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A Pilot Randomized Controlled Trial of Early Targeted Patent Ductus Arteriosus Treatment Using a Risk Based Severity Score (The PDA RCT).
El-Khuffash, Afif; Bussmann, Neidín; Breatnach, Colm R; Smith, Aisling; Tully, Elizabeth; Griffin, Joanna; McCallion, Naomi; Corcoran, John David; Fernandez, Elena; Looi, Claudia; Cleary, Brian; Franklin, Orla; McNamara, Patrick J.
Afiliação
  • El-Khuffash A; Department of Neonatology, The Rotunda Hospital, Dublin, Ireland; Department of Pediatrics, The Royal College of Surgeons in Ireland, Dublin, Ireland. Electronic address: afifelkhuffash@rcsi.com.
  • Bussmann N; Department of Neonatology, The Rotunda Hospital, Dublin, Ireland.
  • Breatnach CR; Department of Neonatology, The Rotunda Hospital, Dublin, Ireland.
  • Smith A; Department of Neonatology, The Rotunda Hospital, Dublin, Ireland.
  • Tully E; Department of Obstetrics & Gynecology, The Royal College of Surgeons in Ireland, Dublin, Ireland.
  • Griffin J; Department of Research & Academic Affairs, The Rotunda Hospital, Dublin, Ireland.
  • McCallion N; Department of Neonatology, The Rotunda Hospital, Dublin, Ireland; Department of Pediatrics, The Royal College of Surgeons in Ireland, Dublin, Ireland.
  • Corcoran JD; Department of Neonatology, The Rotunda Hospital, Dublin, Ireland; Department of Pediatrics, The Royal College of Surgeons in Ireland, Dublin, Ireland.
  • Fernandez E; Department of Pharmacy, The Rotunda Hospital, Dublin, Ireland.
  • Looi C; Department of Pharmacy, The Rotunda Hospital, Dublin, Ireland.
  • Cleary B; Department of Pharmacy, The Rotunda Hospital, Dublin, Ireland; School of Pharmacy, Royal College of Surgeons in Ireland, Dublin, Ireland.
  • Franklin O; Department of Pediatric Cardiology, Our Lady's Children's Hospital Crumlin, Ireland.
  • McNamara PJ; Division of Neonatology, Stead Family Children's Hospital, Iowa City, IA; Department of Pediatrics, University of Iowa, Iowa City, IA; Department of Cardiology, University of Iowa, Iowa City, IA.
J Pediatr ; 229: 127-133, 2021 02.
Article em En | MEDLINE | ID: mdl-33069668
OBJECTIVES: To evaluate the feasibility of recruiting preterm infants to a randomized controlled trial of patent ductus arteriosus (PDA) treatment based on a PDA severity score (PDAsc) and to characterize challenges in obtaining consent, compliance with the protocol, and PDA closure rates. STUDY DESIGN: This single-center, randomized control pilot study of 60 infants <29 weeks of gestation with a high PDAsc (≥5.0) at 36-48 hours of age receiving either ibuprofen or placebo intravenously. The study protocol did not allow for additional PDA therapy within the first 2 weeks. We reported the rate of consent, open label treatment, and PDA closure rates. The primary outcome was chronic lung disease or death. RESULTS: We approached 83 families for enrollment with 73 (88%) providing consent; 13 infants had a PDAsc of <5; of the remaining infants, 30 were assigned ibuprofen and 30 received placebo. Eight infants received open label treatment in the first 2 weeks (12%). The overall PDA closure rate after treatment was 57% in the intervention group and 17% in the control group (P < .01). There was no difference in the primary clinical outcome (OR, 0.8; 95% CI, 0.3-2.1). CONCLUSIONS: Using a PDAsc for infant recruitment to a PDA treatment randomized controlled trial is feasible. There is a high rate of consent and relatively low rate of open-label PDA treatment. The overall PDA closure rate in the intervention arm was low placing the emphasis on devising more effective PDA closure strategies in future randomized controlled trials. TRIAL REGISTRATION: ISRCTN (13281214) and European Union Drug Regulating Authorities Clinical Trials Database (2015-004526-33).
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Índice de Gravidade de Doença / Medição de Risco / Permeabilidade do Canal Arterial / Doenças do Prematuro Tipo de estudo: Clinical_trials / Etiology_studies / Guideline / Risk_factors_studies Limite: Female / Humans / Male / Newborn Idioma: En Revista: J Pediatr Ano de publicação: 2021 Tipo de documento: Article País de publicação: Estados Unidos
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Índice de Gravidade de Doença / Medição de Risco / Permeabilidade do Canal Arterial / Doenças do Prematuro Tipo de estudo: Clinical_trials / Etiology_studies / Guideline / Risk_factors_studies Limite: Female / Humans / Male / Newborn Idioma: En Revista: J Pediatr Ano de publicação: 2021 Tipo de documento: Article País de publicação: Estados Unidos