Trial · NCT01020357
Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study
NCT01020357, Phase 3, Completed, McMaster University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study. Trials, record NCT01020357. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01020357
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study
- NCT number
- NCT01020357
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 201 participants, actual
- Lead sponsor
- McMaster University
- Conditions
- Apnea of Prematurity
- Interventions
- Caffeine citrate injection, placebo
- First posted
- 2009-11-25
- Last updated
- 2014-12-05
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Aim 1: The primary outcome is the mean actual sleep time as measured by actigraphy, between subjects who received caffeine vs placebo. | 5-7 years | |
| Primary | Aim 2: The primary outcome is the apnea hypopnea index (AHI) between subjects who received caffeine vs placebo. | 5-7 years | |
| Primary | Aim 3: The primary outcome is the correlation between full-scale IQ from the Wechsler Preschool and Primary Scale of Intelligence (measured in the CAP trial rather than directly from this protocol), sleep time and AHI. | 5-7 years | |
| Secondary | Questionnaire data: National Sleep Foundation (NSF) and Pediatric Sleep Questionnaire (PSQ) scores | 5-7 years | |
| Secondary | Polysomnography data: Sleep architecture, arousal index, central apnea index, SpO2 and periodic limb movement index. | 5-7 years |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
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 |
|---|---|---|---|---|---|
| R01HL098045 | Long-term effects of caffeine therapy for apnea of prematurity on sleep disorders | MARCUS, CAROLE L | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2009 to 2012 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01020357
GET https://conductscience.org/api/trials/v1/NCT01020357/registered