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

The University of Alabama at Birmingham

Status: Completed

Conditions: Premature; Infant, Light-for-dates

Treatments: Other: Progressive Feeding with MEF; Other: Progressive Feeding without MEF

Study type: Interventional

Funder types: Other

Identifiers

NCT02915549

F160609004

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 24 to 48 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Progressive Feeding without MEF

Experimental group

Description:

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.

Treatment:

Other: Progressive Feeding without MEF

Progressive Feeding with MEF

Active Comparator group

Description:

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.

Treatment:

Other: Progressive Feeding with MEF