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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00809055
Other study ID # 08-0849
Secondary ID R01HD057098-01HR
Status Completed
Phase Phase 4
First received December 15, 2008
Last updated January 26, 2016
Start date November 2008
Est. completion date December 2015

Study information

Verified date January 2016
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Over the last 30 years the survival rates for babies born prematurely have improved greatly with research. As these babies grow up, we have found that many of the premature babies have learning and movement problems. The purpose of this research is to learn why premature infants are at risk for learning disabilities and movement problems later in childhood and whether this is changed by caffeine therapy. Caffeine is often used in premature babies to help them to breathe on their own. Nearly all babies born before 30 weeks gestation receive caffeine while they are in the neonatal intensive care unit (NICU). Scientists have shown that caffeine therapy given to premature babies reduces their disabilities.

We will use brain monitoring, including electro-encephalogram (EEG) and magnetic resonance imaging (MRI) to understand how the brain of a premature baby develops and whether caffeine in high doses enhances protection of the developing brain. Just as we monitor the heart and lungs to improve our care of premature babies, we wish to monitor the brain so that we can understand how to improve our care for the brain.


Description:

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Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Intervention

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

Locations

Country Name City State
United States St. Louis Children's Hospital St. Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Washington University School of Medicine Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary White Matter Microstructural Maturation Apparent diffusion coefficient is a measure of microstructural maturation obtained from brain MRI. Participants were followed for the duration of hospital stay, an average of 12 weeks No
Secondary Mortality Rates Participants were followed for the duration of hospital stay, an average of 12 weeks Yes
Secondary Cerebellar Hemorrhage Participants were followed for the duration of hospital stay, an average of 12 weeks No
Secondary Length of Time Requiring Invasive Respiratory Support Participants were followed for the duration of hospital stay, an average of 12 weeks No
Secondary Rates of Chronic Lung Disease Defined as oxygen requirement at 36 weeks PMA Participants were followed for the duration of hospital stay, an average of 12 weeks No
Secondary Rates of Necrotizing Enterocolitis Participants were followed for the duration of hospital stay, an average of 12 weeks Yes
Secondary Rates of Retinopathy of Prematurity Participants were followed for the duration of hospital stay, an average of 12 weeks No
Secondary Evaluation of EEG Seizure Burden For the first 72 hours of life, infants were monitored for seizures using continuous limited channel aEEG. Seizures were defined as a series of sharp waves, at least ten seconds in duration, which evolve in frequency, amplitude, and morphology over time and are clearly distinguishable from the background or artifact. First 72 hours of life Yes
Secondary Infant Neurobehavioral Scoring by Dubowitz Scale Prior to Discharge The Dubowitz Neurologic Examination is a standardized neurologic examination for infants at term age. It includes 6 compound optimality scores summed to obtain the total optimality score. Compound optimality scores include tone (range 0-10), tone pattern (range 0-5), reflexes (range 0-6), movements (range 0-3), abnormal signs (range 0-3), and behavior (range 0-7). The range for the compound optimality score is 0 - 34, with scores between 30.5 and 34 considered optimal and scores below 30.5 considered suboptimal. Participants were followed for the duration of hospital stay, an average of 12 weeks No
Secondary Bayley Scales of Infant Development Cognitive Score at 2 Years of Age The cognitive portion of the Bayley Scales of Infant Development assesses development in infants and toddlers between the ages of 0 and 3 years. Raw scores are converted to scale scores. A scale score of 100 is designed to represent the population mean. Scores below 100 represent developmental delay relative to the mean and scores above 100 represent advanced development relative to the mean. 2 years No
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