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Purpose

The goal of this multi-center randomized, parallel group trial is to determine the effect of human milk diets ranging between 180 and 200 mL/kg/day on the body composition outcomes of moderately preterm infants born between 27 and 31 weeks of gestation.

Condition

Eligibility

Eligible Ages
Between 6 Hours and 4 Days
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Gestational age between 27 0/7 and 31 6/7 weeks - Birthweight of 1500 grams or less - Human milk feeding during the first 14 days after birth - Full enteral feeding (120mL/kg/day or more) within the first 14 days after birth

Exclusion Criteria

  • Necrotizing enterocolitis stage 2 or greater - Spontaneous intestinal perforation - Major congenital/chromosomal anomalies - Terminal illness requiring limited or withheld support - Intention to restrict fluid intake after the first 14 postnatal days due to the presence of a symptomatic patent ductus arteriosus (PDA) - Any formula feeding within the first 14 days after birth

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Intervention: 180-200 mL/kg/day of human milk 		Study participants randomized to the intervention group will receive 180-200 mL/kg/day of human milk for 34 weeks corrected age.
  • Dietary Supplement: Human milk
    maternal breastmilk or donor breastmilk
Placebo Comparator
Control:140-160 mL/kg/day of human milk 		Study participants randomized to the control group will receive 140-160 mL/kg/day of human milk for 34 weeks corrected age.
  • Dietary Supplement: Human milk
    maternal breastmilk or donor breastmilk

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Ariel A. Salas, MD, MSPH
205-934-4680
asalas@uab.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Ariel A. Salas, MD, MSPH
205-934-4680
asalas@uab.edu

Detailed Description

Participants will be randomized once they reach 120 mL/kg/day. Clinicians will be able to increase feeds each day as they see fit, until the patient reaches the target goal of 140-160 mL/kg/day or 180-200 mL/kg/day. They will then maintain this volume until 34 weeks postmenstrual age. Researchers will compare these two targets to see if higher feeding volumes prevent faltering growth without causing adverse metabolic outcomes. Participants will: - Have a feeding volume of 180-200 mL/kg/day or a volume of 140-160 mL/kg/day until 34 weeks corrected age - Have four body composition assessments with a bioelectrical impedance analyzer throughout study period - Have four stool samples collected throughout study period - Have four maternal breastmilk samples collected and analyzed throughout the study period - Have one blood sample collected at 36 weeks corrected age - Have the option to participate in a follow-up survey completed by parents at 2-3 years of age

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.