PDA Tolerate Trial. PDA: TO LEave it alone or Respond And Treat Early
Research type
Research Study
Full title
"Trial of Early Treatment of the patent ductus arteriosus versus Conservative Treatment" (PDA – Tolerate Trial: PDA: TO LEave it alone or Respond And Treat Early - Trial)
IRAS ID
159807
Contact name
Anne Marie Heuchan
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 31 days
Research summary
A ductus arteriosus is a blood vessel essential to the circulation of babies in the womb which should close shortly after birth. Failure of constriction is common in premature babies, and is described as a Patent Ductus Arteriosus (PDA). This occurs in approximately 80% of babies born extremely prematurely and may take months to close. The effects of the PDA can be to allow blood from the circulation back to the heart and lungs causing heart failure and disturbance of normal organ blood supply. A PDA can be closed medically with drugs such as ibuprofen, indomethacin and paracetamol but these treatments have potential side effects in preterms such as renal impairment, gastric perforation, necrotising enterocolitis and bleeding tendencies. PDA can be closed surgically if medicines fail but the potential risks and harms are greater. However, there is increasing evidence that babies can survive to discharge without closing the PDA and there is no real evidence of benefit from treating a PDA. Increasingly many clinicians are concerned that we may be unecessarilly exposing babies to potentially harmful treatments whilst others are concerned that not treating the PDA may expose the baby to heart failure for several weeks and increase the chances of some babies requiring surgical closure of the PDA. Despite considerable research managing the PDA remains controversial. This trial is a multicentre randomised study aiming to address some of these questions. The primary goal of this trial is to compare two different Patent Ductus Arteriosus (PDA) treatment approaches: 1) an "early treatment" approach or 2) a "conservative" approach with only supportive treatment in very premature babies born < 28 weeks who have a moderate/large PDA present at 5-7 days after birth and to see which approach is best tolerated.
REC name
West of Scotland REC 3
REC reference
14/WS/1090
Date of REC Opinion
20 Nov 2014
REC opinion
Further Information Favourable Opinion