Baenziger 2007.
Methods | Randomised controlled trial, stratified randomisation list for gestational age group (24‐26, 27‐29, 30‐32 weeks) and mode of birth (vaginal/caesarean). | |
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 4: DCC at 1‐2 mins with baby low (+ gravity) |
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Outcomes | Outcomes: cerebral oxygenation evaluated by NIRS at 4, 24 and 72 hrs of age, mechanical ventilation, death before discharge from hospital. | |
Notes |
Setting: Zurich, Switzerland Dates: September 1996 to July 1997 Declaration of interest: quote:“The authors have indicated they have no financial relationships relevant to this article to disclose.”. Trial funding source: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Part of the same multicentre study as Aladangady 2006. Described as 'selected randomly and assigned to an experimental group or a control group by a central study co‐ordinator'. The uneven group size (15 vs 24) is discussed as being due to central randomisation for a larger study, and the primary outcome for the larger study was not tissue oxygenation (the primary outcome for this report). This suggests that there may have been post randomisation exclusions of babies who did not have tissue oxygenation measured. |
Allocation concealment (selection bias) | Unclear risk | Part of the same multicentre study as Aladangady 2006. Described as 'selected randomly and assigned to an experimental group or a control group by a central study co‐ordinator'. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | For this type of intervention blinding participants and the staff present at delivery to group allocation is not possible. Staff providing care may have modified their behaviour according to randomisation group. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Obstetricians were informed of the study allocation, and it was stated that the neonatologist was not aware of the timing of cord clamping. It is not clear whether outcome assessment was blinded. |
Incomplete outcome data (attrition bias) All outcomes | High risk | There were missing data for some outcomes. |
Selective reporting (reporting bias) | High risk | This study was part of a larger multicentre study. The outcome of tissue oxygenation reported here was collected just for this subset, and the text implies have been post randomisation exclusions of infants who did not have tissue oxygenation measured. The outcomes in the main study were quote:"blood volume, need for red cell transfusion, and respiratory and neurological complications", but these data are not reported. |
Other bias | High risk | Uneven group size although the characteristics of the groups appeared similar. |