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

NCT04508348 | Completed

• 1 other identifier: HSC20200179H
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Neonatal Abstinence Syndrome

Keywords

human milk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Growth Velocity Rate

  Baseline to 28 days

• Body Composition Percentage Fat

  28 days

• Body Composition Percentage Fat Free Mass

  28 Days

Study Arms (2)

Exclusive Human Milk

ACTIVE COMPARATOR

Group One will receive an exclusive human milk diet throughout the 28-day feeding period or until hospital discharge

Other: Human Milk

Maternal human milk or Formula

OTHER

Group Two (Control Group) will receive maternal human milk or formula (per standard of care).

Other: Standard of Care

Interventions

Human Milk OTHER

Exclusive Human Milk diet

Also known as: 100% Human Milk

Exclusive Human Milk

Standard of Care OTHER

This diet will include mother's milk and/or formula

Also known as: Mother's milk and/or formula

Maternal human milk or Formula

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Infant feeding was NPO (nil per os) or consisted of 100% human milk diet prior to randomization.
• Parent(s) willing to sign informed consent.
• Parent(s) willing to comply with study follow-up procedures.

You may not qualify if:

• Term infants \>2 days old at the time of evaluation for NAS.
• \<37 weeks gestation.
• 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.
• Major congenital abnormalities:
• Confirmed or suspected major genetic abnormalities (lethal or with extremely low probability for survival).
• Chromosomal abnormalities: Trisomies (13, 18, 21 etc.) deletions or translocations (Turner/Williams Syndrome, DiGeorge, to name a few).
• 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).
• Any comorbidity or significant clinical event prior to enrollment, deemed by the Investigator as likely to affect survival or intestinal health.
• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (2)

University Health System, Robert B Green

San Antonio, Texas, 78207, United States

Location

MARC - The University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Interventions

Milk, Human; Standard of Care

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Cynthia Blanco, MD, MSCI-TS

  University of Texas Health at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Physician Investigator will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, blinded, controlled trial

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 11, 2020
• Study Start: August 31, 2020
• Primary Completion: May 29, 2025
• Study Completion: May 29, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

US (2)