Study Stopped
Futility
Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial
MoCHA
Randomized Controlled Trial of Home Therapy With Caffeine Citrate in Moderately Preterm Infants With Apnea of Prematurity
17 other identifiers
interventional
827
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2019
Typical duration for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2017
CompletedFirst Posted
Study publicly available on registry
November 13, 2017
CompletedStudy Start
First participant enrolled
February 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2023
CompletedResults Posted
Study results publicly available
June 28, 2024
CompletedJuly 31, 2024
July 1, 2024
3.9 years
November 3, 2017
May 7, 2024
July 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Days Between Randomization and Hospital Discharge
The number of days between randomization and hospital discharge. This outcome is censored at 48 weeks PMA and at time of transfer or death.
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 4 Weeks Post-discharge
Number of sick visits related to apneic or apparent life-threatening events within first 4 weeks post-discharge MEASTYPE=SEC
Discharge through 4 weeks post-discharge
Secondary Outcomes (20)
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 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 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 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
Post-menstrual Age at Discharge
Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
- +15 more secondary outcomes
Study Arms (2)
Caffeine Citrate
EXPERIMENTALCaffeine 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 COMPARATORPlacebo 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.
Interventions
The study intervention is caffeine citrate given once daily at 10 mg/kg/day. It is given orally, before hospital discharge and 28 days after discharge.
The study intervention is placebo given once daily at a volume equivalent to 10 mg/kg of caffeine citrate. It is given orally, before hospital discharge and 28 days after discharge.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Stanford University
Palo Alto, California, 94304, United States
Emory University
Atlanta, Georgia, 30303, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
University of Rochester
Rochester, New York, 14642, United States
RTI International
Durham, North Carolina, 27705, United States
Duke University
Durham, North Carolina, 27710, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84108, United States
Related Publications (1)
Carlo WA, Eichenwald EC, Carper BA, Bell EF, Keszler M, Patel RM, Sanchez PJ, Goldberg RN, D'Angio CT, Van Meurs KP, Hibbs AM, Ambalavanan N, Cosby SS, Newman NS, Vohr BR, Walsh MC, Das A, Ohls RK, Fuller J, Rysavy MA, Ghavam S, Brion LP, Puopolo KM, Moore R, Baack ML, Colaizy TT, Baserga M, Osman AF, Merhar SL, Poindexter BB, DeMauro SB, Kumar V, Cotten CM; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Extended Caffeine for Apnea in Moderately Preterm Infants: The MoCHA Randomized Clinical Trial. JAMA. 2025 Jun 24;333(24):2154-2163. doi: 10.1001/jama.2025.5791.
PMID: 40294395DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Abhik Das
- Organization
- RTI International
Study Officials
- PRINCIPAL INVESTIGATOR
Waldemar Carlo, MD
University of Alabama at Birmingham
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2017
First Posted
November 13, 2017
Study Start
February 27, 2019
Primary Completion
January 23, 2023
Study Completion
March 20, 2023
Last Updated
July 31, 2024
Results First Posted
June 28, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
Per NIH Data Sharing Plan