Prematurity
Conditions
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.
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
Interventions
DIETARY_SUPPLEMENTHuman milk
maternal breastmilk or donor breastmilk
Sponsors
University of Alabama at Birmingham
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
6 Years to 4 Days
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fat-free Mass (FFM)-For-age-Z-score | 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body fat percentage | Birth to 36 weeks postmenstrual age | 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. |
| Anthropometric Measurements | Birth to 36 weeks postmenstrual age | Weight, length, head circumference, and mid-upper arm circumference measurements. Measurements will be converted into Z-scores based on Fenton growth curves (2013). |
| Bronchopulmonary Dysplasia | 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer | Number of participants receiving supplemental oxygen at 36 weeks (PMA) |
| Number of Days Alive and Receiving Full Enteral Feeding | Birth to 28 days | Time to full enteral feeding days |
| Duration of Hospital Stay in Days | Birth to 120 days or discharge, whichever occurs first | From day of admission to day of hospital discharge to home |
| Growth Rate | Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurs first). | Weight gain in g/kg/day |
| Number of Participants with Postnatal Faltering Growth | 36 weeks or hospital discharge (whichever occurs first) | Diagnosis of faltering growth (weight z score decline from birth to 36 weeks \> 1) using the 2013 Fenton growth curve. |
| Number of Participants diagnosed with Necrotizing Enterocolitis | From birth up to 120 days following birth | Diagnosis of necrotizing enterocolitis stage 2 or 3 |
| Number of Participants with Diagnosis of Intestinal Perforation | From birth up to 120 days following birth | Diagnosis of intestinal perforation |
| Death | Birth to 120 days | Death prior to 121 days of life |
| Culture-proven Sepsis | Birth to 120 days | Diagnosis of sepsis with positive blood cultures |
| Fat Mass (FM)- For age Z-score | 36 weeks or hospital discharge, up to 120 days following birth, whichever is longer | 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. |
| Body Fat (BF)-For age Z-score | 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer | 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. |
| Duration of parenteral nutrition | Birth to 28 days of life | Number of days receiving parenteral nutrition |
| Post discharge growth outcomes | 22-26 months corrected age | Weight, length, and head circumference measurements. Measurements will be converted into Z-scores. |
Countries
United States
Contacts
CONTACTAriel A. Salas, MD, MSPH
PRINCIPAL_INVESTIGATORAriel A. Salas, MD, MSPH
UAB Hospital
Outcome results
None listed