McDonnell 1997.
Methods | Randomised controlled trial, stratified by vaginal or CS, 26 to 29 weeks, 30 to 33 weeks. | |
Participants |
Inclusion criteria
Exclusion criteria
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Interventions |
Intervention: DCC
Comparator: ECC
Additional information
Comparison 1 DCC with neonatal resuscitation after cord clamping vs ECC (subgroup by gestation) Subgroup 1: < 32‐34 weeks' gestation Comparison 2 DCC with neonatal resuscitation after cord clamping vs ECC (subgroup by type intervention) Subgroup 1: DCC at < 1 min with baby level with uterus and placenta |
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Outcomes | Primary outcome: Hct at 4 hrs. Secondary outcomes: Apgar score, temperature on admission, requirement for ventilation, oxygen, surfactant, peak serum bilirubin, inotropic support, cerebral ultrasound, blood transfusion, death | |
Notes |
Setting: Sydney, Australia Dates: January to December 1994 Declaration of interest: not reported Trial funding source: not reported Further information
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Sequence not stated. There was stratification by gestational age and type of delivery. |
Allocation concealment (selection bias) | Unclear risk | Quote: “sealed opaque envelopes”. Not clear if envelopes numbered and used sequentially. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding was not mentioned. It is possible that lack of blinding could influence other aspects of care and the recording of outcomes. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding was not mentioned. It is possible that lack of blinding could influence other aspects of care and the recording of outcomes. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 46 infants were randomised. It was not clear in the publication how many infants were in each randomised group and we understand that personal communication with the authors provided the information and data. For the outcomes, of IVH and PVL there were only 31/46 (67%) of data available though death is reported on all babies. Analysis was according to randomisation group. |
Selective reporting (reporting bias) | Unclear risk | Assessment of risk of bias from published trial report. Several outcomes were not reported in the brief trial report although the authors offer other data on request. We did not assess the trial protocol. |
Other bias | Unclear risk | Groups appeared similar at baseline although there were more boys in the immediate clamping group (15 vs 9, denominators not clear). |