Status:
TERMINATED
Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial
Lead Sponsor:
NICHD Neonatal Research Network
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Apnea of Prematurity
Eligibility:
All Genders
29-33 years
Phase:
PHASE3
Brief 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...
Detailed Description
Study subjects will be patients in the NICU at one of the participating hospitals at a Neonatal Research Network site. Infants who meet the eligibility criteria will be randomized to either caffeine c...
Eligibility Criteria
Inclusion
- 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
Exclusion
- On respiratory therapy (oxygen more than room air equivalent for high altitude sites, nasal cannula, continuous positive pressure ventilation, and/or mechanical ventilation)
- Infants who would otherwise be discharged home on apnea monitor due to underlying disease or family history, including history of a sibling with sudden infant death syndrome
- Parental request for apnea monitor
- Congenital heart disease other than atrial septal defect, ventricular septal defect, or patent ductus arteriosus
- Neuromuscular conditions affecting respiration
- Major congenital malformation and/or genetic disorder
- Plans to transfer to a non-NRN site before discharge
- Unable to obtain parental or guardian consent
Key Trial Info
Start Date :
February 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2023
Estimated Enrollment :
827 Patients enrolled
Trial Details
Trial ID
NCT03340727
Start Date
February 27 2019
End Date
March 20 2023
Last Update
July 31 2024
Active Locations (16)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Stanford University
Palo Alto, California, United States, 94304
3
Emory University
Atlanta, Georgia, United States, 30303
4
University of Iowa
Iowa City, Iowa, United States, 52242