Sangtawesin 2008.
| Methods | I. Blinding of randomisation ‐ cannot tell; infants were randomly assigned to ibuprofen or control by block randomisation II. Blinding of intervention ‐ yes; medical personnel who took care of patients were blind to group assignment III. Complete follow‐up ‐ yes IV. Blinding of outcome measurement(s) ‐ yes | |
| Participants | Study period: October 2005 to October 2006 This single‐centre trial conducted in Thailand enrolled 62 infants with birth weight < 1500 g and postnatal age < 24 hours. The infants were known to have a PDA diagnosed by echocardiography on entry into the trial Prophylactic ibuprofen group: N = 31 Postmenstrual age (weeks): 29.32 ± 1.94 Birth weight (g): 1156.90 ± 263.6 Placebo group: N = 31 Postmenstrual age (weeks): 29.29 ± 2.16 Birth weight (g): 1162.90 ± 261.0 |
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| Interventions | The prophylaxis group received 3 doses of oral ibuprofen suspension (Junifen, Boots Company, Thailand) at a dosage of 10 mg/kg for the first dose within 24 hours of life, and 5 mg/kg for the second and third doses after 24 and 48 hours. The drug was given via an orogastric tube, followed by 0.5 mL of distilled water. Infants in the control group received 3 doses of orange starch suspension as placebo administered by the same method and time schedule as oral ibuprofen suspension in the study group. The external appearance of placebo was like ibuprofen suspension and could not be differentiated by naked eyes | |
| Outcomes | The primary outcome was closure of PDA (defined as lack of echocardiographic evidence of a haemodynamically significant PDA) on day 3 of treatment Other outcomes included PPHN, BPD, days of assisted ventilation, days on supplemental oxygen, serum BUN on day 3, serum creatinine on day 3, days to start feeding, days to reach full feeds, gastrointestinal bleeding, NEC ≥ stage 2, ROP (total and stage 1 and stage 2), IVH (grade I and grades I to III), length of hospital stay (days), and mortality during the study period (28 days) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information provided |
| Allocation concealment (selection bias) | Unclear risk | "Patients were randomly assigned" |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Infants in the control group received 3 doses of orange starch suspension as placebo administered by the same method and time schedule as oral ibuprofen suspension in the study group. The external appearance of placebo was like ibuprofen suspension and could not be differentiated by naked eyes. Risk for performance and detection bias was low |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes reported for all randomised infants |
| Selective reporting (reporting bias) | Unclear risk | The trial was not registered in a trials registry, and we could not ascertain if there were deviations from the original protocol in the final publication |
| Other bias | Low risk | Appears free of other bias |