Enteral Feeding Intolerance, Light-For-Dates, Prematurity
Conditions
Brief summary
In this proposed clinical trial, the investigators will randomize 80 very preterm (VPT) infants to receive either early (between day 4 and 7) or delayed (between day 10 and 14) fortification and determine if providing early protein supplementation through early fortification results in higher FFM-for-age z scores and more diversity in the gut microbiome.
Interventions
DIETARY_SUPPLEMENTEarly HMF
Mom's milk or donor milk will be fortified between postnatal day 4 and 7
DIETARY_SUPPLEMENTDelayed HMF
Mom's milk or donor milk will be fortified between postnatal day 10 and 14
Sponsors
University of Alabama at Birmingham
Mead Johnson Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 4 Days
Healthy volunteers
No
Inclusion criteria
* Gestational age 29 to 33 weeks of gestation * Birth weight \< 1800 g * Postnatal age \< 96 hours
Exclusion criteria
* Small for gestational age (\<5th percentile) * Major congenital/chromosomal anomalies * Terminal illness needing withhold or limit support
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fat-free mass(FFM)-for-age Z-score | Postnatal day 14 to 21 | Estimated by air displacement plethysmography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal microbiome composition | Birth to 36 weeks postmenstrual age | Determined by 16S RNA sequencing of bacteria in stool samples |
| Growth - Weight | Birth to 36 weeks postmenstrual age or hospital discharge | Measured weekly in grams and z scores as part of routine care |
| Growth - Length | Birth to 36 weeks postmenstrual age or hospital discharge | Measured weekly in cm and z scores as part of routine care |
| Growth - Head circumference | Birth to 36 weeks postmenstrual age or hospital discharge | Measured weekly in cm and z scores as part of routine care |
| Growth rate | Birth to 36 weeks postmenstrual age or hospital discharge | Weight gain in g/kg/day |
| Number of participants with postnatal growth faltering | Birth to 36 weeks postmenstrual age or hospital discharge | Diagnosis of growth faltering (decline in weight-for-age z score from birth to 36 weeks postmenstrual age greater than 1.2 |
| Number of participants with diagnosis of necrotizing enterocolitis | Birth to 60 days or discharge | Diagnosis of necrotizing enterocolitis stage 2 or 3 |
| Number of participants with diagnosis of intestinal perforation | Birth to 10 days | Diagnosis of intestinal perforation |
| Death | Birth to 60 days | Death prior to postnatal day 60 |
| Duration of hospital stay in days | Birth to 60 days or discharge, whichever occurs first | From day of admission to day of hospital discharge to home |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAriel A. Salas, MD, MSPH
University of Alabama at Birmingham
Outcome results
None listed