Apnea of Prematurity
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2015-10-15Clinical Trial Update: Effects of Non-Nutritive Sucking on Gastroesophageal Reflux and Related Apneas in Symptomatic Preterm Infants
A completed clinical trial evaluating whether non-nutritive sucking affects gastroesophageal reflux and related apneas in symptomatic preter…
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FDA approval · 2015-09-22FDA Approved: CAFFEINE CITRATE — Original Application (Eugia US LLC)
FDA approved caffeine citrate from Eugia US LLC under its original application (ANDA205013), making caffeine citrate available as an approve…
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CLINICAL_TRIALS trial_result · 2015-09-10Clinical Trial Update: Stochastic Resonance Mattress (Physiological Interventions) and Biomarkers for Enhancing Neonatal Health
A completed clinical trial evaluating a stochastic resonance mattress and biomarkers to enhance neonatal health in apnea of prematurity.
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CLINICAL_TRIALS trial_result · 2015-05-08Clinical Trial Update: The Influences of Caffeine on Heart Rate Variability of Preterm Infants
This clinical trial update reports on how caffeine administration affects heart rate variability in preterm infants, shedding light on the a…
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CLINICAL_TRIALS trial_result · 2015-03-17Clinical Trial Update: Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm [Phase 3]
Phase 3 trial evaluating the effect of caffeine citrate on intermittent hypoxia in preterm infants; results have been posted after completio…
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CLINICAL_TRIALS trial_result · 2015-02-19Clinical Trial Update: Inhalation of Low Concentration of CO2 in Preterm Infants Not Responding to Caffeine for the Treatment of Apnea [Phase 2, Phase 3]
A Phase 2/3 trial evaluating inhaled carbon dioxide for apnea of prematurity in infants not responding to caffeine has been terminated.
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CLINICAL_TRIALS trial_result · 2015-01-27Clinical Trial Update: Effect of Three-Stair-Position on Improvement of Apnea of Prematurity [NA]
A completed clinical trial from Children's Hospital of Fudan University evaluating whether the three-stair-position intervention improves ap…
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FDA approval · 2014-12-23FDA Approved: CAFFEINE CITRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for caffeine citrate from Hikma Pharmaceuticals USA Inc., resulting in labeling changes to the exist…
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CLINICAL_TRIALS trial_result · 2014-12-05Clinical Trial Update: Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study [Phase 3]
This clinical trial update reports the completion of Phase 3 CAP-S study evaluating caffeine (caffeine citrate) for Apnea of Prematurity.
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CLINICAL_TRIALS trial_result · 2014-04-04Clinical Trial Update: High Versus Low Dose of Caffeine for Apnea of Prematurity [Phase 3]
A Phase 3 trial comparing high versus low doses of caffeine for apnea of prematurity has completed.
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CLINICAL_TRIALS trial_result · 2013-10-30Clinical Trial Update: Clinical Study of Caffeine for Apnea of Prematurity [Phase 3]
A Phase 3 clinical trial evaluating caffeine citrate for apnea of prematurity has completed.
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FDA approval · 2013-02-25FDA Approved: CAFFEINE CITRATE — Supplemental Application (Sagent Pharmaceuticals)
The FDA approved a supplemental application for caffeine citrate submitted by Sagent Pharmaceuticals, confirming labeling/approval for the p…
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FDA approval · 2012-08-29FDA Approved: CAFFEINE CITRATE — Original Application (Sagent Pharmaceuticals)
FDA approved Sagent Pharmaceuticals' caffeine citrate as a generic drug for the treatment of apnea of prematurity under an Original Applicat…
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CLINICAL_TRIALS research · 2012-02-23Clinical Trial Update: Population Pharmacokinetics and Metabolomics of Theophylline in Preterm Infants
This document provides an update on a clinical trial investigating the population pharmacokinetics and metabolomics of theophylline in prete…
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CLINICAL_TRIALS trial_result · 2010-12-22Clinical Trial Update: Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study [Phase 1]
Phase 1 pilot study evaluating nasal high frequency ventilation in preterm infants with respiratory distress conditions; study completed wit…
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FDA approval · 2010-06-11FDA Approved: CAFFEINE CITRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for caffeine citrate from Hikma Pharmaceuticals USA Inc., enabling regulatory clearance for the supp…
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CLINICAL_TRIALS trial_result · 2010-03-03Clinical Trial Update: CO2 Inhalation as a New Treatment Modality for Apnea of Prematurity [Phase 2, Phase 3]
The document reports the completion of Phase 2 and Phase 3 trials evaluating carbon dioxide inhalation as a treatment for apnea of prematuri…
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CLINICAL_TRIALS trial_result · 2009-11-02Clinical Trial Update: A Study on the Effects of Feeding and Feeding Methods on Breathing Pattern in Very Low Birth Weight Preterm Infants
This completed clinical trial evaluated how feeding and feeding methods affect breathing patterns in very low birth weight preterm infants. …
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FDA approval · 2009-09-30FDA Approved: CAFFEINE CITRATE — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical's caffeine citrate Original Application, a generic product for the treatment of apnea of prematurity. This m…
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CLINICAL_TRIALS trial_result · 2009-05-05Clinical Trial Update: A Trial of Infant Flow Biphasic Nasal Continuous Airway Pressure (NCPAP) Versus Infant Flow NCPAP for the Facilitation of Extubation in Infants </= 1250 Grams [Phase 2]
Phase 2 trial comparing Infant Flow Biphasic NCPAP with standard Infant Flow NCPAP to facilitate extubation in very low birth weight infants…
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CLINICAL_TRIALS research · 2008-06-04Clinical Trial Update: Use of Sucrose to Relieve Pain During Eye Exams in Infants [NA]
A terminated clinical trial studied using sucrose to relieve pain during eye exams in infants. The sponsor was Weill Medical College of Corn…
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FDA approval · 2008-01-31FDA Approved: CAFFEINE CITRATE — Original Application (Fresenius Kabi USA, LLC)
FDA approved Fresenius Kabi USA, LLC's caffeine citrate product under an Original Application, adding a new caffeine citrate option to the m…
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CLINICAL_TRIALS trial_result · 2007-08-24Clinical Trial Update: Randomized Trial Investigating Four Nasal CPAP Systems in the Management of Apnea of Prematurity [NA]
The randomized trial evaluating four nasal CPAP systems for apnea of prematurity has been terminated; no results are provided in the update.
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FDA approval · 2007-07-20FDA Approved: CAFFEINE CITRATE — Original Application (Fresenius Kabi USA, LLC)
FDA approved the original application for caffeine citrate (generic) filed by Fresenius Kabi USA, LLC.
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CLINICAL_TRIALS trial_result · 2007-05-02Clinical Trial Update: Randomized Trial of Nasal Continuous Positive Airway Pressure or Synchronized Nasal Ventilation in Premature Infants. [Phase 3]
Phase 3 randomized trial comparing nasal continuous positive airway pressure with synchronized nasal ventilation in premature infants. The s…