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NCT01751724 · ClinicalTrials.gov registry record · NA
Caffeine to Reduce Mechanical Ventilation in Preterm Infants
A NA study, sponsored by University of Miami.
- Terminated
- Registry status
- NA
- Development phase
- 87
- Enrollment target
NCT01751724 is a NA study that was terminated before completion, run by University of Miami. The registered enrollment target is 87 participants.
The verdict
NCT01751724, a NA study, was terminated before completion, sponsored by University of Miami.
- TERMINATED
- Registry status
- NA
- Development phase
- 87 participants
- Enrollment target
Study Summary
Most premature infants require mechanical ventilation for prolonged periods of time and a significant proportion of them develop Bronchopulmonary Dysplasia (BPD). Caffeine is a stimulant of the respiratory center and has been used for the treatment of Apnea of Prematurity in infants not requiring mechanical ventilation or to facilitate weaning from mechanical ventilation by starting therapy shortly before extubation. Recently the use of Caffeine in ventilated infants has been initiated earlier because of the reported reduction in BPD. However there is paucity of data supporting this practice. Because protracted mechanical ventilation and supplemental oxygen increase the risk of developing BPD, a therapy that would facilitate the reduction of the respiratory support and shorten its duration is desirable. Therefore, it is of importance to evaluate the effects of early Caffeine initiation and administration during the course of mechanical ventilation in preterm infants by means of a randomized placebo-controlled trial. Hypothesis: The primary hypothesis of this study is that early use of caffeine in mechanically ventilated preterm infants will reduce the time to first elective extubation and secondarily, that this will reduce the total duration of mechanical ventilation and oxygen supplementation, and reduce the incidence and severity of BPD. Objective: The objective of this trial is to evaluate the effects of early caffeine use during mechanical ventilation on the time to first elective extubation, total duration of mechanical ventilation and oxygen supplementation, and the incidence of BPD. Study Design: This will be a single-center prospective, randomized, double-blind, placebo controlled clinical trial. Population: Premature neonates born between 23 and 30 completed weeks of gestation, who require mechanical ventilation within the first 5 days of life will be enrolled. Infants with major congenital anomalies or small for gestational age will be excluded.
Interventions
- DRUG Caffeine citrate
- OTHER Normal saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2012-12 |
| Est. Completion | 2016-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01751724
The ClinicalTrials.gov registry entry for NCT01751724 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 87 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Caffeine citrate is the first listed.
NCT01751724 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01751724 about?
NCT01751724 is a clinical study titled "Caffeine to Reduce Mechanical Ventilation in Preterm Infants". Most premature infants require mechanical ventilation for prolonged periods of time and a significant proportion of them develop Bronchopulmonary Dysplasia (BPD). Caffeine is a stimulant of the respiratory center and has been used for the treatment of Apnea of Prematurity in infants not requiring me...
What is the current status of trial NCT01751724?
This trial is currently terminated. It is a NA study. The enrollment target is 87 participants. The study started on 2012-12. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01751724?
The interventions under investigation include: Caffeine citrate (DRUG), Normal saline (OTHER).
Who is sponsoring clinical trial NCT01751724?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
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