Clinical Trial to Decrease Length of Stay in Infants With Neonatal Abstinence Syndrome With an Exclusive Human Milk Diet

A Single Center Randomized Controlled Trial to Decrease Length of Stay in Infants With Neonatal Abstinence Syndrome (NAS) With an Exclusive Human Milk Diet

A clinical trial to evaluate length of stay, growth velocity and clinical outcomes in infants with neonatal abstinence syndrome receiving an exclusive human milk diet. Human milk is defined as expressed human milk or donor milk and its derivatives, human milk-based fortifier and human milk caloric fortifier.

Study Overview

• Status: Completed
• Conditions: Neonatal Abstinence Syndrome
• Intervention / Treatment: Other: Human Milk; Other: Standard of Care

Detailed Description

This is a single blinded (physician investigator), randomized, controlled trial to evaluate length of stay in infants with NAS and an exclusive human milk diet during their initial hospitalization after birth and through the 28 days of life or hospital discharge, whichever comes first.

Subjects will be randomized to one of two groups after at birth. Parents who decline participation for their infants in the study will be asked to consent to data gathering on their infants who will be treated and fed per institutional practice. The data on these individuals will be summarized and evaluated descriptively in comparison with the actual trial results.

All experimental group participants will receive exclusive maternal human milk or donor human milk prior to randomization. Once randomized, patients in Group One will receive an exclusive human milk diet throughout the 28-day feeding period or until hospital discharge, whichever comes first. Patients in Group Two (Control Group) will receive maternal human milk or formula (per standard of care). Fortification will be implemented with a standard protocol.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • MARC - The University of Texas Health Science Center
    • San Antonio, Texas, United States, 78207
      • University Health System, Robert B Green

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 days (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Term infants (≥37 and 0/7 weeks gestational age) ≤ 2 days old with a diagnosis or at risk for neonatal abstinence syndrome. Can be enrolled ante-natally.
2. Infant feeding was NPO (nil per os) or consisted of 100% human milk diet prior to randomization.
3. Parent(s) willing to sign informed consent.
4. Parent(s) willing to comply with study follow-up procedures.

Exclusion Criteria:

1. Term infants >2 days old at the time of evaluation for NAS.
2. <37 weeks gestation.
3. Outborn infants who received enteral nutrition at the other institution prior to transfer. If it is uncertain if infant received even 1 bottle or a small amount of formula, infants will be excluded.

4. Major congenital abnormalities:

   1. Confirmed or suspected major genetic abnormalities (lethal or with extremely low probability for survival).
   2. Chromosomal abnormalities: Trisomies (13, 18, 21 etc.) deletions or translocations (Turner/Williams Syndrome, DiGeorge, to name a few).
   3. Major organ system abnormalities not related to a genetic syndrome that are lethal or have extremely low probability for survival (i.e, bilateral kidney intrinsic disease, pulmonary hypoplasia, CNS (central nervous system) malformations: Arnold Chiari, myelomengoceles, hydranencephaly, squizencephaly, holoprocencephaly).
5. Any comorbidity or significant clinical event prior to enrollment, deemed by the Investigator as likely to affect survival or intestinal health.
6. Legally Authorized Representative(s) unwilling to comply with an exclusive human milk diet either in the form of mother's milk, human milk-based human milk fortifier, human milk based caloric fortifier or donor human milk during the initial hospitalization period and through the 28 day feeding period or hospital discharge, whichever comes first.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Exclusive Human Milk; Group One will receive an exclusive human milk diet throughout the 28-day feeding period or until hospital discharge	Other: Human Milk; Exclusive Human Milk diet; Other Names: 100% Human Milk
Other: Maternal human milk or Formula; Group Two (Control Group) will receive maternal human milk or formula (per standard of care).	Other: Standard of Care; This diet will include mother's milk and/or formula; Other Names: Mother's milk and/or formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Hospital Stay	Length of stay in infants at risk for neonatal abstinence syndrome who are fed an exclusive human milk diet from birth through the 28-day feeding period or until hospital discharge, whichever comes first	Baseline to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth Velocity Rate	rate of linear growth and incremental rate of head circumference growth; gm/week, cm/week and z-score from World Health Organization (WHO) growth charts	Baseline to 28 days
Body Composition Percentage Fat	Body composition using Peapod at 28 days or discharge. The PEA POD uses the principles of wholebody densitometry to determine body composition. In this technique, body mass and body volume are measured (both performed within the unit). Once body density (Density = Mass/Volume) is determined, the PEA POD uses known (or user customized) densitometric equations to calculate percent Fat.	28 days
Body Composition Percentage Fat Free Mass	Body composition using Peapod. The PEA POD uses the principles of wholebody densitometry to determine body composition. In this technique, body mass and body volume are measured (both performed within the unit). Once body density (Density = Mass/Volume) is determined, the PEA POD uses known (or user customized) densitometric equations to calculate percent Fat-Free Mass.	28 Days

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Investigators: Principal Investigator: Cynthia Blanco, MD, MSCI-TS, University of Texas Health at San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2020
• Primary Completion (Actual): May 29, 2025
• Study Completion (Actual): May 29, 2025

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 7, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: human milk
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Infant, Newborn, Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Syndrome; Neonatal Abstinence Syndrome
• Other Study ID Numbers: HSC20200179H

Drug and device information, study documents

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