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Generated: September 17, 2019

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CLINICAL TRIALS PROFILE FOR CAFFEINE CITRATE

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Clinical Trials for Caffeine Citrate

Trial ID Title Status Sponsor Phase Summary
NCT00809055 MRI and Neurodevelopment in Preterm Infants Following Administration of High-Dose Caffeine Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 4 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.
NCT00809055 MRI and Neurodevelopment in Preterm Infants Following Administration of High-Dose Caffeine Completed Washington University School of Medicine Phase 4 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.
NCT01408173 Clinical Study of Caffeine for Apnea of Prematurity Completed Nobelpharma Phase 3 The aim of the present Phase III study is to evaluate the safety, efficacy and pharmacokinetics of Caffeine Citrate for treatment of apnea of prematurity in Japan.
NCT01435486 Caffeine Citrate for the Treatment of Apnea Associated With Bronchiolitis in Young Infants Completed Hamad Medical Corporation N/A Viral bronchiolitis is the most common lower respiratory tract infection of infancy. Apnea is a complication of bronchiolitis, reported in 16 - 21% of cases. Caffeine, a trimethylxanthine, acts as an antagonist to endogenous adenosine and a potent central nervous system stimulant. In apnea of prematurity, caffeine is believed to work by increasing central respiratory drive. Infants ≤4 months of age, presenting to pediatric emergency center Al-Sadd, from September 2011 to May 2014, with a diagnosis of viral bronchiolitis associated with apnea. A randomized, double-blind, controlled trial with a sample size of 45 patients per group Data Collection methods, instruments used measurements: Randomization: In the emergency department, the patients will be assigned to either one of the two treatments using a computer-generated randomized numbers in a 1:1 ratio. Pharmacy will prepare sequential sealed vials containing the experimental drugs. Randomization code will be revealed only after all patients completed the study. The medical team in addition to the patients will be blinded to the medication delivered. There will be no detectable difference in the color, smell of the two study treatments. Guardians or parents of eligible infants will be approached regarding the study, explaining the purpose and the treatment modalities. Patients will be included after obtaining a verbal and written consent. Study Intervention: Treatment 1: Single stat dose (25 mg per kilogram of body weight) of intravenous caffeine citrate (25mg caffeine citrate equal to 12.5mg caffeine base). Treatment 2: Placebo with an equivalent volume of normal saline. Calculated study medications will be diluted with Dextrose 5% in Water to 20 ml and will be given intravenous over 30 minutes using syringe infusion pump. After random assignment, eligible infants will receive one of the study treatments. Non-pharmacological therapies may be used as necessary to control apnea. Antibiotics and antipyretics may be used as per the discretion of the treating physician. After stabilization of patients as usually done in Pediatric Emergency Center , patients will be admitted to pediatric intensive care unit (PICU) for further monitoring monitoring when indicated.
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Clinical Trial Conditions for Caffeine Citrate

Condition Name

Condition Name for Caffeine Citrate
Intervention Trials
Apnea of Prematurity 5
Apnea 3
Caffeine 3
Intermittent Hypoxia 1
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Condition MeSH

Condition MeSH for Caffeine Citrate
Intervention Trials
Premature Birth 4
Apnea 4
Liver Diseases 1
Cerebral Hemorrhage 1
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Clinical Trial Locations for Caffeine Citrate

Trials by Country

Trials by Country for Caffeine Citrate
Location Trials
United States 24
Japan 3
Egypt 2
United Kingdom 1
Israel 1
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Trials by US State

Trials by US State for Caffeine Citrate
Location Trials
California 3
New York 2
North Carolina 2
Maryland 2
Pennsylvania 2
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Clinical Trial Progress for Caffeine Citrate

Clinical Trial Phase

Clinical Trial Phase for Caffeine Citrate
Clinical Trial Phase Trials
Phase 4 4
Phase 3 5
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Caffeine Citrate
Clinical Trial Phase Trials
Completed 7
Not yet recruiting 5
Recruiting 5
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Clinical Trial Sponsors for Caffeine Citrate

Sponsor Name

Sponsor Name for Caffeine Citrate
Sponsor Trials
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 4
American SIDS Institute 2
University of Massachusetts, Worcester 1
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Sponsor Type

Sponsor Type for Caffeine Citrate
Sponsor Trials
Other 25
NIH 6
U.S. Fed 2
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