Limited Versus Extended Trophic Feeding (LET-FEED) Trial

PHASE3RecruitingINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

July 3, 2025

Primary Completion Date

January 1, 2028

Study Completion Date

March 31, 2028

Conditions
SepsisLength of StayMortality
Interventions
OTHER

Limited Trophic Feeds (1 day of trophic feeds)

Advancing enteral feeds after 1 day of trophic feeds of 20-25 mL/kg birthweight/day. Advancement of enteral feeds will be by approximately 30 mL/kg birthweight/day until achieving at least 140 mL/kg birthweight/day of enteral feeds. Enteral feeds will consist of parent's own milk or donor human milk.

OTHER

Extended Trophic Feeds (3 days of trophics)

Advancing enteral feeds after 3 days of trophic feeds of 20-25 mL/kg birthweight/day. Advancement of enteral feeds will be by approximately 30 mL/kg birthweight/day after 3 days of trophic feeds. Advancement will occur until achieving at least 140 mL/kg birthweight/day of enteral feeds. Enteral feeds will consist of parent's own milk or donor human milk.

Trial Locations (6)

33606

NOT_YET_RECRUITING

University of South Florida, Tampa

35233

NOT_YET_RECRUITING

University of Alabama at Birmingham, Birmingham

73104

NOT_YET_RECRUITING

University of Oklahoma, Oklahoma City

77030

NOT_YET_RECRUITING

Baylor College of Medicine, Houston

98195

NOT_YET_RECRUITING

University of Washington, Seattle

98405

RECRUITING

St. Joseph's Medical Center, Tacoma

All Listed Sponsors
collaborator

University of Alabama at Birmingham

OTHER

collaborator

Baylor College of Medicine

OTHER

collaborator

University of South Florida

OTHER

collaborator

University of Oklahoma

OTHER

collaborator

St. Joseph's Medical Center

UNKNOWN

lead

University of Washington

OTHER