A Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants

Neonatal Abstinence Syndrome Clinical Trial

Official title:

A Randomized Control Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04419857
• Other study ID #: 2000028252
• Secondary ID: 2T35DK104689-06
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2020
• Est. completion date: May 2026

Study information

• Verified date: April 2023
• Source: Yale University
• Contact: Lisa Palmieri, BA
• Phone: 203-785-4651
• Email: lisa.palmieri[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized clinical study in NAS infants managed via the Eat, Sleep, Console (ESC) approach comparing early weight loss on a standard-caloric density versus high-caloric density feeding regimen.

Description:

The aims of the study is to systematically evaluate the benefit of high-caloric diet regimens given to NAS infants in the first three weeks of life. Breastfeeding is the preferred feeding method for NAS infants as it has shown to reduce NAS severity and infant weight loss, though women who are not adherent to drug treatment programs or have the potential to use illicit drugs are not able to breastfeed due to the risks posed to the infant. Several studies have demonstrated the potential for caloric enhancement of formula and breast milk to support weight gain in NAS infants. Through a randomized control trial analyzing infant weight gain on standard-calorie vs. high-calorie diet regimens, we aim to quantify weight patterns in NAS infants and show that increasing caloric intake can improve weight gain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Infant Inclusion Criteria:

• Infants with NAS born to mothers age 18-45 with methadone exposure before or during pregnancy who do not intend to place their infants for adoption
• Infants > 2200 g Infants at least 36 weeks gestational age
• Delivered at: Yale New Haven Hospital
• Mothers/infants able to return to outpatient pediatric provider for 2 month and 4 month weights visits

Infant Exclusion Criteria:

• Infants with major congenital malformations
• Infants enrolled to NICU >24 hours for medical conditions other than NAS treatment before 3 days of life Mother's Inclusion criteria -
• Pregnant women (age 18-45) who have started methadone treatment at obstetrics or other YNHH appointments
• Confirm methadone treatment is received from a licensed treatment program
• Confirm that mothers are planning to deliver their infant(s) at Yale New Haven Hospital
• Confirm that mothers do not intend to place the infant(s) for adoption
• Confirm mother's willingness to participate in the study (including attending the 2-month and 4-month follow up weigh-ins with pediatrician)
• Consent forms will be signed and faxed to study staff

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome
• Weight Gain

Intervention

Dietary Supplement:
• High-calorie formula
Infant randomly assigned to high-calorie formula for 14 days

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal percent weight loss compared to birth weight	this will be measured by twice daily weights while in the hospital and once daily weights at home for two weeks after birth compared with birth weight	2 weeks
Secondary	Hours to weight nadir	Measured by determining the hours of life that the maximal percent weight loss was obtained for each patient, assessed within the first two weeks after birth	2 weeks
Secondary	Days to return to birthweight	Measured by determining the days of life each patient regained birthweight, assessed within the first month after birth	1 month
Secondary	Percent weight change per day	Measured by comparing the weight from the weight obtained the day prior, assessed daily for the first two weeks after birth	2 weeks
Secondary	Length of hospital stay	Measured by comparing admission time to discharge time, assessed at hospital discharge	up to 6.5 days