Status:
COMPLETED
Clinical Trial to Decrease Length of Stay in Infants With Neonatal Abstinence Syndrome With an Exclusive Human Milk Diet
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Conditions:
Neonatal Abstinence Syndrome
Eligibility:
All Genders
Up to 48 years
Phase:
NA
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 express...
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 aft...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2025
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04508348
Start Date
August 31 2020
End Date
May 29 2025
Last Update
July 8 2025
Active Locations (2)
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1
University Health System, Robert B Green
San Antonio, Texas, United States, 78207
2
MARC - The University of Texas Health Science Center
San Antonio, Texas, United States, 78229