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Safety of N-acetylcysteine in Maternal Chorioamnionitis

Safety of N-acetylcysteine in Maternal Chorioamnionitis
N-乙酰半胱氨酸在孕产妇绒毛膜羊膜炎中的安全性
批准号：
7575081
负责人：
DOROTHEA DENISE JENKINS
金额：
$44.16万
依托单位：
MEDICAL UNIVERSITY OF SOUTH CAROLINA
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
项目状态：
已结题
起止时间：
2007-02-27 至 2011-07-31
来源：
https://reporter.nih.gov/project-details/7575081
关键词：
AcetylcysteineAdverse effectsAdverse eventAge-MonthsAnimal ModelAreaBasal GangliaBirthBlood CirculationBlood Flow VelocityBrainBrain InjuriesCerebral PalsyCerebrovascular CirculationCerebrumCholineClinicalClinical TrialsDataDiffusion Magnetic Resonance ImagingDoppler UltrasoundDoseDrug KineticsEncephalitisEnrollmentEvaluationFetusGestational AgeHemorrhageHistamineHomeostasisHourHypotensionHypoxiaIL8 geneIncidenceInfantInfectionInfection of amniotic sac and membranesInflammation MediatorsInflammatoryInjuryInterleukin-6Magnetic Resonance ImagingMeasuresMonitorMorbidity - disease rateMothersMotor CortexNeonatalNeurologicNewborn InfantOutcomePathogenesisPatientsPenetrationPerfusionPeriventricular LeukomalaciaPharmaceutical PreparationsPhase III Clinical TrialsPlacentaPlasmaPopulationPregnancyPregnant WomenPremature InfantProthrombin time assayReactionRecruitment ActivitySafetySample SizeSamplingSerumSpectrum AnalysisTherapeutic InterventionToxic effectTranslational ResearchUmbilical Cord BloodUmbilical cord structurebaseclinical Diagnosiscohortcytokinedesignexperiencefetalgray mattermiddle cerebral arteryneuroprotectionpatient populationpilot trialplacental transferpostnatalpregnantprenatalresponsewhite matterwhite matter injury

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DESCRIPTION (provided by applicant): Intrauterine infection is associated with significant white and grey matter brain injury in newborns and is particularly important in the pathogenesis of periventricular leukomalacia and cerebral palsy. Cytokine release causes far-reaching inflammatory fetal brain injury, which reduces tolerance for hypoxic ischemic injury as well. Very little translational research has been attempted in this area, because protecting the fetal brain through the placenta and the maternal/fetal circulations presents unique challenges. N-acetylcysteine (NAC) is a promising therapy that has shown effective neuroprotection in the animal model of chorioamnionitis, and has a favorable safety profile with known side effects, which appear to be limited and manageable. There is extensive clinical experience with the drug and safety in pregnant mothers and pharmacokinetic data in preterm infants have been established. In this pilot trial we will determine the safety of eifferent dose escalations in the 2 cohorts to adjust for expected differences in clearance and serum concentrations. Measuring maternal PK, as well as infant PK after a maternal loading dose, and estimating placental transfer with paired maternal and cord blood comprise some of the main aims of this trial. Maternal and infant NAC concentrations will then be analyzed for relationship to safety and short term efficacy outcomes to answer the question, what doses or target serum concentrations of NAC have little toxicity and evidence of short term efficacy in preterm and term infants? These studies will generate data which are essential for successful design of a subsequent phase III clinical trial. Neuroprotective therapies which are effective and safe could have a huge impact on neurologic morbidity in this population. As neuroprotective compounds which can be used in this population are quite rare, the evaluation of NAC in this pilot trial will contribute important information for further definitive clinical trials. Therapeutic intervention with NAC in this patient population will be groundbreaking for the next specific aim of fetal neuroprotection.
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