Ibuprofen versus indomethacin in the treatment of patent ductus arteriosus (PDA)
| Citation | Study group | Study type (level of evidence) | Outcome | Key results | Comments |
|---|---|---|---|---|---|
| Lago et al (2002) | 175 preterm neonates, GA⩽34 wk, postnatal age 48–72 h with echo proven PDA. Very ill babies excluded. IBU (10 mg/kg iv [time 0], 5 mg/kg iv [time 24,48 h]) v INDO (0.2 mg/kg iv q12 h×3) | RCT (level 1b) Jadad score: 2 | Echo proven closure of PDA. | IBU = INDO for closure of PDA: ARR = 0.043 [95% CI −0.092 to 0.177] | Only echocardiographers were noted to be blinded. Randomisation method not given. Allocation concealment by sealed envelope. |
| Oliguria | INDO more likely to produce oliguria: p = 0.017, NNH = 7 | ||||
| Post-treatment serum creatinine. | INDO resulted in higher post-treatment creatinine (mean 89 μmol/l, SD 24) than IBU (mean 81 μmol/l, SD 20): p = 0.03. | ||||
| Van Overmeire et al (2000) | 148 preterm neonates, GA⩽32 wk, postnatal age 48–96 h with echo proven PDA. Very ill babies excluded. IBU (3 doses) v INDO (3 doses), same doses as above. | RCT (level 1b) Jadad score: 2 | Echo proven closure of PDA | IBU = INDO for closure of PDA: ARR = 0.041 [95% CI −0.109 to 0.19]. | Only echocardiographers were noted to be blinded. Randomisation method not given. Allocation concealment by sealed opaque envelope. |
| Oliguria | INDO more likely to produce oliguria: p = 0.03, NNH = 8 | ||||
| Post-treatment serum creatinine | INDO resulted in higher post-treatment creatinine: p = 0.04. | ||||
| Multiple logistic regression performed to determine predictors of oliguria | Independent predictors of oliguria were INDO treatment, high frequency ventilation, increased serum creatinine days 1–3, and lower ductul shunt velocity. | ||||
| Van Overmeire et al (1997) | 40 preterm neonates, GA⩽33 wk, postnatal age 48–72 h with echo proven PDA. Very ill babies excluded. IBU (3 doses) v INDO (3 doses), same doses as above. | RCT (level 1b) Jadad score: 2 | Echo proven closure of PDA | IBU = INDO for closure of PDA: ARR 0.05 [95% CI −0.208 to 0.308] | Randomisation method not given. Allocation concealment by sealed envelope. No blinding reported. |
| Oliguria | INDO more likely to produce oliguria: p = 0.02, NNH = 3. | ||||
| Post-treatment serum creatinine | IBU = INDO for post-treatment serum creatinine: p = 0.07 | ||||
| Supapannachart et al (2002) | 18 preterm infants (mean GA 30 weeks) with PDA based on clinical and x ray criteria. Very ill babies excluded. IBU (10 mg/kg po od × 3 days) v INDO (0.2 mg/kg po/iv q12 h × 3 doses) | RCT (level 3b) Jadad score: 2 | Clinical closure of PDA | IBU = INDO for closure of PDA: ARR 0.111 [95% CI −0.229 to 0.452] | Randomisation method not given. Allocation concealment by sealed envelope. No blinding reported. INDO group was mixed between babies receiving oral and intravenous treatment; no attempt at subset analysis. |
| Oliguria | No significant difference after day 1. | ||||
| Post-treatment serum creatinine | No significant difference. |