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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neonatal Abstinence Syndrome
• Intervention / Treatment: Dietary supplement: High-calorie formula

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Palmieri, BA; Phone Number: 203-785-4651; Email: lisa.palmieri@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06512
      • Recruiting
      • Yale New Haven Hospital
      • Contact: Matthew Grossman, MD
      • Contact: Francis Cheng, MD; Email: frances.cheng@yale.edu
      • Principal Investigator: Matthew Grossman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-calorie formula; Infant randomly assigned to high-calorie formula for 14 days	Dietary supplement: High-calorie formula; Infant randomly assigned to high-calorie formula for 14 days
No Intervention: Standard calorie formula; Infant randomly assigned to standard-calorie formula for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Length of hospital stay	Measured by comparing admission time to discharge time, assessed at hospital discharge	up to 6.5 days

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2020
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): May 1, 2026

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: high-caloric diet regimens
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Infant, Newborn, Diseases; Body Weight; Body Weight Changes; Weight Gain; Neonatal Abstinence Syndrome
• Other Study ID Numbers: 2000028252; 2T35DK104689-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No