To evaluate the feasibility of recruiting preterm infants to a randomized controlled
trial of patent ductus arteriosus (PDA) treatment based on a PDA severity score (PDAsc)
and to characterize challenges in obtaining consent, compliance with the protocol,
and PDA closure rates.
This was a single center, randomized control pilot study of 60 infants <29 weeks’
gestation with a high PDAsc (≥5.0) at 36–48 hours of age receiving either Ibuprofen
or Placebo intravenously. The study protocol did not allow for additional PDA therapy
within the first two weeks. We reported the rate of consent, open label treatment
and PDA closure rates. The primary outcome was chronic lung disease/Death.
83 families were approached for enrollment with 73 (88%) providing consent; 13 infants
had a PDAsc < 5; of the remaining infants, 30 were assigned Ibuprofen and 30 received
placebo. Eight infants received open label treatment in the first two weeks (12%).
The overall PDA closure rate after treatment was 57% in the Intervention Group and
17% in the Control Group (p<0.01). There was no difference in the primary clinical
outcome (odds ratio 0.8, 95% confidence interval 0.3–2.1).
Using a PDA severity score for infant recruitment to a PDA treatment RCT is feasible.
There is a high rate of consent and relatively low rate of open label PDA treatment.
The overall PDA closure rate in the intervention arm was low placing the emphasis
on devising more effective PDA closure strategies in future RCTs.
ISRCTN (13281214) and European Union Drug Regulating Authorities Clinical Trials Database