Caffeine to Reduce Mechanical Ventilation in Preterm Infants

University of Miami

Status: Terminated

Conditions: Prematurity; Respiratory Failure; Apnea

Treatments: Drug: Caffeine citrate; Other: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01751724

20120786

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 1 to 5 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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87 participants in 2 patient groups, including a placebo group

Caffeine Arm

Experimental group

Description:

Subjects randomized to this arm will receive blinded Caffeine citrate.

Treatment:

Drug: Caffeine citrate

Placebo Arm

Placebo Comparator group

Description:

Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).

Treatment:

Other: Normal saline