Caffeine to Reduce Mechanical Ventilation in Preterm Infants

Not Applicable

Terminated

Conditions: Respiratory Failure
Prematurity
Apnea

Interventions: Drug: Caffeine citrate
Other: Normal saline

Registration Number: NCT01751724

Lead Sponsor: University of Miami

Brief 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.

Methods:

Infants will be randomized within the first 5 days to receive a study drug consisting of either blinded Caffeine citrate or blinded Placebo (equivalent volume of normal saline). Infants will continue to receive the study drug until the first elective extubation.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 87

Inclusion Criteria

Premature neonates born between 23 and 30 completed weeks of gestation.
Requiring mechanical ventilation within the first 5 postnatal days
Written-informed parental consent for the study

Exclusion Criteria

Major congenital anomalies
Small for gestational age

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caffeine Arm	Caffeine citrate	Subjects randomized to this arm will receive blinded Caffeine citrate.
Placebo Arm	Normal saline	Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).

Primary Outcome Measures

Name	Time	Method
Age at First Successful Extubation	From birth to until 36 weeks postmenstrual age	Defined as age of extubation with infant remaining extubated for more than 24 hours.

Secondary Outcome Measures

Name	Time	Method
Total Duration of Mechanical Ventilation	From the time of first intubation until the last extubation, up to 36 weeks corrected age
Total Duration of Oxygen Supplementation	From the time of first initiation until the last day of oxygen supplementation, up to 36 weeks corrected age
Number of Infants With Bronchopulmonary Dysplasia (BPD)	Evaluated at 36 weeks corrected postmenstrual age	BPD defined as need for oxygen for at least 28 days and at 36 weeks post-menstrual age.
Survival Without BPD	From the time of randomization until 36 weeks corrected age, discharge or death	Discharge alive without BPD. BPD defined as need for oxygen for at least 28 days and at 36 weeks post-menstrual age.
Survival	From the time of randomization up to 36 weeks corrected age, or until the time of discharge or death