Does crossover treatment of control subjects invalidate results of randomized trials of patent ductus arteriosus treatment?
Optimal management of patent ductus arteriosus (PDA) in extremely preterm infants remains controversial. There is paucity of evidence on the benefits of PDA treatment in reducing mortality and morbidities in extremely preterm infants. Failure of randomized clinical trials to demonstrate beneficial e...
| Publicado en: | Journal of Perinatology Vol. 40; no. 12; pp. 1863 - 1871 |
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| Autores principales: | , |
| Formato: | tables/charts Journal Article |
| Publicado: |
Springer Nature
Dec2020
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=147068751&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 147068751 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 07438346 DZF jtl: Journal of Perinatology issn: 07438346 maglogo: Y pubinfo: dt: Dec2020 vid: 40 iid: 12 pid: 2579 pub: Springer Nature place: Dordrecht, <Blank> artinfo: ui: 147068751 147068751 147068751 10.1038/s41372-020-00848-z 147068751 ppf: 1863 ppct: 8 formats: tig: atl: Does crossover treatment of control subjects invalidate results of randomized trials of patent ductus arteriosus treatment? aug: au: Sankar, Meera N. Benitz, William E. affil: Division of Neonatal and Developmental Medicine, Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA, USA sug: subj: Ductus Arteriosus, Patent Therapy Randomized Controlled Trials Research Subjects Treatment Outcomes Morbidity Infant, Premature Infant, Newborn Age Factors Research Subject Recruitment Infant, Newborn: birth-1 month ab: Optimal management of patent ductus arteriosus (PDA) in extremely preterm infants remains controversial. There is paucity of evidence on the benefits of PDA treatment in reducing mortality and morbidities in extremely preterm infants. Failure of randomized clinical trials to demonstrate beneficial effects of PDA treatment on outcomes has often been attributed to open treatment of control subjects. This perspective examines the PDA treatment trials to date, with specific focus on rates of and ages of subjects at open rescue treatment. Although these trials demonstrate that ductal closure is significantly increased with treatment, that does not translate to a significant decrease in major morbidities or mortality in premature infants, even when trials with high rates of rescue treatment of controls are excluded. Trials in which enrollment occurred after 7 days of age include insufficient numbers of subjects to evaluate this relationship. pubtype: Academic Journal doctype: tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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