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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
19
Exclusive Human Milk diet
This diet will include mother's milk and/or formula
University Health System, Robert B Green
San Antonio, Texas, United States
MARC - The University of Texas Health Science Center
San Antonio, Texas, United States
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
Time frame: Baseline to 28 days
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
Time frame: 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.
Time frame: 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.
Time frame: 28 Days
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