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NCT00182312 · ClinicalTrials.gov registry record · Phase 3
Caffeine for Apnea of Prematurity (CAP)
A Phase 3 study of Apnea of Prematurity, sponsored by McMaster University.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,000
- Enrollment target
- 20
- Study locations
NCT00182312: Completed Phase 3 study of Apnea of Prematurity, sponsored by McMaster University.
NCT00182312 is a Phase 3 study of Apnea of Prematurity that has completed, run by McMaster University. The registered enrollment target is 2,000 participants, above the 75-participant average among 6 other Apnea of Prematurity trials with a reported enrollment target (2567% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00182312, a Phase 3 study of Apnea of Prematurity, has completed, sponsored by McMaster University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,000 participants
- Enrollment target
- 20
- Study locations
Study Summary
At least 5 of every 1000 live-born babies are very premature and weigh only 500 to 1250 grams at birth. Approximately 30-40% of these high-risk infants either die or survive with lasting disabilities. The aim of this research is to reduce this heavy burden of illness. A multi-center randomized controlled trial has been designed in which 2000 very low birth weight infants will be enrolled. Our goal is to determine whether the avoidance of methylxanthine drugs will improve survival without disability to 18 months, corrected for prematurity. Methylxanthine drugs such as caffeine are used to prevent or treat periodic breathing and breath-holding spells in premature infants. However, there is a striking lack of evidence for the long-term efficacy and safety of this therapy. Methylxanthines block a naturally occurring substance, called adenosine, which protects the brain during episodes of oxygen deficiency. Such episodes are common in infants who are treated with methylxanthines. It is possible that methylxanthines may worsen the damage caused by lack of oxygen. Therefore, this trial will clarify whether methylxanthines cause more good than harm in very low birth weight infants.
Conditions Studied
Interventions
- DRUG Caffeine citrate injection
Study Locations (20)
Ontario
- McMaster University - Hamilton
- Kingston General Hospital - Kingston
- Ottawa Hospital - Ottawa
- Mount Sinai Hospital - Toronto
- Sunnybrook & Women's College Health Science Centre - Toronto
- Windsor Regional Hospital - Windsor
Victoria
- Mercy Hospital for Women - Melbourne
- Royal Women's Hospital - Melbourne
British Columbia
- Children's & Women's Health Centre of BC - Vancouver
- Victoria General Hospital - Victoria
Quebec
- Royal Victoria Hospital - Montreal
- University of Sherbrooke - Sherbrooke
New York
- Brooklyn Hospital Center - Brooklyn
Australian Capital Territory
- Canberra Hospital - Canberra
South Australia
- Women's & Children's Hospital - Adelaide
Alberta
- Foothills Hospital - Calgary
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 1999-10 |
| Est. Completion | 2016-07 |
| Phase | Phase 3 |
What the finished NCT00182312 record still lists
NCT00182312 is an interventional study that assigns participants to a tested intervention. Its 2,000 participants enrollment target places it among the larger protocols in the corpus, above the 75-participant average among 6 other Apnea of Prematurity trials with a reported enrollment target (2567% higher).
The record links to 1 condition, with Apnea of Prematurity appearing as the primary indexed condition, and to 1 intervention - of which Caffeine citrate injection is the first listed.
NCT00182312 names 20 study sites across 12 states, led by Ontario, Victoria, British Columbia.
Frequently Asked Questions
What is clinical trial NCT00182312 about?
NCT00182312 is a clinical study titled "Caffeine for Apnea of Prematurity (CAP)". At least 5 of every 1000 live-born babies are very premature and weigh only 500 to 1250 grams at birth. Approximately 30-40% of these high-risk infants either die or survive with lasting disabilities. The aim of this research is to reduce this heavy burden of illness. A multi-center randomized contr...
What is the current status of trial NCT00182312?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,000 participants. The study started on 1999-10. Estimated completion is 2016-07.
What conditions does trial NCT00182312 study?
This clinical trial studies the following conditions: Apnea of Prematurity.
What interventions are being tested in trial NCT00182312?
The interventions under investigation include: Caffeine citrate injection (DRUG).
Who is sponsoring clinical trial NCT00182312?
This trial is sponsored by McMaster University, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00182312 being conducted?
This trial has 20 study locations across New York, Australian Capital Territory, South Australia, Victoria, Alberta. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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