Randomized Controlled Trial of Home Therapy With Caffeine Citrate in Moderately Preterm Infants With Apnea of Prematurity

NICHD-NRN-0056

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.

2019-02-27

2023-03-01

2023-03-01

Active (not recruiting)

Early phase I

800

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Sample size for this trial will be flexible: the trial will be stopped for efficacy or futility based on pre-determined statistical thresholds or based on study drug availability.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 800, 'type': 'ESTIMATED'}}

2023-02-10