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NCT01783561 · ClinicalTrials.gov registry record · Phase 4
Early Versus Routine Caffeine Administration in Extremely Preterm Neonates
A Phase 4 study of Caffeine, sponsored by Sharp HealthCare.
- Completed
- Registry status
- Phase 4
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT01783561: Completed Phase 4 study of Caffeine, sponsored by Sharp HealthCare.
NCT01783561 is a Phase 4 study of Caffeine that has completed, run by Sharp HealthCare. The registered enrollment target is 21 participants, below the 72-participant average among 6 other Caffeine trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01783561, a Phase 4 study of Caffeine, has completed, sponsored by Sharp HealthCare.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
Premature infants are at risk of having pauses in breathing, or apneas, due to their immaturity. Premature infants are routinely given caffeine, a respiratory stimulant, on the first day of life to prevent apneas. However, if they continue to have apneas, they may require a breathing tube to be placed in the trachea. There are risks to having a breathing tube, so it would be beneficial to avoid it if possible. If caffeine is given earlier, it may decrease the need for a breathing tube. Some studies also suggest that caffeine may also improve heart function which may prevent low blood pressure if given early.
Primary Outcome
The primary aim of our study is to compare the respiratory effects of caffeine administered in the first 2 hours versus at 12 hours of life in infants \<29 weeks' gestation. Our primary hypothesis is that early caffeine administered (at \< 2 hours of life) can prevent the need for endotracheal intubation in the first 12 hours of life.
Conditions Studied
Interventions
- DRUG Caffeine
Study Locations (1)
California
- Sharp Memorial Hospital - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2013-10 |
| Est. Completion | 2014-05 |
| Phase | Phase 4 |
What the finished NCT01783561 record still lists
NCT01783561 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 72-participant average among 6 other Caffeine trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Caffeine appearing as the primary indexed condition, and to 1 intervention - of which Caffeine is the first listed.
NCT01783561 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01783561 about?
NCT01783561 is a clinical study titled "Early Versus Routine Caffeine Administration in Extremely Preterm Neonates". Premature infants are at risk of having pauses in breathing, or apneas, due to their immaturity. Premature infants are routinely given caffeine, a respiratory stimulant, on the first day of life to prevent apneas. However, if they continue to have apneas, they may require a breathing tube to be plac...
What is the current status of trial NCT01783561?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 21 participants. The study started on 2013-10. Estimated completion is 2014-05.
What conditions does trial NCT01783561 study?
This clinical trial studies the following conditions: Caffeine.
What interventions are being tested in trial NCT01783561?
The interventions under investigation include: Caffeine (DRUG).
Who is sponsoring clinical trial NCT01783561?
This trial is sponsored by Sharp HealthCare, which has 32 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01783561 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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