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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: Clinical Trial NA study, sponsored by University of Miami.
NCT01751724 is a NA study that was terminated before completion, run by University of Miami. The registered enrollment target is 87 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Defined as age of extubation with infant remaining extubated for more than 24 hours.
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 |
Why NCT01751724 stopped before completion
NCT01751724 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Caffeine citrate is the first listed.
NCT01751724 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01751724's enrollment target sits among peer trials
87 974th of 2000 higher than 1,025 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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