Trial · NCT03340727
Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial
NCT03340727, Phase 3, Terminated, NICHD Neonatal Research Network; results first posted 2024-06-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial. Trials, record NCT03340727. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03340727
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial
- NCT number
- NCT03340727
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 827 participants, actual
- Lead sponsor
- NICHD Neonatal Research Network
- Conditions
- Apnea of Prematurity
- Interventions
- Caffeine Citrate, Placebo
- First posted
- 2017-11-13
- Last updated
- 2024-07-31
- Results first posted
- 2024-06-28
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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 | 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 |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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%). |
| Secondary | 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 |
| Secondary | 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. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Days Between Randomization and Hospital Discharge | Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | days | MEDIAN |
| SECONDARY | The Number of Days to Physiologic Maturity After Randomization | Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | days | MEDIAN |
| SECONDARY | 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 | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | days | MEDIAN |
| SECONDARY | 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 | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | days | MEDIAN |
| SECONDARY | 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 | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | days | MEDIAN |
| SECONDARY | Post-menstrual Age at Discharge | Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | weeks | MEAN |
| SECONDARY | Weight Gain From Randomization Until Status | Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | grams per day | MEAN |
| SECONDARY | 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 | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | days | MEDIAN |
| SECONDARY | Treatment for High Blood Pressure | Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | episodes | MEDIAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Days Between Randomization and Hospital Discharge | Caffeine | 18 | Inter-Quartile Range 10 to 30 | days | |
| Number of Days Between Randomization and Hospital Discharge | Placebo | 16.5 | Inter-Quartile Range 10 to 27 | days | |
| The Number of Days to Physiologic Maturity After Randomization | Caffeine | 13 | Inter-Quartile Range 7 to 23 | days | |
| The Number of Days to Physiologic Maturity After Randomization | Placebo | 14 | Inter-Quartile Range 8 to 23 | days | |
| The Number of Days to When Out of Incubator for 48 Hours: When Maintained Stable Temp for 48 Hrs | Caffeine | 5 | Inter-Quartile Range 2 to 9 | days | |
| The Number of Days to When Out of Incubator for 48 Hours: When Maintained Stable Temp for 48 Hrs | Placebo | 5 | Inter-Quartile Range 1 to 9 | days | |
| The Number of Days to Apnea/ Bradycardia Free for 5 Consecutive Days | Caffeine | 8 | Inter-Quartile Range 5 to 16 | days | |
| The Number of Days to Apnea/ Bradycardia Free for 5 Consecutive Days | Placebo | 11 | Inter-Quartile Range 5 to 18 | days | |
| 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 | Caffeine | 14 | Inter-Quartile Range 6 to 23 | days | |
| 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 | Placebo | 12 | Inter-Quartile Range 5 to 22 | days |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Caffeine Citrate | 416 | |
| Overall Study | STARTED | Placebo | 411 | |
| Overall Study | Completed In-hospital Stay | Caffeine Citrate | 390 | |
| Overall Study | Completed In-hospital Stay | Placebo | 397 | |
| Overall Study | COMPLETED | Caffeine Citrate | 345 | |
| Overall Study | COMPLETED | Placebo | 351 | |
| Overall Study | NOT COMPLETED | Caffeine Citrate | 71 | |
| Overall Study | NOT COMPLETED | Placebo | 60 |
Source ClinicalTrials.gov
Adverse events68
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Arrhythmia neonatal | Cardiac disorders | Caffeine | 1 | 416 | 1 |
| other | Arrhythmia neonatal | Cardiac disorders | Placebo | 0 | 411 | 0 |
| other | Haematochezia | Gastrointestinal disorders | Caffeine | 0 | 416 | 0 |
| other | Haematochezia | Gastrointestinal disorders | Placebo | 1 | 411 | 1 |
| other | Necrotising enterocolitis neonatal | Gastrointestinal disorders | Caffeine | 0 | 416 | 0 |
| other | Necrotising enterocolitis neonatal | Gastrointestinal disorders | Placebo | 2 | 411 | 2 |
| other | Sepsis neonatal | Infections and infestations | Caffeine | 0 | 416 | 0 |
| other | Sepsis neonatal | Infections and infestations | Placebo | 2 | 411 | 2 |
| other | Apnea neonatal | Respiratory, thoracic and mediastinal disorders | Caffeine | 1 | 416 | 1 |
| other | Apnea neonatal | Respiratory, thoracic and mediastinal disorders | Placebo | 9 | 411 | 10 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Caffeine | 1 | 416 |
| Total, all-cause mortality | Placebo | 0 | 411 |
| Total, other adverse events | Caffeine | 10 | 416 |
| Total, other adverse events | Placebo | 24 | 411 |
| Total, serious adverse events | Caffeine | 12 | 416 |
| Total, serious adverse events | Placebo | 22 | 411 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40294395 | DERIVED |
Source PubMed
Grants16
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| UG1HD021364 | NICHD Neonatal Research Network Clinical Center - Case Western Reserve University | HIBBS, ANNA MARIA | CASE WESTERN RESERVE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD027851 | NICHD Neonatal Research Network | PATEL, RAVI MANGAL | EMORY UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD027853 | NICHD Neonatal Research Network -- Cincinnati Clinical Center | MERHAR, STEPHANIE L | CINCINNATI CHILDRENS HOSP MED CTR | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD027880 | NICHD Neonatal Research Network - Stanford University | CHOCK, VALERIE | STANFORD UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD034216 | NICHD Neonatal Research Network Clinical Center UAB | CARLO FONT, WALDEMAR A. | UNIVERSITY OF ALABAMA AT BIRMINGHAM | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD040492 | North Carolina Clinical Center | COTTEN, CHARLES MICHAEL; LAUGHON, MATTHEW; MOORE, RYAN THOMAS | DUKE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD040689 | NICHD COPPERATIVE MULTICENTER NEONATAL RESEARCH NETWORK | WYCKOFF, MYRA HELEN | UT SOUTHWESTERN MEDICAL CENTER | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD053089 | Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal ResearchNetwork | FULLER, JANELL | UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD053109 | NICHD Cooperative Multicenter Neonatal Research Network | COLAIZY, TARAH TRINITY | UNIVERSITY OF IOWA | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD068244 | Clinical Center for NICHD/Neonatal Research Network | DEMAURO, SARA BONAMO; EICHENWALD, ERIC C | UNIVERSITY OF PENNSYLVANIA | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
1 to 10 of 16
See all 16 grantsTrial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Caffeine vs Placebo: deaths from any cause | Trial comparisons |
| Caffeine vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03340727
GET https://conductscience.org/api/trials/v1/NCT03340727/registered?page=2