Lack of Equipoise in the PDA-TOLERATE Trial: A Comparison of Eligible Infants Enrolled in the Trial and Those Treated Outside the Trial.
J Pediatr
; 213: 222-226.e2, 2019 10.
Article
em En
| MEDLINE
| ID: mdl-31255386
ABSTRACT
The PDA TO LEave it alone or Respond And Treat Early trial compared the effects of 2 strategies for treatment of patent ductus arteriosus (PDA) in infants <280/7 weeks of gestation; however 137 potentially eligible infants were not recruited and received treatment of their PDA outside the PDA-TOLERATE trial due to "lack-of-physician-equipoise" (LPE). Despite being less mature and needing more respiratory support, infants with LPE had lower rates of mortality than enrolled infants. Infants with LPE treated before day 6 had lower rates of late respiratory morbidity than infants with LPE treated ≥day 6. TRIAL REGISTRATION ClinicalTrials.gov NCT01958320.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Projetos de Pesquisa
/
Esquema de Medicação
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Ensaios Clínicos Controlados Aleatórios como Assunto
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Seleção de Pacientes
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Permeabilidade do Canal Arterial
Tipo de estudo:
Clinical_trials
/
Etiology_studies
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Observational_studies
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Risk_factors_studies
Limite:
Female
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Humans
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Male
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Newborn
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article