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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
60
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.
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.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Number of days alive and receiving full enteral feeding
number of days alive on full enteral feeding in the first 28 days after birth
Time frame: birth to 28 days
Number of participants with diagnosis of necrotizing enterocolitis
diagnosis of necrotizing enterocolitis stage 2 or 3
Time frame: birth to 120 days or discharge, whichever occurs first
Number of participants with diagnosis of intestinal perforation
Time frame: birth to 14 days
Death
death prior to 121 days of birth
Time frame: birth to 120 days
Number of days alive and receiving full enteral feeding according to time of exposure to human milk and formula feeding the first 28 days
Time frame: birth to 28 days
Time to establish full enteral feeding
time interval between birth and full enteral feeding at 120cc/kg/day
Time frame: birth to 28 days
Number of episodes of feeding intolerance
interruption or cessation of enteral feeds for a period greater than 12 hours for abnormal abdominal examination
Time frame: birth to 28 days
Number of episodes of feeding intolerance resulting in an interruption or cessation of progressive enteral feeding for a period < 12 hours
Time frame: birth to 28 days
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Number of days receiving parenteral nutrition
Time frame: birth to 28 days
Number of days requiring central line access
Time frame: birth to 28 days
Number of episodes of culture proven sepsis
Time frame: birth to 120 days or discharge, whichever occurs first
Growth/length at time of discharge
Time frame: birth to 120 days or discharge, whichever occurs first
Duration of hospital stay in days
Time frame: birth to 120 days or discharge, whichever occurs first
Changes in intestinal microbiome
Determined by molecular analyses of bacteria in fecal samples
Time frame: birth to 28 days