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Caffeine to Reduce Mechanical Ventilation in Preterm Infants

This study has been terminated.
(Safety)
Sponsor:
Information provided by (Responsible Party):
Eduardo Bancalari, University of Miami
ClinicalTrials.gov Identifier:
NCT01751724
First received: December 12, 2012
Last updated: May 17, 2017
Last verified: May 2017
Results First Received: February 28, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Prematurity
Apnea
Respiratory Failure
Interventions: Drug: Caffeine citrate
Other: Normal saline

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was conducted at the Holtz Children's Hospital newborn intensive care unit of Jackson Health System/University of Miami Medical Center from January 2013 to October 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
87 infants were enrolled. Of these, 1 died before randomization. 86 infants were randomized and assigned an intervention arm.

Reporting Groups
  Description
Caffeine Arm

Subjects randomized to this arm will receive blinded Caffeine citrate.

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.

Placebo Arm

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

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.


Participant Flow:   Overall Study
    Caffeine Arm   Placebo Arm
STARTED   42   44 
COMPLETED   41   42 
NOT COMPLETED   1   2 
extubated bef.start assigned treatment                1                0 
withdrawn by parent                0                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Caffeine Arm

Subjects randomized to this arm will receive blinded Caffeine citrate.

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.

Placebo Arm

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

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.

Total Total of all reporting groups

Baseline Measures
   Caffeine Arm   Placebo Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 41   42   83 
Age 
[Units: Hours]
Mean (Standard Deviation)
 48  (25)   49  (31)   48  (28) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      11  26.8%      25  59.5%      36  43.4% 
Male      30  73.2%      17  40.5%      47  56.6% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Black race   19   21   40 
Gestational age 
[Units: Weeks]
Median (Inter-Quartile Range)
 25.7 
 (24.3 to 27.0) 
 26.1 
 (24.2 to 28.4) 
 25.9 
 (24.2 to 27.5) 
Birth weight 
[Units: Grams]
Median (Inter-Quartile Range)
 670 
 (605 to 915) 
 720 
 (643 to 894) 
 700 
 (615 to 906) 
Fraction of inspired oxygen at enrollment 
[Units: Oxygen fraction]
Median (Inter-Quartile Range)
 0.25 
 (0.21 to 0.37) 
 0.23 
 (.21 to .30) 
 .24 
 (.21 to .33) 
Mean airway pressure at enrollment 
[Units: Centimeters of water]
Median (Inter-Quartile Range)
 9 
 (8 to 11) 
 8 
 (8 to 10) 
 9 
 (8 to 10) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Age at First Successful Extubation   [ Time Frame: From birth to until 36 weeks postmenstrual age ]

2.  Secondary:   Survival   [ Time Frame: From the time of randomization up to 36 weeks corrected age, or until the time of discharge or death ]

3.  Secondary:   Total Duration of Mechanical Ventilation   [ Time Frame: From the time of first intubation until the last extubation, up to 36 weeks corrected age ]

4.  Secondary:   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 ]

5.  Secondary:   Number of Infants With Bronchopulmonary Dysplasia (BPD)   [ Time Frame: Evaluated at 36 weeks corrected postmenstrual age ]

6.  Secondary:   Survival Without BPD   [ Time Frame: From the time of randomization until 36 weeks corrected age, discharge or death ]

7.  Other Pre-specified:   Number of Infants With Pulmonary Hemorrhage   [ Time Frame: From enrollment until 36 weeks postmenstrual age, discharge or death ]

8.  Other Pre-specified:   Number of Infants With Necrotizing Enterocolitis   [ Time Frame: From enrollment until 36 weeks postmenstrual age, discharge or death ]

9.  Other Pre-specified:   Number of Infants With Septicemia   [ Time Frame: From enrollment until 36 weeks postmenstrual age, discharge or death ]

10.  Other Pre-specified:   Number of Infants With Severe Intraventricular Hemorrhage   [ Time Frame: From enrollment until 36 weeks postmenstrual age, discharge or death ]

11.  Other Pre-specified:   Number of Infants With Severe Retinopathy of Prematurity   [ Time Frame: From enrollment until 36 weeks postmenstrual age, discharge or death ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Eduardo Bancalari M.D., Director Division of Neonatology
Organization: University of Miami
phone: 3055856408
e-mail: ebancalari@miami.edu



Responsible Party: Eduardo Bancalari, University of Miami
ClinicalTrials.gov Identifier: NCT01751724     History of Changes
Other Study ID Numbers: 20120786
Study First Received: December 12, 2012
Results First Received: February 28, 2017
Last Updated: May 17, 2017