NCT01751724

Use of Caffeine to Reduce Length of Mechanical Ventilation in Preterm Infants

Terminated NA Results posted Last updated 17 May 2017

What this trial tests

NA trial testing Caffeine citrate in Prematurity in 87 participants. Terminated before completion.

Timeline

1 December 2012

Primary endpoint
1 January 2016

1 January 2016

Quick facts

Lead sponsor	University of Miami
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	87
Start date	1 December 2012
Primary completion	1 January 2016
Estimated completion	1 January 2016
Sites	1 location across United States

Drugs / interventions tested

• Caffeine citrate — full drug profile →
• Normal saline

Conditions studied

• Prematurity — all drugs for Prematurity →
• Apnea — all drugs for Apnea →
• Respiratory Failure — all drugs for Respiratory Failure →

Sponsor

University of Miami

Who can join

Adults 1 Day to 5 Days, any sex, with Prematurity or Apnea. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Caffeine therapy in preterm infants.
   Abdel-Hady H, Nasef N, Shabaan AE, Nour I. · · 2015 · cited 108× · PMID 26566480 · DOI 10.5409/wjcp.v4.i4.81
2. Early Caffeine and Weaning from Mechanical Ventilation in Preterm Infants: A Randomized, Placebo-Controlled Trial.
   Amaro CM, Bello JA, Jain D, Ramnath A, et al · · 2018 · cited 47× · PMID 29519541 · DOI 10.1016/j.jpeds.2018.01.010