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NCT03321734 · ClinicalTrials.gov registry record · Phase 2
Intermittent Hypoxia and Caffeine in Infants Born Preterm
A Phase 2 study, sponsored by Children's National Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 170
- Enrollment target
NCT03321734 is a Phase 2 study that has completed, run by Children's National Research Institute. The registered enrollment target is 170 participants.
The verdict
NCT03321734, a Phase 2 study, has completed, sponsored by Children's National Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 170 participants
- Enrollment target
Study Summary
Intermittent Hypoxia and Caffeine in Infants Born Preterm (ICAF) Our proposal will address the critical question: is persisting intermittent hypoxia (IH) in preterm infants associated with biochemical, structural, or functional injury, and is this injury attenuated with extended caffeine treatment? The investigators will study the effects of caffeine on IH in 220 preterm infants born at ≤30 weeks + 6 days gestation. Infants who are currently being treated with routine caffeine, and who meet eligibility criteria, will be enrolled between 32 weeks + 0 days and 36 weeks + 6 days PMA. At enrollment, infants will be started on continuous pulse oximeter recording of O2 saturation and heart rate. If, based on standard clinical criteria, the last dose of routine caffeine is given on or before the day the infant is 36 weeks + 5 days PMA, then on the day following their last dose of routine caffeine treatment, infants will be randomized (110/group) to extended caffeine treatment or placebo. Randomized infants should begin receiving study drug (i.e. 5 mg/kg/of caffeine base, or equal volume of placebo) on the day of randomization, but no later than the third calendar day following the last dose of routine caffeine. Prior to 36 weeks + 0 days PMA, study drug will be given once daily (i.e. 5mg/kg/day) and beginning at 36 weeks + 0 days PMA, study drug will be given twice daily (i.e. 10 mg/kg/day). The last dose of study drug will be given at 42 weeks + 6 days PMA. Pulse oximeter recordings will continue 1 additional week after discontinuing study drug. Two caffeine levels will be obtained, the 1st at one week after beginning study drug, and the 2nd at a target date of 40 weeks + 0 days PMA, but no later than the last day of study drug, whether in hospital or at home. Inflammatory biomarkers will be measured at study enrollment and again at 38 weeks + 0 days PMA, or within 2 calendar days prior to hospital discharge, whichever comes first. Quantitative MRI/MRS should be obtained
Interventions
- DRUG Placebos
- DRUG Caffeine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2019-01-18 |
| Est. Completion | 2023-06-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03321734
The ClinicalTrials.gov registry entry for NCT03321734 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 170 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's National Research Institute, which has 92 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT03321734 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03321734 about?
NCT03321734 is a clinical study titled "Intermittent Hypoxia and Caffeine in Infants Born Preterm". Intermittent Hypoxia and Caffeine in Infants Born Preterm (ICAF) Our proposal will address the critical question: is persisting intermittent hypoxia (IH) in preterm infants associated with biochemical, structural, or functional injury, and is this injury attenuated with extended caffeine treatment? ...
What is the current status of trial NCT03321734?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 170 participants. The study started on 2019-01-18. Estimated completion is 2023-06-01.
What interventions are being tested in trial NCT03321734?
The interventions under investigation include: Placebos (DRUG), Caffeine (DRUG).
Who is sponsoring clinical trial NCT03321734?
This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.
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