Randomized Controlled Trial of Home Therapy With Caffeine Citrate in Moderately Preterm Infants With Apnea of Prematurity
Who is this study for? Moderately preterm infants with resolved apnea of prematurity
What treatments are being studied? Caffeine Citrate
Status: Terminated
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The objective of this study is to evaluate the effect of continuing treatment with caffeine citrate in the hospital and at home in moderately preterm infants with resolved apnea of prematurity on days of hospitalization after randomization.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 7 months
Healthy Volunteers: f
View:
• Inborn and outborn infants of 29 0/7 to 33 6/7 weeks gestational age at birth
• admitted to hospitals of the NICHD NRN who, are at time of enrollment:
• ≤35 6/7 weeks post-menstrual age at the time of randomization
• Receiving caffeine with plan to discontinue treatment or just discontinued caffeine treatment
• Receiving feeds at a volume of ≥120 ml/kg/day by oral and/or tube feeding
• Ability to start study medication within 72 hours after stopping caffeine
Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
California
Stanford University
Palo Alto
Georgia
Emory University
Atlanta
Iowa
University of Iowa
Iowa City
North Carolina
Duke University
Durham
RTI International
Durham
New Mexico
University of New Mexico
Albuquerque
New York
University of Rochester
Rochester
Ohio
Cincinnati Children's Medical Center
Cincinnati
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland
Research Institute at Nationwide Children's Hospital
Columbus
Pennsylvania
University of Pennsylvania
Philadelphia
Rhode Island
Brown University, Women & Infants Hospital of Rhode Island
Providence
Texas
University of Texas Southwestern Medical Center at Dallas
Dallas
University of Texas Health Science Center at Houston
Houston
Utah
University of Utah
Salt Lake City
Time Frame
Start Date: 2019-02-27
Completion Date: 2023-03-20
Participants
Target number of participants: 827
Treatments
Experimental: Caffeine Citrate
Caffeine citrate at 10 mg/kg/dose (5 mg/kg caffeine base) daily, in hospital. Infants will continue at home on the same dose of caffeine citrate for the first 28 days after hospital discharge.
Placebo_comparator: Placebo
Placebo contains all of the excipients except for the active ingredient, caffeine citrate, (a volume equivalent to 10 mg/kg of caffeine citrate) and given daily. Infants will be continued at home on the same dose of placebo for the first 28 days after hospital discharge.
Related Therapeutic Areas
Sponsors
Leads: NICHD Neonatal Research Network
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)