Summary of findings 2. Prophylactic administration of paracetamol versus placebo or no intervention for patent ductus arteriosus.

Prophylactic administration of paracetamol (oral or IV) versus placebo (IV) or no intervention for patent ductus arteriosus
Patient or population: preterm infants with patent ductus arteriosus Settings: Neonatal intensive care units Intervention: paracetamol 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	Paracetamol
Failure of ductal closure after 4 to 5 days of treatment PDA diagnosed by ECHO	High risk population		RR 0.49 (0.24 to1.00)	80 (2)	⊕⊕⊝⊝ low	Bias: the study by Härkin 2016 was of the highest quality and with no concerns about bias. For the study by Asbagh 2015 allocation concealment was unclear as was the blinding of personnel and outcome assessments and possible reporting bias. We downgraded the quality by 1 step. Heterogeneity/Consistency: we noted no heterogeneity (I² = 0% for both RR and RD). Directness of evidence: studies were conducted in the target population. Precision: because of the small sample size (80 infants), the point estimate although not statistically significant for RR was significant for RD. The confidence interval was wide. We downgraded the quality by 1 step. Presence of publication bias: as only 2 studies were included we did not construct a funnel plot.
	415 per 1000	205 per 1000 (174 to 250)
Death Clinical assessment	High risk population		RR 0.35 (0.04 to 3.20)	80 (2)	⊕⊕⊕⊝ moderate	Bias: we had no concerns regarding the assessment of mortality. Heterogeneity/Consistency: we noted no heterogeneity (I² = 0% for both RR and RD). Directness of evidence: studies were conducted in the target population. Precision: because of the small sample size (80 infants), the point estimate was not precise with a wide 95% CI. We downgraded the quality of the evidence by 1 step. Presence of publication bias: as only 3 studies were included we did not perform a funnel plot.
	49 per 1000	0 per 1000 0 to )
*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.