Clinical trial NCT02915549: Early Progressive Feeding in Human-Milk Fed Extremely Preterm Infants: A Randomized Trial
Official title: Early Progressive Feeding in Human-Milk Fed Extremely Preterm Infants: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature; Infant, Light-for-dates
Keywords: premature infant
early progressive feeding
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: The Gerber Foundation
First posted: 2016-09-27
Enrollment: 60
Sex: ALL
Minimum age (years): 24
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To test the hypothesis that progressive feeding without minimal enteral feeding (MEF) compared to progressive feeding preceded by a 4-day course of MEF will result in an increased number of days alive on full enteral feeding in the first 28 days after birth in extremely preterm infants receiving human milk.

Detailed description: Qualifying participants will be randomly assigned to one of two study groups: 1) Early progressive feeding without MEF or 2) Progressive feedings preceded by 4 days of MEF. Regardless of study group assignment, donor human milk will be offered if not enough of the mother's expressed breastmilk during the intervention phase of the trial.

Intervention group: Progressive feeding of 20-24 ml/kg/d on day 1 of feeding, followed by daily increments of 24-25 ml/kg/d as tolerated until full enteral feeding achieved.

Control group: MEF with feeding volumes of 20-24 ml/kg/d for 4 days followed by progressive feeding (daily increments of 24-25 ml/kg/d) as tolerated until full enteral feeding achieved.

Both groups will receive fast progressive feeding (\>/= 24 ml/kg/day)

If parent agrees, stool "dirty" diapers will be collected 5 times (at birth, 1, 2, 3 and 4 weeks of life).

Eligibility criteria: Inclusion Criteria:

* admission to the NICU within 48 hours with gestational age between 22.0 and 28.6 weeks

Exclusion Criteria:

* small for gestational age (\<10th percentile birthweight), major congenital or chromosomal anomalies, and infants with terminal illness in which decision to withhold or limit support have been made

Primary outcomes:
measure: Number of days alive and receiving full enteral feeding
timeFrame: birth to 28 days
Secondary outcomes:
measure: Number of participants with diagnosis of necrotizing enterocolitis
timeFrame: birth to 120 days or discharge, whichever occurs first
measure: Number of participants with diagnosis of intestinal perforation
timeFrame: birth to 14 days
measure: Death
timeFrame: birth to 120 days
measure: Number of days alive and receiving full enteral feeding according to time of exposure to human milk and formula feeding the first 28 days
timeFrame: birth to 28 days
measure: Time to establish full enteral feeding
timeFrame: birth to 28 days
measure: Number of episodes of feeding intolerance
timeFrame: birth to 28 days
measure: Number of episodes of feeding intolerance resulting in an interruption or cessation of progressive enteral feeding for a period < 12 hours
timeFrame: birth to 28 days
measure: Number of days receiving parenteral nutrition
timeFrame: birth to 28 days
measure: Number of days requiring central line access
timeFrame: birth to 28 days
measure: Number of episodes of culture proven sepsis
timeFrame: birth to 120 days or discharge, whichever occurs first
measure: Growth/length at time of discharge
timeFrame: birth to 120 days or discharge, whichever occurs first
measure: Duration of hospital stay in days
timeFrame: birth to 120 days or discharge, whichever occurs first
measure: Changes in intestinal microbiome
timeFrame: birth to 28 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Ariel A. Salas, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salas AA, Li P, Parks K, Lal CV, Martin CR, Carlo WA. Early progressive feeding in extremely preterm infants: a randomized trial. Am J Clin Nutr. 2018 Mar 1;107(3):365-370. doi: 10.1093/ajcn/nqy012.
citation: Salas AA, Willis KA, Carlo WA, Yi N, Zhang L, Van Der Pol WJ, Younge NE, Lefkowitz EJ, Lal CV. The gut microbiome of extremely preterm infants randomized to the early progression of enteral feeding. Pediatr Res. 2022 Sep;92(3):799-804. doi: 10.1038/s41390-021-01831-w. Epub 2021 Nov 13.
citation: Durham L, Gunawan E, Nguyen K, Reeves A, Shukla V, Salas AA. Total Fluid Administration and Weight Loss during the First 2 Weeks in Infants Randomized to Early Enteral Feeding after Extremely Preterm Birth. Neonatology. 2023;120(2):257-262. doi: 10.1159/000527430. Epub 2022 Nov 28.