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MRI and Neurodevelopment in Preterm Infants Following Administration of High-Dose Caffeine

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00809055
First received: December 15, 2008
Last updated: January 26, 2016
Last verified: January 2016
Results First Received: December 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Apnea of Prematurity
Intraventricular Hemorrhage
Brain Injury
Intervention: Drug: Caffeine citrate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
High Dose Caffeine

Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.

Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages.

Standard Dose Caffeine

Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.

Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages.


Participant Flow:   Overall Study
    High Dose Caffeine   Standard Dose Caffeine
STARTED   37   37 
COMPLETED   28   30 
NOT COMPLETED   9   7 



  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.
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Reporting Groups
  Description
High Dose Caffeine

Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.

Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages.

Standard Dose Caffeine

Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.

Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages.

Total Total of all reporting groups

Baseline Measures
   High Dose Caffeine   Standard Dose Caffeine   Total 
Overall Participants Analyzed 
[Units: Participants]
 37   37   74 
Age [1] 
[Units: Weeks]
Mean (Standard Deviation)
 26.3  (1.9)   26.8  (1.8)   26.7  (1.8) 
[1] Reported as weeks of gestational age at birth
Gender 
[Units: Participants]
     
Female   18   13   31 
Male   19   24   43 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   2   2   4 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   18   23   41 
White   17   12   29 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   37   37   74 


  Outcome Measures
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1.  Primary:   White Matter Microstructural Maturation   [ Time Frame: Participants were followed for the duration of hospital stay, an average of 12 weeks ]

2.  Secondary:   Mortality Rates   [ Time Frame: Participants were followed for the duration of hospital stay, an average of 12 weeks ]

3.  Secondary:   Cerebellar Hemorrhage   [ Time Frame: Participants were followed for the duration of hospital stay, an average of 12 weeks ]

4.  Secondary:   Length of Time Requiring Invasive Respiratory Support   [ Time Frame: Participants were followed for the duration of hospital stay, an average of 12 weeks ]

5.  Secondary:   Rates of Chronic Lung Disease   [ Time Frame: Participants were followed for the duration of hospital stay, an average of 12 weeks ]

6.  Secondary:   Rates of Necrotizing Enterocolitis   [ Time Frame: Participants were followed for the duration of hospital stay, an average of 12 weeks ]

7.  Secondary:   Rates of Retinopathy of Prematurity   [ Time Frame: Participants were followed for the duration of hospital stay, an average of 12 weeks ]

8.  Secondary:   Evaluation of EEG Seizure Burden   [ Time Frame: First 72 hours of life ]

9.  Secondary:   Infant Neurobehavioral Scoring by Dubowitz Scale Prior to Discharge   [ Time Frame: Participants were followed for the duration of hospital stay, an average of 12 weeks ]

10.  Secondary:   Bayley Scales of Infant Development Cognitive Score at 2 Years of Age   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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: Dr. Terrie Inder
Organization: Brigham and Women's Hospital
phone: 617-525-6650
e-mail: tinder@partners.org



Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00809055     History of Changes
Other Study ID Numbers: 08-0849
R01HD057098-01 ( US NIH Grant/Contract Award Number )
HRPO 08-0849 ( Other Identifier: Washington University in St. Louis )
Study First Received: December 15, 2008
Results First Received: December 17, 2015
Last Updated: January 26, 2016
Health Authority: United States: Institutional Review Board