Apnea of PrematurityPhase 3MoCHANCT03340727
Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial
A Phase 3 study testing Caffeine Citrate in people with Apnea of Prematurity, run by NICHD Neonatal Research Network at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 29 to 33 weeks
- Conditions the study is for
- Apnea of Prematurity
- What is being tested?
- Caffeine Citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 827 participants
- Where
- 16 sitesUnited States
- Study dates
- 27 Feb 2019to 20 Mar 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 to 33 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
University of New Mexico
Albuquerque, New Mexico, 87131
Emory University
Atlanta, Georgia, 30303
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
RTI International
Durham, North Carolina, 27705
Duke University
Durham, North Carolina, 27710
University of Texas Health Science Center at Houston
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Stanford University
Palo Alto, California, 94304
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
University of Rochester
Rochester, New York, 14642
University of Utah
Salt Lake City, Utah, 84108
About this study
Official title: Randomized Controlled Trial of Home Therapy With Caffeine Citrate in Moderately Preterm Infants With Apnea of Prematurity
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.
Read the 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.
- Conditions
- Apnea of Prematurity
- Being tested
- Caffeine Citrate, Placebo
- Keywords
- Moderate preterm infant, Caffeine citrate
- Medical subject headings
- Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine CitrateDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Caffeine Citrate | Experimental | 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. Receives: Drug: Caffeine Citrate |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Discharge through 4 weeks post-discharge
Secondary outcomes (20)
The Number of Days to Physiologic Maturity After Randomization
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
Measured: 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
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
Measured: 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
The number of days to apnea/ bradycardia free for 5 consecutive days. This outcome is censored at 48 weeks PMA
Measured: 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
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
Measured: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Post-menstrual Age at Discharge
The post-menstrual age of the infant at discharge censored at 48 weeks PMA and at time of transfer or death
Measured: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Weight Gain From Randomization Until Status
Weight gain from randomization until status %(discharge up to 48 wks PMA, with censoring at time of transfer or death%).
Measured: 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
The number of days after randomization until status that infant had at least two consecutive heart rates >200 documented at least 3 hours apart
Measured: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Treatment for High Blood Pressure
Treatment for high blood pressure initiated after randomization until status.
Measured: 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
The number of episodes between randomization and status that infant was placed NPO for >= 24 hours
Measured: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Use of Anti-reflux Medications
The use of anti-reflux medications started between randomization and status
Measured: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Number of Days That Significant Apnea/Bradycardia
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.
Measured: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
All-cause Mortality
All-cause mortality
Measured: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Number of All-cause Readmissions Within First 4 Weeks Post-discharge
Number of all-cause readmissions within first 4 weeks post-discharge
Measured: Discharge through 4 weeks post-discharge
Number of All-cause Readmissions Within Second 4 Weeks Post-discharge
Number of all-cause readmissions within second 4 weeks post-discharge
Measured: 4 weeks through 8 weeks post-discharge
Number of All-cause Readmissions Within First 8 Weeks Post-discharge
Number of all-cause readmissions within first 8 weeks post-discharge
Measured: Discharge through 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
Number of all-cause sick visits, urgent care, emergency rooms, or health care provider%'s office, within first 4 weeks post-discharge
Measured: Discharge through 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
Number of all-cause sick visits, urgent care, emergency rooms, or health care provider%'s office, within second 4 weeks post-discharge
Measured: 4 weeks 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 all-cause sick visits, urgent care, emergency rooms, or health care provider%'s office, within first 8 weeks post-discharge
Measured: Discharge 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 second 4 weeks post-discharge
Measured: 4 weeks through 8 weeks post-discharge
Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 8 Weeks Post-discharge
Number of sick visits related to apneic or apparent life-threatening events within first 8 weeks post-discharge
Measured: Discharge through 8 weeks post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start27 Feb 2019
- Primary completion23 Jan 2023
- Study completion20 Mar 2023
Why it stopped: Futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Apnea of PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 827 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Neonatal Research Network
- Sponsor type
- Research network
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Waldemar Carlo, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340727
- Sponsor's protocol ID
- NICHD-NRN-0056
- Other IDs
- UG1HD034216, UG1HD027904, UG1HD021364, UG1HD027853, UG1HD040689, UG1HD040492, UG1HD027851, UG1HD087229
- Acronym
- MoCHA
- Status last verified
- Jul 2024
- First submitted
- 3 Nov 2017
- Last updated
- 31 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Per NIH Data Sharing Plan
Publications
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.
PubMed 40294395
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Home Therapy With Caffeine Citrate in Moderately Preterm Infants With Apnea of Prematurity
- ClinicalTrials.gov ID
- NCT03340727
- Acronym / sponsor ID
- MoCHA / NICHD-NRN-0056
- Conditions
- Apnea of Prematurity
- Keywords
- Moderate preterm infant, Caffeine citrate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 827 participants (actual)
- Lead sponsor
- NICHD Neonatal Research NetworkResearch network
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Posted 28 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Caffeine Citrate | Experimental | Drug: Caffeine CitrateCaffeine 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 comparator | Drug: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 29 to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine CitrateThe 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. | Drug | Caffeine Citrate |
| PlaceboThe 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. | Drug | Placebo |
Primary outcome
Number of Days Between Randomization and Hospital Discharge
Time frame: 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
Time frame: 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
20 secondary outcomes
The Number of Days to Physiologic Maturity After Randomization
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Post-menstrual Age at Discharge
Time frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Weight Gain From Randomization Until Status
Time frame: 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
Time frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Treatment for High Blood Pressure
Time frame: 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
Time frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Use of Anti-reflux Medications
Time frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Number of Days That Significant Apnea/Bradycardia
Time frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
All-cause Mortality
Time frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
Number of All-cause Readmissions Within First 4 Weeks Post-discharge
Time frame: Discharge through 4 weeks post-discharge
Number of All-cause Readmissions Within Second 4 Weeks Post-discharge
Time frame: 4 weeks through 8 weeks post-discharge
Number of All-cause Readmissions Within First 8 Weeks Post-discharge
Time frame: Discharge through 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
Time frame: Discharge through 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
Time frame: 4 weeks 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
Time frame: Discharge through 8 weeks post-discharge
Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within Second 4 Weeks Post-discharge
Time frame: 4 weeks through 8 weeks post-discharge
Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 8 Weeks Post-discharge
Time frame: Discharge through 8 weeks post-discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40294395Carlo 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.
- Individual participant dataSharing planned: Yes. Per NIH Data Sharing Plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waldemar Carlo, MD principal investigator
University of Alabama at Birmingham
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Caffeine Citrate in people with Apnea of Prematurity, run by NICHD Neonatal Research Network at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Days Between Randomization and Hospital Discharge (time frame: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03340727, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.