diet helps babies with NAS gain weight.
Eligible Conditions
- Neonatal Abstinence Syndrome
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: 1 month
1 month
Days to return to birthweight
2 weeks
Hours to weight nadir
Maximal percent weight loss compared to birth weight
Percent weight change per day
up to 6.5 days
Length of hospital stay
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Standard calorie formula
1 of 2
High-calorie formula
1 of 2
Active Control
Experimental Treatment
100 Total Participants · 2 Treatment Groups
Primary Treatment: High-calorie formula · No Placebo Group · N/A
High-calorie formula
DietarySupplement
Experimental Group · 1 Intervention: High-calorie formula · Intervention Types: DietarySupplementStandard calorie formulaNoIntervention Group · 1 Intervention: Standard calorie formula · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,679 Previous Clinical Trials
21,087,947 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,148 Previous Clinical Trials
4,074,687 Total Patients Enrolled
Matthew Grossman, MDPrincipal InvestigatorYale University
Eligibility Criteria
Age Any Age · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Mothers/infants able to return to outpatient pediatric provider for 2 month and 4 month weights visits.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Conditions
Cancer Related
Treatments