<scp>RCT</scp> evidence should drive clinical practice: A day without randomisation is a day without progress

Tarnow‐Mordi, William; Cruz, Melinda; Morris, Jonathan M.; Mol, Ben Willem J.

doi:10.1111/1471-0528.14468

“…To yield 90% power to detect a 20% difference in the risk of death (8.0% in the immediate-clamping group vs. 6.4% in the delayed-clamping group), a trial would need more than 11,000 patients, probably requiring international collaboration and a greater integration of clinical research with routine care. 33 We found no significant difference in the rates of major morbidity between the randomized groups (Table 3). This finding contrasts with those of earlier systematic reviews involving smaller populations, 1,5 which concluded that delayed clamping reduced intraventricular hemorrhage, 1,5 necrotizing enterocolitis, 1 and late-onset sepsis 1 -evidence that underpins current recommendations for delayed clamping.…”

Section: Discussionmentioning

confidence: 67%

Delayed versus Immediate Cord Clamping in Preterm Infants

Tarnow‐Mordi

¹

,

Morris

²

,

Kirby

³

et al. 2017

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“…To yield 90% power to detect a 20% difference in the risk of death (8.0% in the immediate-clamping group vs. 6.4% in the delayed-clamping group), a trial would need more than 11,000 patients, probably requiring international collaboration and a greater integration of clinical research with routine care. 33 We found no significant difference in the rates of major morbidity between the randomized groups (Table 3). This finding contrasts with those of earlier systematic reviews involving smaller populations, 1,5 which concluded that delayed clamping reduced intraventricular hemorrhage, 1,5 necrotizing enterocolitis, 1 and late-onset sepsis 1 -evidence that underpins current recommendations for delayed clamping.…”

Section: Discussionmentioning

confidence: 67%

Delayed Versus Immediate Cord Clamping in Preterm Infants

Tarnow‐Mordi

¹

,

Morris

²

,

Kirby

³

et al. 2018

Obstetrical &Amp; Gynecological Survey

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BACKGROUNDThe preferred timing of umbilical-cord clamping in preterm infants is unclear. METHODSWe randomly assigned fetuses from women who were expected to deliver before 30 weeks of gestation to either immediate clamping of the umbilical cord (≤10 seconds after delivery) or delayed clamping (≥60 seconds after delivery). The primary composite outcome was death or major morbidity (defined as severe brain injury on postnatal ultrasonography, severe retinopathy of prematurity, necrotizing enterocolitis, or late-onset sepsis) by 36 weeks of postmenstrual age. Analyses were performed on an intention-to-treat basis, accounting for multiple births. RESULTSOf 1634 fetuses that underwent randomization, 1566 were born alive before 30 weeks of gestation; of these, 782 were assigned to immediate cord clamping and 784 to delayed cord clamping. The median time between delivery and cord clamping was 5 seconds and 60 seconds in the respective groups. Complete data on the primary outcome were available for 1497 infants (95.6%). There was no significant difference in the incidence of the primary outcome between infants assigned to delayed clamping (37.0%) and those assigned to immediate clamping (37.2%) (relative risk, 1.00; 95% confidence interval, 0.88 to 1.13; P = 0.96). The mortality was 6.4% in the delayed-clamping group and 9.0% in the immediate-clamping group (P = 0.03 in unadjusted analyses; P = 0.39 after post hoc adjustment for multiple secondary outcomes). There were no significant differences between the two groups in the incidences of chronic lung disease or other major morbidities. CONCLUSIONSAmong preterm infants, delayed cord clamping did not result in a lower incidence of the combined outcome of death or major morbidity at 36 weeks of gestation than immediate cord clamping.

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“…Well-conducted randomized controlled trials (RCTs) are considered to be the pinnacle of scientific evidence for the effectiveness and safety of interventions in medicine. 1 On the other hand, biased RCTs can lead to use of unnecessary, or even harmful, interventions. 2 RCTs and meta-analyses of RCTs are often the basis for changes in national and international guidelines.…”

Section: Introductionmentioning

confidence: 99%