Summary of findings 2. Sildenafil compared with active control for pulmonary hypertension in neonates.
Sildenafil compared with active control for pulmonary hypertension in neonates | ||||||
Patient or population: pulmonary hypertension in neonates Setting: neonatal intensive care unit Intervention: sildenafil Comparison: magnesium sulphate | ||||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No. of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Risk with magnesium sulphate | Risk with sildenafil | |||||
All‐cause mortality | Study population | RR 0.55 (0.05 to 5.75) | 65 (1 RCT) | ⊕⊝⊝⊝ VERY LOWa,b | Evidence was downgraded due to very serious imprecision, as results from this single study have not been replicated and risk of bias is evident in study design (missing data) | |
59 per 1000 | 32 per 1000 (3 to 338) | |||||
*The risk in the intervention group (and its 95% confidence interval) is based on assumed risk in the comparison group and relative effect of the intervention (and its 95% CI) CI: confidence interval; MD: mean difference; RR: risk ratio | ||||||
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect |
aImprecise due to small sample size; only one included study
bRisk of bias due to missing data (not analysed as intent to treat)