Rabe 2011.
Methods | Randomised controlled trial | |
Participants |
Inclusion criteria
Exclusion criteria
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Interventions |
Intervention: DCC
Comparator: UCM
Additional information
Comparison 5 DCC with neonatal resuscitation after cord clamping vs UCM (subgroup by gestation) Subgroup 1: < 32‐34 weeks' gestation Comparison 6 DCC with neonatal resuscitation after cord clamping vs UCM (subgroup by type of intervention) Subgroup 2: DCC at < 1 min with baby low (+ gravity) |
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Outcomes |
Primary
Secondary
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Notes |
Setting: single tertiary care centre ‐ Royal Sussex County Hospital, Brighton, UK Dates: 2007 to 2009 Declaration of interest: authors reported no potential conflicts of interest. Trial funding source: quote: “Funded by a grant from the Brighton and Sussex University Hospitals Research and Development Directorate.” Also partly funded by National Institute of Health Research under Research for Patient Benefit Programme (PB‐PG‐1208‐18244). Further information
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was based on computer‐created tables performed by a person not involved in the trial. The randomization was stratified by gestational age, 24 0/7 to 27 6/7 completed weeks of gestation and 28 0/7 to 32 6/7 weeks of gestation” |
Allocation concealment (selection bias) | Low risk | Quote: "The randomization allocation cards were kept on the labor ward in sealed opaque envelopes and consecutively numbered. The attending midwife opened the envelope before birth” |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind participants/personnel due to quote: “nature of the interventions” and “routine practice that the neonatal team is directly present in the delivery room”. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unable to blind data collector to allocation group but data retrospectively collected from patient records so difficult to influence numerical data, e.g. Hb or presence/absence of morbidity. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised babies had data available. All exclusions accounted for. No loss to follow‐up and no failures to deliver intended intervention. Except the long‐term follow‐up where data were missing on 14/31 (45%) in DCC and 5/27 (18%) in UCM. Authors report that some parents did not want to come back for the 3.5. year follow‐up. |
Selective reporting (reporting bias) | Unclear risk | All outcomes appear to be reported but 2 and 3.5 year neurological data reported in a later paper (Rabe 2015) and it was unclear in the original paper that these data were to be collected. |
Other bias | Unclear risk | Baseline data on women and babies were similar. Long‐term follow up ‐ data missing on 14/31 (45%) in DCC and 5/27 (18%) in UCM. Authors report that some parents lost interest at 3.5 years as children were doing well and often families were busy. |