High-calorie formula for Neonatal Abstinence Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Neonatal Abstinence SyndromeHigh-calorie formula - DietarySupplement
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

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

1 of 3

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

1 of 3

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: DietarySupplement
Standard 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.