Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial (NCT03340727) | Clinical Trial Compass
TerminatedPhase 3
Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial
Stopped: Futility
United States827 participantsStarted 2019-02-27
Plain-language 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.
Who can participate
Age range
29 Weeks – 33 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Days Between Randomization and Hospital Discharge
Timeframe: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
2
Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 4 Weeks Post-discharge
Timeframe: Discharge through 4 weeks post-discharge