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To guide future practice, perinatal trials should be much larger, simpler and less fragile with close to 100% ascertainment of mortality and other key outcomes.
Tarnow-Mordi, William Odita; Robledo, Kristy; Marschner, Ian; Seidler, Lene; Simes, John.
Afiliação
  • Tarnow-Mordi WO; From the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Australia; Neonatal and Perinatal Trials, NHMRC Clinical Trials Centre, Medical Foundation Building, Medical Levels 4-6, 92-94 Parramatta Rd, Camperdown NSW 2050, Australia. Electronic address: willia
  • Robledo K; From the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Australia.
  • Marschner I; From the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Australia.
  • Seidler L; From the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Australia.
  • Simes J; From the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Australia.
Semin Perinatol ; 47(5): 151789, 2023 08.
Article em En | MEDLINE | ID: mdl-37422415
The Australian Placental Transfusion Study (APTS) randomised 1,634 fetuses to delayed (≥60 s) versus immediate (≤10 s) clamping of the umbilical cord. Systematic reviews with meta-analyses, including this and similar trials, show that delaying clamping in preterm infants reduces mortality and need for blood transfusions. Amongst 1,531 infants in APTS followed up at two years, aiming to delay clamping for 60 s or more reduced the relative risk of the primary composite outcome of death or disability by 17% (p = 0.01). However, this result is fragile because nominal statistical significance (p < 0.05) would be abolished by only 2 patients switching from a non-event to an event, and the primary composite outcome was missing in 112 patients (7%). To achieve more robust evidence, any future trials should emulate the large, simple trials co-ordinated from Oxford which reliably identified moderate, incremental improvements in mortality in tens of thousands of participants, with <1% missing data. Those who fund, regulate, and conduct trials that aim to change practice should repay the trust of those who consent to participate by doing everything possible to minimise missing data for key outcomes.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Placenta / Recém-Nascido Prematuro Tipo de estudo: Clinical_trials / Etiology_studies Limite: Female / Humans / Infant / Newborn / Pregnancy País/Região como assunto: Oceania Idioma: En Revista: Semin Perinatol Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Placenta / Recém-Nascido Prematuro Tipo de estudo: Clinical_trials / Etiology_studies Limite: Female / Humans / Infant / Newborn / Pregnancy País/Região como assunto: Oceania Idioma: En Revista: Semin Perinatol Ano de publicação: 2023 Tipo de documento: Article