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Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial
Not Recruiting
Trial ID: NCT03340727
Purpose
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.
Official Title
Randomized Controlled Trial of Home Therapy With Caffeine Citrate in Moderately Preterm Infants With Apnea of Prematurity
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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
Intervention(s):
drug: Caffeine Citrate
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Krisa P Van Meurs, MD