Summary of findings 3.
Paracetamol compared with indomethacin for patent ductus arteriosus
| Paracetamol (oral or IV) compared with indomethacin (IV) for patent ductus arteriosus | ||||||
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Patient or population: preterm infants with patent ductus arteriosus Settings: Neonatal intensive care unit Intervention: paracetamol Comparison: indomethacin | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Indomethacin | Paracetamol | |||||
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Failure to close a PDA Assessed by ECHO |
High‐risk population | RR 0.96 (0.55 to 1.65) | 273 (2) | ⊕⊕⊕⊝ moderate | Bias: we had no concerns for random sequence generation or allocation concealment in the 2 included studies. However we did raise concerns regarding blinding of personnel and outcome assessments and for reporting bias our judgement was unclear. We downgraded the quality of evidence on this item by 1 step. Heterogeneity/Consistency: we noted no heterogeneity (I² = 11% for RR and 17% for RD) (none). Directness of evidence: studies were conducted in the target population. Precision: because of the relatively large sample size (237 infants), the point estimate was quite precise with a narrow 95% CI. Presence of publication bias: although only 5 studies were included the funnel plot was symmetrical. |
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| 153 per 1000 | 147 per 1000 (0 to 200) | |||||
| *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% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; 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. | ||||||