3.
| Ibuprofen (IV) compared with placebo or no intervention for prevention of PDA | ||||||
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Patient or population: preterm or low birth weight infants with risk of having PDA on day 3 to 4 of life Settings: NICU Intervention: ibuprofen (IV) Comparison: placebo or no intervention | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No. of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Placebo or no intervention | Ibuprofen (IV) | |||||
| Presence of PDA on third day of life (72 hours of treatment) | High‐risk population | 0.37 (0.29 to 0.47) | 827 (5 studies) |
⊕⊕⊕⊕ high | Design (risk of bias): risk of bias for random sequence generation was low in 1 study and unclear in 4 studies; risk of bias for allocation concealment was low in 4 studies and unclear in 2 study; risk of bias regarding performance bias and detection bias was low in 3 studies and unclear in 2 studies Heterogeneity/consistency: across studies: heterogeneity was low for RR (I² = 34%) but moderate for RD (I² = 53%) Directness of the evidence: studies were conducted in the target population Precision of estimates: 827 infants have been enrolled in the studies to date, and confidence intervals around the point estimates for RR and RD were narrow Presence of publication bias: we did not perform a funnel plot for this outcome as only 5 trials were included in the analyses |
|
| 427 per 1000 | 158 per 1000 (124 to 201) | |||||
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; IV: intravenous; NICU: neonatal intensive care unit; PDA: patent ductus arteriosus; RD: risk difference; RR: risk ratio. | ||||||
| GRADE Working Group grades of evidence. High quality: further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: we are very uncertain about the estimate. | ||||||