Lally 2006.
Methods | RCT. | |
Participants | All women with fetus shown to have CDH prior to 34 weeks. | |
Interventions | Intervention: Betamethasone (12.5 mg) 2 doses 24 hours apart (given at 34 weeks) followed by 2 weekly doses. Control: placebo (the composition of the placebo was not stated in the trial report). |
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Outcomes | Mortality, ventilator days, need for oxygen at 30 days, length of hospital stay, birth data, Apgar scores, treatments received. | |
Notes | Women were randomised women from participating hospitals in the US, Italy, Germany and Australia. This trial was partly funded by NIH grants K24RR17050 and M01RR002558. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "central randomisation centre." |
Allocation concealment (selection bias) | Unclear risk | Not stated other than "central randomisation centre". |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "Investigators were blinded", no other mention of blinding. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "Investigators were blinded", no other mention of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | One woman in each group withdrew with outcome data not available, analysis by intention‐to‐treat. |
Selective reporting (reporting bias) | Low risk | No apparent selective reporting. |
Other bias | Low risk | Stopped early as interim analysis suggested unlikely that sufficient patients would be enrolled to determine an outcome. No apparent baseline differences. |