Early Progressive Feeding in Human-Milk Fed Extremely Preterm Infants: A Randomized Trial

Not Applicable

Completed

• Conditions: Premature; Infant, Light-for-dates
• Interventions: Other: Progressive Feeding without MEF; Other: Progressive Feeding with MEF

• Registration Number: NCT02915549
• Lead Sponsor: University of Alabama at Birmingham

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).

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-19
• Study First Submitted QC: 2016-09-23
• Study First Posted: 2016-09-27
• Primary Completion: 2017-10
• Study Completion: 2022-11
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-13
• Last Update Posted: 2022-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Progressive Feeding without MEF	Progressive 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.
Progressive Feeding with MEF	Progressive 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 days receiving parenteral nutrition	birth to 28 days
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

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States