| Methods |
Two centres, UK. (September 1985 to July 1989), randomized controlled trial without the use of a placebo.
I. Blinding of randomization:
‐ yes (sealed envelopes)
II. Blinding of intervention: no
III. Complete follow‐up: yes
IV. Blind outcome assessment: no |
| Participants |
121 infants weighing less than 2,500 grams at birth with clinical signs of persistent ductus arteriosus who required indomethacin treatment.
BW (mean +/‐ SD) 1116 +/‐ 340 g, GA 27 +/‐ 2.2 wk, age at indomethacin therapy: < 7 days(n = 32), >/= 7 days (n = 27 days) (prolonged low dose group) versus BW 1135 +/‐ 340 g, GA 27 +/‐ 2.2 wk, age at indomethacin therapy: < 7 days(n = 39), >/= 7 days (n = 23 days) (conventional dose group) |
| Interventions |
Prolonged course: 6‐ day course (0.1 mg/kg/dose IV) (n=59). Short course: 3 doses at intervals of 12 hours of 0.2 mg/kg IV (n=62). The course was completed unless the treatment was stopped because of a complication. |
| Outcomes |
Primary: response to treatment (PDA closure)
Other: relapse after treatment (PDA re‐opening), retreatment, rise in serum urea or creatinine concentration, reduction of inspired oxygen at 6 days, death, side effects (GI hemorrhage, GI perforation, bleeding, acute renal failure). |
| Notes |
Echocardiography was not available in either centre at the time of this study.
Relapse was defined as a recurrence of systolic murmur and increased pulse volume.
Indomethacin dosage for retreatment was not specified.
There were a total of three PDA ligations, but treatment allocation was not clear.
Same total dose of indomethacin was given in two different ways.
Increased mortality from BPD with prolonged course could be explained by the significantly higher baseline oxygen requirement in this group. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
