Clinical Trial to Decrease Length of Stay in Infants With Neonatal Abstinence Syndrome With an Ex… (NCT04508348) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial to Decrease Length of Stay in Infants With Neonatal Abstinence Syndrome With an Exclusive Human Milk Diet
United States19 participantsStarted 2020-08-31
Plain-language 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.
Who can participate
Age range48 Hours
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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).
What they're measuring
1
Length of Hospital Stay
Timeframe: Baseline to 28 days
Trial details
NCT IDNCT04508348
SponsorThe University of Texas Health Science Center at San Antonio