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

Premature; Infant, Light-for-dates Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02915549
• Other study ID #: F160609004
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: November 2022

Study information

• Verified date: December 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2022
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Hours to 48 Hours

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Premature; Infant, Light-for-dates

Intervention

Other:
• 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
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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	The Gerber Foundation

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. 2022 Nov 28:1-6. doi: 10.1159/00052 — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days alive and receiving full enteral feeding	number of days alive on full enteral feeding in the first 28 days after birth	birth to 28 days
Secondary	Number of participants with diagnosis of necrotizing enterocolitis	diagnosis of necrotizing enterocolitis stage 2 or 3	birth to 120 days or discharge, whichever occurs first
Secondary	Number of participants with diagnosis of intestinal perforation		birth to 14 days
Secondary	Death	death prior to 121 days of birth	birth to 120 days
Secondary	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
Secondary	Time to establish full enteral feeding	time interval between birth and full enteral feeding at 120cc/kg/day	birth to 28 days
Secondary	Number of episodes of feeding intolerance	interruption or cessation of enteral feeds for a period greater than 12 hours for abnormal abdominal examination	birth to 28 days
Secondary	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
Secondary	Number of days receiving parenteral nutrition		birth to 28 days
Secondary	Number of days requiring central line access		birth to 28 days
Secondary	Number of episodes of culture proven sepsis		birth to 120 days or discharge, whichever occurs first
Secondary	Growth/length at time of discharge		birth to 120 days or discharge, whichever occurs first
Secondary	Duration of hospital stay in days		birth to 120 days or discharge, whichever occurs first
Secondary	Changes in intestinal microbiome	Determined by molecular analyses of bacteria in fecal samples	birth to 28 days