Caffeine to Reduce Mechanical Ventilation in Preterm Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Miami
Sponsor:
Information provided by (Responsible Party):
Eduardo Bancalari, University of Miami
ClinicalTrials.gov Identifier:
NCT01751724
First received: December 12, 2012
Last updated: May 7, 2014
Last verified: May 2014

December 12, 2012
May 7, 2014
December 2012
December 2014   (final data collection date for primary outcome measure)
Time to first elective extubation [ Time Frame: From the time of first intubation until the first elective extubation, up to 36 weeks corrected age ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01751724 on ClinicalTrials.gov Archive Site
  • Survival [ Time Frame: From the time of randomization up to 36 weeks corrected age, or until the time of discharge or death ] [ Designated as safety issue: Yes ]
  • Total duration of mechanical ventilation [ Time Frame: From the time of first intubation until the last extubation, up to 36 weeks corrected age ] [ Designated as safety issue: No ]
  • Total duration of oxygen supplementation [ Time Frame: From the time of first initiation until the last day of oxygen supplementation, up to 36 weeks corrected age ] [ Designated as safety issue: No ]
  • Bronchopulmonary dysplasia (BPD) [ Time Frame: Evaluated at 36 weeks corrected postmenstrual age ] [ Designated as safety issue: No ]
    BPD defined as oxygen dependence at 36 weeks post-menstrual age and by physiological test, severe BPD defined as requirement for oxygen FiO2 > 0.3 at 36 weeks post menstrual age or need for positive pressure support.
  • Survival without BPD [ Time Frame: From the time of randomization until 36 weeks corrected age, discharge or death ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Caffeine to Reduce Mechanical Ventilation in Preterm Infants
Use of Caffeine to Reduce Length of 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Prematurity
  • Apnea
  • Respiratory Failure
  • Drug: Caffeine citrate

    Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.

    Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.

    After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.

    Infants will continue to receive the study drug until 12 hours prior to the first elective extubation.

  • Other: Normal saline

    Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).

    Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.

    After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.

    Infants will continue to receive the study drug until 12 hours prior to the first elective extubation.

  • Experimental: Caffeine Arm
    Subjects randomized to this arm will receive blinded Caffeine citrate.
    Intervention: Drug: Caffeine citrate
  • Placebo Comparator: Placebo Arm
    Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).
    Intervention: Other: Normal saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Both
up to 5 Days
No
Contact: Eduardo Bancalari, M.D. 3055856408 ebancalari@miami.edu
Contact: Carmen Dugard, R.R.T. 3055856408 cdugard@med.miami.edu
United States
 
NCT01751724
20120786
Yes
Eduardo Bancalari, University of Miami
University of Miami
Not Provided
Principal Investigator: Eduardo Bancalari, M.D. University of Miami
Principal Investigator: Nelson Claure, M.Sc., Ph.D. University of Miami
University of Miami
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP