Sangtawesin 2006.
| Methods | I. Blinding of randomisation ‐ yes; infants were randomly assigned to ibuprofen or control group by block randomisation II. Blinding of intervention ‐ yes III. Complete follow‐up ‐ yes IV. Blinding of outcome measurement(s) ‐ yes | |
| Participants | Study period: July 2003 to April 2004 This single‐centre trial conducted in Thailand enrolled 42 infants of 28 to 32 weeks' gestational age and birth weight ≤ 1500 g and postnatal age < 24 hours Prophylactic ibuprofen group: N = 22 Postmenstrual age (weeks): 30.64 ± 1.76 Birth weight (g): 1279.64 ± 80.33 Control group: N = 20 Postmenstrual age (weeks): 30.20 ± 2.14 Birth weight (g): 1214.50 ± 217.52 |
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| Interventions | The prophylaxis group received ibuprofen suspension (Junifen, Boots Company, Thailand) at a dosage of 10 mg/kg via an orogastric tube, followed by 0.5 mL of distilled water. The first dose was given within the first 24 hours of life. The second and third doses were given within 24 and 48 hours after the first dose, respectively. Participants in the control group were given 3 doses of an orange starch suspension as placebo that looked like ibuprofen | |
| Outcomes | The primary outcome was presence of a PDA (defined as echocardiographic evidence of a haemodynamically significant PDA) on day 3 of treatment Additional outcomes included neonatal mortality, duration of mechanical ventilation, pulmonary hypertension, NEC, gastrointestinal haemorrhage, time to full enteral feeds, ROP (grades not stated), length of hospital stay, BPD (age at diagnosis not stated), days of supplemental oxygen therapy, days of mechanical ventilation, IVH (grades not stated), need for rescue treatment with indomethacin or ibuprofen, and PPHN |
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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 into the present study and control group by block randomisation" |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Participants in the control group were given 3 doses of an orange starch suspension as placebo that looked like ibuprofen. Medical personnel who took care of the patients were blind to group assignment. 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 |