Study protocol safety and efficacy of propranolol in newborns with Retinopathy of Prematurity (PROP-ROP) ISRCTN18523491 英文参考文献.docVIP

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Study protocol safety and efficacy of propranolol in newborns with Retinopathy of Prematurity (PROP-ROP) ISRCTN18523491 英文参考文献.doc

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Study protocol safety and efficacy of propranolol in newborns with Retinopathy of Prematurity (PROP-ROP) ISRCTN18523491 英文参考文献

Filippietal.BMCPediatrics2010,10:83 /1471-2431/10/83 STUDY PROTOCOL OpenAccess Studyprotocol:safetyandefficacyofpropranolol innewbornswithRetinopathyofPrematurity (PROP-ROP):ISRCTLucaFilippi1*,GiacomoCavallaro2,PatrizioFiorini1,MartaDaniotti1,ValentinaBenedetti2,GloriaCristofori2, GabriellaAraimo2,LucaRamenghi2,AgostinoLaTorre3,PinaFortunato4,LilianaPollazzi3,GiancarlolaMarca5, SabrinaMalvagia5,PaolaBagnoli6,ChiaraRistori6,MassimoDalMonte6,AnnaRitaBilia7,BenedettaIsacchi7, SandraFurlanetto7,FrancescaTinelli8,GiovanniCioni8,9,GianpaoloDonzelli10,SilviaOsnaghi11,FabioMosca2 Abstract Background:Despitenewtherapeuticapproacheshaveimprovedtheprognosisofnewbornswithretinopathyof prematurity(ROP),anunfavourablestructuralandfunctionaloutcomestillremainshigh.Thereishighpressureto developnewdrugstopreventandtreatROP.Thereisincreasingenthusiasmforanti-VEGFdrugs,butangiogenic inhibitorsselectiveforabnormalbloodvesselswouldbeconsideredasanoptimaltreatment. Inananimalexperimentalmodelofproliferativeretinopathy,wehaverecentlydemonstratedthatthepharmacological blockadeofbeta-adrenoreceptorsimprovesretinalneovascularizationandbloodretinalbarrierbreakdownconsequent tohypoxia.Thepurposeofthisstudyistoevaluatethepropranololadministrationinpretermnewbornssufferingfrom aprecociousphaseofROPintermsofsafetyandefficacyincounteractingtheprogressionofretinopathy. Methods/Design:Pretermnewborns(gestationalageatbirthlowerthan32weeks)withstage2ROP(zoneII-III withoutplus)willberandomized,accordingtotheirgestationalage,toreceivepropranololaddedtostandard treatment(treatmentadoptedbytheETROPCooperativeGroup)orstandardtreatmentalone.Propranololwillbe administereduntilretinalvascularizationwillbecompletelydeveloped,butnotmorethan90days.Forty-four participantswillberecruitedintothestudy.Toevaluatethesafetyofpropranololadministration,cardiacand respiratoryparameterswillbecontinuouslymonitored.Bloodsamplingswillbeperformedtocheckrenal,liverand metabolicbalance.Toevaluatetheefficacyofproprano