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Generated: December 17, 2018

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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.
NCT01751724 Caffeine to Reduce Mechanical Ventilation in Preterm Infants Terminated University of Miami N/A 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.
NCT01783561 Early Versus Routine Caffeine Administration in Extremely Preterm Neonates Completed Sharp HealthCare Phase 4 Premature infants are at risk of having pauses in breathing, or apneas, due to their immaturity. Premature infants are routinely given caffeine, a respiratory stimulant, on the first day of life to prevent apneas. However, if they continue to have apneas, they may require a breathing tube to be placed in the trachea. There are risks to having a breathing tube, so it would be beneficial to avoid it if possible. If caffeine is given earlier, it may decrease the need for a breathing tube. Some studies also suggest that caffeine may also improve heart function which may prevent low blood pressure if given early.
Trial ID Title Status Sponsor Phase Summary

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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
Liver Disease 1
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Condition MeSH

Condition MeSH for Caffeine Citrate
Intervention Trials
Apnea 4
Premature Birth 3
Cerebral Hemorrhage 1
Anoxia 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
United Kingdom 1
Israel 1
Qatar 1
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Trials by US State

Trials by US State for Caffeine Citrate
Location Trials
California 3
North Carolina 2
Maryland 2
Pennsylvania 2
New York 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 4
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Caffeine Citrate
Clinical Trial Phase Trials
Completed 6
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
Washington University School of Medicine 1
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Sponsor Type

Sponsor Type for Caffeine Citrate
Sponsor Trials
Other 24
NIH 6
U.S. Fed 2
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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Daiichi Sankyo
Fish and Richardson
US Department of Justice
Express Scripts
Teva
Boehringer Ingelheim
Farmers Insurance
Chinese Patent Office

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