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

NCT04508348 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-07-08

No results posted yet for this study

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

Interventions

OTHER

Human Milk

Exclusive Human Milk diet

OTHER

Standard of Care

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

Sponsors & Collaborators

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Cynthia Blanco, MD, MSCI-TS · University of Texas Health at San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-31
Primary Completion
2025-05-29
Completion
2025-05-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04508348 on ClinicalTrials.gov