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NCT02524249 · ClinicalTrials.gov registry record · NA
Early Versus Late Caffeine for ELBW Newborns
A NA study, sponsored by Wayne State University.
- Terminated
- Registry status
- NA
- Development phase
- 110
- Enrollment target
NCT02524249 is a NA study that was terminated before completion, run by Wayne State University. The registered enrollment target is 110 participants.
The verdict
NCT02524249, a NA study, was terminated before completion, sponsored by Wayne State University.
- TERMINATED
- Registry status
- NA
- Development phase
- 110 participants
- Enrollment target
Study Summary
Caffeine is routinely used in the management of apnea of prematurity. Extremely low birth weight (ELBW) infants are at higher risk of mortality and various neonatal morbidities such as bronchopulmonary dysplasia (BPD) for which caffeine has been shown to be beneficial in very low birth weight (VLBW) infants. The investigators' previous unpublished retrospective studies and recently published retrospective studies demonstrated that early caffeine given within 48 hours of age tended to decrease the incidence of death and BPD in ELBW newborns. Retrospective design can be biased as newborns with mild lung disease may have received caffeine early for extubation. There are several studies on pharmacodynamics and pharmacokinetics of caffeine. The data regarding cumulative dosage of caffeine, caffeine levels and BPD outcome is deficient. Primary objective of this study is to test the hypothesis that early caffeine given within 24 hours of life will decrease incidence of mortality and BPD in ventilated ELBW newborns. This study will also test an additional hypothesis that higher caffeine dosage and caffeine levels are associated with decreased mortality and postnatal morbidities in studied newborns.
Interventions
- DRUG Caffeine
- DRUG Placebo (dextrose)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2015-09 |
| Est. Completion | 2019-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02524249
The ClinicalTrials.gov registry entry for NCT02524249 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wayne State University, which has 163 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Caffeine is the first listed.
NCT02524249 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02524249 about?
NCT02524249 is a clinical study titled "Early Versus Late Caffeine for ELBW Newborns". Caffeine is routinely used in the management of apnea of prematurity. Extremely low birth weight (ELBW) infants are at higher risk of mortality and various neonatal morbidities such as bronchopulmonary dysplasia (BPD) for which caffeine has been shown to be beneficial in very low birth weight (VLBW)...
What is the current status of trial NCT02524249?
This trial is currently terminated. It is a NA study. The enrollment target is 110 participants. The study started on 2015-09. Estimated completion is 2019-06.
What interventions are being tested in trial NCT02524249?
The interventions under investigation include: Caffeine (DRUG), Placebo (dextrose) (DRUG).
Who is sponsoring clinical trial NCT02524249?
This trial is sponsored by Wayne State University, which has 163 total clinical trials registered on ClinicalTrials.gov.
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