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NCT06420531 | NOT YET RECRUITING | Prematurity

Optimizing Human Milk Intake for Growth and Gut Health in Very Preterm Infants
Sponsor:

University of Alabama at Birmingham

Information provided by (Responsible Party):

Ariel A. Salas

Brief Summary:

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 or disease

Prematurity

Intervention/treatment

Human milk

Phase

NA

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

Study Type : INTERVENTIONAL
Estimated Enrollment : 486 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Multicenter Randomized Clinical Trial Comparing Two Human Milk Volumes to Optimize Growth and Gut Health in Infants Born Very Preterm
Actual Study Start Date : 2025-04
Estimated Primary Completion Date : 2028-06
Estimated Study Completion Date : 2030-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 6 Hours to 4 Days
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Optimizing Human Milk Intake for Growth and Gut Health in Very Preterm Infants

Location Details

NCT06420531

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Locations

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