Intermittent Hypoxia and Caffeine in Infants Born Preterm

PHASE2CompletedINTERVENTIONAL
Enrollment

170

Participants

Timeline

Start Date

January 18, 2019

Primary Completion Date

June 1, 2023

Study Completion Date

June 1, 2023

Conditions
Intermittent Hypoxia
Interventions
DRUG

Caffeine

Infants will be started on oral caffeine base at 5 mg/kg/day. At 36 weeks + 0 days PMA drug dose will be increased to 5 mg/kg BID (total daily dose 10 mg/kg). Dose will be weight-adjusted weekly until NICU (neonatal intensive care unit) discharge. After discharge, all new doses will be calculated from the last weight recorded prior to discharge. The research pharmacy will prepare a bulk oral solution with active drug (caffeine base). While in the hospital, a daily 24-hour supply will be prepared and dispensed. For home administration of study drug, the research pharmacy at each clinical site will prepare and dispense a sufficient quantity of caffeine base solution for outpatient treatment up to 42 weeks + 6 days.

DRUG

Placebos

SyrSpend SF Unflavored will be used as the placebo for the control group infants. The volume of the placebo will match the volume of the study drug.

Trial Locations (15)

19104

Children's Hospital of Philadelphia, Philadelphia

20010

Children's National Medical Center/Children's Research Institute, Washington D.C.

20889

Walter Reed National Military Medical Center, Bethesda

21224

Johns Hopkins Bayview Medical Center, Baltimore

21287

Johns Hopkins, Baltimore

32803

AdventHealth Orlando, Orlando

33701

Johns Hopkins All Children's Hospital, St. Petersburg

39216

University of Mississippi, Jackson

40536

University of Kentucky, Lexington

44195

Cleveland Clinic, Cleveland

92354

Loma Linda University Health System, Loma Linda

96826

Kapiolani Medical Center, Honolulu

02215

Beth Israel Deaconess Medical Center, Boston

01605

University of Massachusetss, Worcester

03756

Dartmouth Hitchcock Medical Center, Lebanon

All Listed Sponsors
collaborator

Boston University

OTHER

collaborator

Beth Israel Medical Center

OTHER

collaborator

University of Massachusetts, Worcester

OTHER

collaborator

American SIDS Institute

OTHER

collaborator

Walter Reed National Military Medical Center

FED

collaborator

Dartmouth-Hitchcock Medical Center

OTHER

collaborator

Children's Hospital of Philadelphia

OTHER

collaborator

Johns Hopkins All Children's Hospital

OTHER

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Children's National Research Institute

OTHER