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Caffeine to Reduce Mechanical Ventilation in Preterm Infants

This study has been terminated.
(Safety)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01751724
First Posted: December 18, 2012
Last Update Posted: June 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eduardo Bancalari, University of Miami
December 12, 2012
December 18, 2012
February 28, 2017
June 19, 2017
June 19, 2017
December 2012
January 2016   (Final data collection date for primary outcome measure)
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.
Time to first elective extubation [ Time Frame: From the time of first intubation until the first elective extubation, up to 36 weeks corrected age ]
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 ]
  • Total Duration of Mechanical Ventilation [ Time Frame: From the time of first intubation until the last extubation, up to 36 weeks corrected age ]
  • 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 ]
  • Number of Infants With Bronchopulmonary Dysplasia (BPD) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From the time of randomization up to 36 weeks corrected age, or until the time of discharge or death ]
  • Total Duration of Mechanical Ventilation [ Time Frame: From the time of first intubation until the last extubation, up to 36 weeks corrected age ]
  • 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 ]
  • Bronchopulmonary dysplasia (BPD) [ Time Frame: Evaluated at 36 weeks corrected postmenstrual age ]
    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 ]
  • Number of Infants With Pulmonary Hemorrhage [ Time Frame: From enrollment until 36 weeks postmenstrual age, discharge or death ]
  • Number of Infants With Necrotizing Enterocolitis [ Time Frame: From enrollment until 36 weeks postmenstrual age, discharge or death ]
  • Number of Infants With Septicemia [ Time Frame: From enrollment until 36 weeks postmenstrual age, discharge or death ]
    Septicemia defined as positive blood culture
  • Number of Infants With Severe Intraventricular Hemorrhage [ Time Frame: From enrollment until 36 weeks postmenstrual age, discharge or death ]
    Severe intraventricular hemorrhage defined as grade III or higher
  • Number of Infants With Severe Retinopathy of Prematurity [ Time Frame: From enrollment until 36 weeks postmenstrual age, discharge or death ]
    Severe retinopathy of prematurity defined as stage 3 or higher
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
 
Terminated
87
January 2016
January 2016   (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
Sexes Eligible for Study: All
up to 5 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01751724
20120786
Yes
Not Provided
Not Provided
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 2017

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