Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial
- Registration Number
- NCT03340727
- Lead Sponsor
- NICHD Neonatal Research Network
- 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 of hospitalization after randomization.
- 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 citrate at 10 mg/kg/dose or placebo (equal volume of all the excipients except for the active ingredient, caffeine citrate) to be given daily beginning within 72 hours of open label caffeine discontinuation. The infant may still require hospitalization for observation after discontinuation of open label caffeine or for other discharge issues such as temperature control or feeding tolerance.
Once deemed ready for discharge, infants will be continued at home on the same dose of caffeine citrate or placebo for the first 28 days after hospital discharge. On the day of discharge, the parent will be supplied with 28 numbered vials with oral caffeine citrate (intervention group) or placebo at an equivalent volume (placebo group).
The parents will be educated by the research nurse, discharge nurse, physician, or pharmacist on storage and administration of study medication. A member of the research team will contact the parents to obtain post-discharge information within 72 hours after discharge, once a week for the first 4 weeks, and biweekly during the weeks 5 to 8 after discharge.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 827
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Caffeine Citrate 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 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.
- Primary Outcome Measures
Name Time Method Number of Days Between Randomization and Hospital Discharge Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA The number of days between randomization and hospital discharge. This outcome is censored at 48 weeks PMA and at time of transfer or death.
Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 4 Weeks Post-discharge Discharge through 4 weeks post-discharge Number of sick visits related to apneic or apparent life-threatening events within first 4 weeks post-discharge MEASTYPE=SEC
- Secondary Outcome Measures
Name Time Method The Number of Days to Apnea/ Bradycardia Free for 5 Consecutive Days Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA The number of days to apnea/ bradycardia free for 5 consecutive days. This outcome is censored at 48 weeks PMA
The Number of Days to Oral Feeds >140 ml/kg/Day or Growing on Less Than 140 ml/kg/Day for at Least 48 Hours Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA The number of days oral feeds \>140 ml/kg/day or growing on less than 140 ml/kg/day for at least 48 hours. This outcome is censored at 48 weeks PMA
Post-menstrual Age at Discharge Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA The post-menstrual age of the infant at discharge censored at 48 weeks PMA and at time of transfer or death
The Number of Days to Physiologic Maturity After Randomization Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA The number of days to physiologic maturity after randomization. Physiologic maturity is defined: 1. Temperature: out of the incubator for at least 48 hours with normal body temperature; 2. Feeding: oral feeding at a volume of at least 140 ml/kg for 48 hours or growing on less than 140 ml/kg/day for at least 48 hours; 3. Respiratory: apnea-free for at least 5 consecutive days. This outcome is censored at 48 weeks PMA
Weight Gain From Randomization Until Status Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA Weight gain from randomization until status %(discharge up to 48 wks PMA, with censoring at time of transfer or death%).
The Number of Days After Randomization Until Status That Infant Had at Least Two Consecutive Heart Rates >200 Documented at Least 3 Hours Apart Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA The number of days after randomization until status that infant had at least two consecutive heart rates \>200 documented at least 3 hours apart
Treatment for High Blood Pressure Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA Treatment for high blood pressure initiated after randomization until status.
The Number of Days to When Out of Incubator for 48 Hours: When Maintained Stable Temp for 48 Hrs Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA The number of days to when out of incubator for 48 hours: when maintained stable temp for 48 hrs. This outcome is censored at 48 weeks PMA
All-cause Mortality Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA All-cause mortality
Number of All-cause Readmissions Within First 4 Weeks Post-discharge Discharge through 4 weeks post-discharge Number of all-cause readmissions within first 4 weeks post-discharge
Number of All-cause Readmissions Within Second 4 Weeks Post-discharge 4 weeks through 8 weeks post-discharge Number of all-cause readmissions within second 4 weeks post-discharge
Number of All-cause Readmissions Within First 8 Weeks Post-discharge Discharge through 8 weeks post-discharge Number of all-cause readmissions within first 8 weeks post-discharge
Number of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within First 4 Weeks Post-discharge Discharge through 4 weeks post-discharge Number of all-cause sick visits, urgent care, emergency rooms, or health care provider%'s office, within first 4 weeks post-discharge
Number of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within Second 4 Weeks Post-discharge 4 weeks through 8 weeks post-discharge Number of all-cause sick visits, urgent care, emergency rooms, or health care provider%'s office, within second 4 weeks post-discharge
Number of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within First 8 Weeks Post-discharge Discharge through 8 weeks post-discharge Number of all-cause sick visits, urgent care, emergency rooms, or health care provider%'s office, within first 8 weeks post-discharge
Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within Second 4 Weeks Post-discharge 4 weeks through 8 weeks post-discharge Number of sick visits related to apneic or apparent life-threatening events within second 4 weeks post-discharge
Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 8 Weeks Post-discharge Discharge through 8 weeks post-discharge Number of sick visits related to apneic or apparent life-threatening events within first 8 weeks post-discharge
The Number of Episodes Between Randomization and Status That Infant Was Placed NPO for >= 24 Hours Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA The number of episodes between randomization and status that infant was placed NPO for \>= 24 hours
Use of Anti-reflux Medications Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA The use of anti-reflux medications started between randomization and status
Number of Days That Significant Apnea/Bradycardia Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA The number of days that significant apnea/bradycardia, as defined by documentation of infant receiving any of the following between randomization and status: open label caffeine, other methylxanthines, doxapram, CPAP or ventilatory support for apnea/bradycardia.
Trial Locations
- Locations (16)
Stanford University
🇺🇸Palo Alto, California, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Duke University
🇺🇸Durham, North Carolina, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
University of Rochester
🇺🇸Rochester, New York, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
RTI International
🇺🇸Durham, North Carolina, United States
Cincinnati Children's Medical Center
🇺🇸Cincinnati, Ohio, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Research Institute at Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Brown University, Women & Infants Hospital of Rhode Island
🇺🇸Providence, Rhode Island, United States