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 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.