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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
486
maternal breastmilk or donor breastmilk
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGUniversity of Mississippi Medical Center
Jackson, Mississippi, United States
NOT_YET_RECRUITINGUniversity of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Fat-free Mass (FFM)-For-age-Z-score
Estimated by bioelectric impedance analysis. FFM measurements will be converted into Z-scores using updated, sex specific reference curves of body composition in preterm infants
Time frame: 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer
Body fat percentage
Estimated by bioelectric impedance analysis. Body fat measurements will be converted into Z-scores using updated sex-specific reference curves of body composition in preterm infants.
Time frame: Birth to 36 weeks postmenstrual age
Anthropometric Measurements
Weight, length, head circumference, and mid-upper arm circumference measurements. Measurements will be converted into Z-scores based on Fenton growth curves (2013).
Time frame: Birth to 36 weeks postmenstrual age
Bronchopulmonary Dysplasia
Number of participants receiving supplemental oxygen at 36 weeks (PMA)
Time frame: 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer
Number of Days Alive and Receiving Full Enteral Feeding
Time to full enteral feeding days
Time frame: Birth to 28 days
Duration of Hospital Stay in Days
From day of admission to day of hospital discharge to home
Time frame: Birth to 120 days or discharge, whichever occurs first
Growth Rate
Weight gain in g/kg/day
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University of Texas Health Science Center at Houston
Houston, Texas, United States
NOT_YET_RECRUITINGTime frame: Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurs first).
Number of Participants with Postnatal Faltering Growth
Diagnosis of faltering growth (weight z score decline from birth to 36 weeks \> 1) using the 2013 Fenton growth curve.
Time frame: 36 weeks or hospital discharge (whichever occurs first)
Number of Participants diagnosed with Necrotizing Enterocolitis
Diagnosis of necrotizing enterocolitis stage 2 or 3
Time frame: From birth up to 120 days following birth
Number of Participants with Diagnosis of Intestinal Perforation
Diagnosis of intestinal perforation
Time frame: From birth up to 120 days following birth
Death
Death prior to 121 days of life
Time frame: Birth to 120 days
Culture-proven Sepsis
Diagnosis of sepsis with positive blood cultures
Time frame: Birth to 120 days
Fat Mass (FM)- For age Z-score
Estimated by bioelectric impedance analysis. FM measurements will be converted into Z-scores using updated sex-specific reference curves of body composition in preterm infants.
Time frame: 36 weeks or hospital discharge, up to 120 days following birth, whichever is longer
Body Fat (BF)-For age Z-score
Estimated by bioelectric impedance analysis. BF measurements will be converted into Z-scores using updated sex-specific reference curves of body composition in preterm infants.
Time frame: 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer
Duration of parenteral nutrition
Number of days receiving parenteral nutrition
Time frame: Birth to 28 days of life
Post discharge growth outcomes
Weight, length, and head circumference measurements. Measurements will be converted into Z-scores.
Time frame: 22-26 months corrected age