Cochrane · systematic review · CD010061
Paracetamol (acetaminophen) for patent ductus arteriosus in preterm or low birth weight infants
Jasani, B, Mitra, S, Shah, PS · Cochrane Database of Systematic Reviews · 2022 · Cochrane Library
SoF tableOnly the outcomes this review put in its Summary of Findings table are listed (the Cochrane Handbook caps them at about seven per comparison). Its other analyses are not shown here.
Questions
18
current version
GRADE rated
13
No studies
5
Included studies
NR
No studies 5 · 27.8%Ungraded 0 · 0%Very low 0 · 0%Low 10 · 55.6%Moderate 3 · 16.7%High 0 · 0%
Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.
Questions and results
Current version onlyParacetamol versus ibuprofen for PDA in preterm or low birth weight infants
Population: preterm or low birth weight infants with PDA
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure of PDA closure after first course of treatment (assessed by post‐treatment ECHO) Paracetamol vs ibuprofen | RR 1.02 [0.88, 1.18] | 18 studies · 1535 participants | Moderate Downgraded: risk of bias |
All‐cause mortality during initial hospital stay(by clinical assessment) Paracetamol vs ibuprofen | RR 1.09 [0.8, 1.48] | 8 studies · 734 participants | Moderate Downgraded: risk of bias |
Necrotizing enterocolitisduring initial hospital stay (by radiological diagnosis) Paracetamol vs ibuprofen | RR 1.3 [0.87, 1.94] | 10 studies · 1015 participants | Moderate Downgraded: risk of bias |
Paracetamol versus indomethacin for PDA in preterm or low birth weight infants
Population: preterm infants with PDA
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure of PDA closure after first course of treatment (assessed by post‐treatment ECHO) Paracetamol vs indomethacin | RR 1.02 [0.78, 1.33] | 4 studies · 380 participants | Low Downgraded: risk of bias, inconsistency |
All‐cause mortality during initial hospital stay (by clinical assessment) Paracetamol vs indomethacin | RR 0.86 [0.39, 1.92] | 2 studies · 114 participants | Low Downgraded: risk of bias, imprecision |
Necrotizing enterocolitis during initial hospital stay (by radiological diagnosis) Paracetamol vs indomethacin | RR 0.42 [0.19, 0.96] | 4 studies · 384 participants | Low Downgraded: risk of bias, imprecision |
Prophylactic administration of paracetamol versus placebo or no intervention for PDA in preterm or low birth weight infants
Population: preterm infants with PDA
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure of PDA closure after first course (assessed by post‐treatment ECHO) Prophylactic administration of paracetamol vs placebo or no intervention | RR 0.27 [0.18, 0.42] | 3 studies · 240 participants | Low Downgraded: risk of bias, inconsistency |
All‐cause mortality during initial hospital stay (by clinical assessment) Prophylactic administration of paracetamol vs placebo or no intervention | RR 0.59 [0.24, 1.44] | 3 studies · 240 participants | Low Downgraded: risk of bias, imprecision |
Necrotizing enterocolitis during initial hospital stay (by radiological diagnosis) Prophylactic administration of paracetamol vs placebo or no intervention | no estimate extracted | NR | No studies |
Early paracetamol versus placebo/no intervention for PDA in preterm or low birth weight infants
Population: preterm or low birth weight infants with PDA
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure of PDA closure after first course of treatment (by post‐treatment ECHO) Early paracetamol vs placebo/no intervention | RR 0.35 | 2 studies · 127 participants | Low Downgraded: risk of bias, inconsistency |
All‐cause mortality during initial hospital stay (by clinical assessment) Early paracetamol vs placebo/no intervention | no estimate extracted | NR | No studies |
Necrotizing enterocolitis during initial hospital stay (by radiological diagnosis) Early paracetamol vs placebo/no intervention | no estimate extracted | NR | No studies |
Late paracetamol versus placebo/no intervention for PDA in preterm or low birth weight infants
Population: preterm or low birth weight infants with PDA
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure of PDA closure after first course of treatment (assessed by post‐treatment ECHO) Late paracetamol vs placebo/no intervention | RR 0.85 [0.72, 1.01] | 1 study · 55 participants | Low Downgraded: imprecision, indirectness |
All‐cause mortality during initial hospital stay (by clinical assessment) Late paracetamol vs placebo/no intervention | no estimate extracted | NR | No studies |
Necrotizing enterocolitis during initial hospital stay (by radiological diagnosis) Late paracetamol vs placebo/no intervention | RR 1.04 [0.07, 15.76] | 1 study · 55 participants | Low Downgraded: imprecision, indirectness |
Paracetamol plus ibuprofen (oral or IV) versus ibuprofen plus placebo (oral or IV) or no intervention for PDA in preterm or low birth weight infants
Population: preterm or low birth weight infants with PDA
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure of PDA closure after first course of treatment (assessed by post‐treatment ECHO) Paracetamol plus ibuprofen (oral or IV) vs ibuprofen plus placebo (oral or IV) or no intervention | RR 0.77 [0.43, 1.36] | 2 studies · 111 participants | Low Downgraded: risk of bias, imprecision |
All‐cause mortality during initial hospital stay (by clinical assessment) Paracetamol plus ibuprofen (oral or IV) vs ibuprofen plus placebo (oral or IV) or no intervention | no estimate extracted | NR | No studies |
Necrotizing enterocolitis during initial hospital stay (radiological diagnosis) Paracetamol plus ibuprofen (oral or IV) vs ibuprofen plus placebo (oral or IV) or no intervention | RR 0.33 [0.01, 7.45] | 1 study · 24 participants | Low Downgraded: risk of bias, imprecision |
Paracetamol compared to ibuprofen for patent ductus arteriosus in preterm or low birth weight infants
Population: preterm or low birth weight infants with patent ductus arteriosus
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure of ductal closure after the first course of treatment Echocardiogram Paracetamol vs ibuprofen | RR 0.95 [0.75, 1.21] | 5 studies · 559 participants | Moderate |
All‐cause mortality during initial hospital stay Clinical assessment, no risk of bias Paracetamol vs ibuprofen | RR 0.96 [0.55, 1.67] | 3 studies · 272 participants | Moderate |
Neurodevelopmental impairment Clinical assessments by assessors blinded to group assignment, no risk of bias Paracetamol vs ibuprofen | RR 0.93 [0.44, 1.96] | 1 study · 61 participants | Low |
Gastrointestinal bleed or stools positive for occult blood Paracetamol vs ibuprofen | RR 0.28 [0.12, 0.69] | 4 studies · 537 participants | Moderate |
Serum levels of creatinine after treatment (µmol/L) Serum samples Paracetamol vs ibuprofen | no estimate extracted | 4 studies · 537 participants | Moderate |
Prophylactic administration of paracetamol versus placebo or no intervention for patent ductus arteriosus
Population: preterm infants with patent ductus arteriosus
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure of ductal closure after 4 to 5 days of treatment PDA diagnosed by ECHO Prophylactic administration of paracetamol vs placebo or no intervention | RR 0.49 [0.24, 1] | 2 studies · 80 participants | Low |
Death Clinical assessment Prophylactic administration of paracetamol vs placebo or no intervention | RR 0.35 [0.04, 3.2] | 2 studies · 80 participants | Moderate |
Paracetamol compared with indomethacin for patent ductus arteriosus
Population: preterm infants with patent ductus arteriosus
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure to close a PDA Assessed by ECHO Paracetamol vs indomethacin | RR 0.96 [0.55, 1.65] | 2 studies · 273 participants | Moderate |
Paracetamol compared to ibuprofen for patent ductus arteriosus in preterm or low birth weight infants
Population: preterm or low birth weight infants with patent ductus arteriosus
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure of ductal closure after the first course of treatment Echocardiogram Paracetamol vs ibuprofen | RR 0.95 [0.75, 1.21] | 5 studies · 559 participants | Moderate |
All‐cause mortality during initial hospital stay Clinical assessment, no risk of bias Paracetamol vs ibuprofen | RR 0.96 [0.55, 1.67] | 3 studies · 272 participants | Moderate |
Neurodevelopmental impairment Clinical assessments by assessors blinded to group assignment, no risk of bias Paracetamol vs ibuprofen | RR 0.93 [0.44, 1.96] | 1 study · 61 participants | Low |
Gastrointestinal bleed or stools positive for occult blood Paracetamol vs ibuprofen | RR 0.28 [0.12, 0.69] | 4 studies · 537 participants | Moderate |
Serum levels of creatinine after treatment (µmol/L) Serum samples Paracetamol vs ibuprofen | no estimate extracted | 4 studies · 537 participants | Moderate |
Prophylactic administration of paracetamol versus placebo or no intervention for patent ductus arteriosus
Population: preterm infants with patent ductus arteriosus
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure of ductal closure after 4 to 5 days of treatment PDA diagnosed by ECHO Prophylactic administration of paracetamol vs placebo or no intervention | RR 0.49 [0.24, 1] | 2 studies · 80 participants | Low |
Death Clinical assessment Prophylactic administration of paracetamol vs placebo or no intervention | RR 0.35 [0.04, 3.2] | 2 studies · 80 participants | Moderate |
Paracetamol compared with indomethacin for patent ductus arteriosus
Population: preterm infants with patent ductus arteriosus
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure to close a PDA Assessed by ECHO Paracetamol vs indomethacin | RR 0.96 [0.55, 1.65] | 2 studies · 273 participants | Moderate |
Oral paracetamol compared to oral ibuprofen for patent ductus arteriosus in preterm or low‐birth‐weight infants
Population: patients with patent ductus arteriosus in preterm or low‐birth‐weight infants
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Failure of ductal closure after the first course of treatment Echocardiogram Oral paracetamol vs oral ibuprofen | RR 0.9 [0.67, 1.22] | 2 studies · 250 participants | Low Downgraded: imprecision |
All‐cause mortality during initial hospital stay Clinical assessment, no risk of bias Oral paracetamol vs oral ibuprofen | RR 0.95 [0.52, 1.72] | 2 studies · 250 participants | Moderate Downgraded: imprecision |
Surgical closure of the PDA following treatment failure with paracetamol or ibuprofen Surgery Oral paracetamol vs oral ibuprofen | RR 0.5 [0.05, 5.32] | 1 study · 90 participants | Moderate Downgraded: imprecision |
Severe IVH (Grade III‐IV) Ultrasound Oral paracetamol vs oral ibuprofen | RR 1 [0.3, 3.37] | 2 studies · 250 participants | Moderate Downgraded: imprecision |
Necrotizing enterocolitis Clinical assessment and radiography Oral paracetamol vs oral ibuprofen | RR 1.5 [0.43, 5.18] | 2 studies · 250 participants | Moderate Downgraded: imprecision |
Oliguria (< 1 cc/kg/hr) Measurement of urine output Oral paracetamol vs oral ibuprofen | no estimate extracted | 2 studies · 250 participants | Moderate Downgraded: imprecision |
Serum levels of creatinine after treatment (mmol/L) Serum samples Oral paracetamol vs oral ibuprofen | no estimate extracted | 2 studies · 250 participants | Ungraded |