Premature; Infant, Light-for-dates
Conditions
Keywords
premature infant, early progressive feeding
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).
Interventions
OTHERProgressive Feeding with MEF
This group will receive minimal enteral feeds (MEF) with volumes of 20-24ml/kg/d for 4 days followed by daily increases in increments of 24-25ml/kg/d as tolerated until full enteral feeding is achieved.
OTHERProgressive Feeding without MEF
This group will receive feeding volumes of 20-24ml/kg/d of day 1 of feeding followed by the study intervention of daily volume increases in increments of 24-25ml/kg/d as tolerated until full enteral feeding is achieved.
Sponsors
The Gerber Foundation
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Hours to 48 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of days alive and receiving full enteral feeding | birth to 28 days | number of days alive on full enteral feeding in the first 28 days after birth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with diagnosis of intestinal perforation | birth to 14 days | — |
| Death | birth to 120 days | death prior to 121 days of birth |
| Number of days alive and receiving full enteral feeding according to time of exposure to human milk and formula feeding the first 28 days | birth to 28 days | — |
| Time to establish full enteral feeding | birth to 28 days | time interval between birth and full enteral feeding at 120cc/kg/day |
| Number of episodes of feeding intolerance | birth to 28 days | interruption or cessation of enteral feeds for a period greater than 12 hours for abnormal abdominal examination |
| Number of episodes of feeding intolerance resulting in an interruption or cessation of progressive enteral feeding for a period < 12 hours | birth to 28 days | — |
| Number of participants with diagnosis of necrotizing enterocolitis | birth to 120 days or discharge, whichever occurs first | diagnosis of necrotizing enterocolitis stage 2 or 3 |
| Number of days requiring central line access | birth to 28 days | — |
| Number of episodes of culture proven sepsis | birth to 120 days or discharge, whichever occurs first | — |
| Growth/length at time of discharge | birth to 120 days or discharge, whichever occurs first | — |
| Duration of hospital stay in days | birth to 120 days or discharge, whichever occurs first | — |
| Changes in intestinal microbiome | birth to 28 days | Determined by molecular analyses of bacteria in fecal samples |
| Number of days receiving parenteral nutrition | birth to 28 days | — |
Countries
United States
Outcome results
None listed