None listed
Conditions
Brief summary
Preterm birth continues to be a major health problem throughout the world. Very preterm babies have to adapt to their new extra uterine environment to be able to survive, often with increased risks of abnormal neurodevelopmental outcomes in later life. A patent ductus arteriosus (PDA) is a frequent cardiovascular complication in this patient group, and many would receive treatment with either medication or surgical closure. However, meta-analysis of trials showed no improvement in clinical outcomes, even though PDA was reduced. It is possible that the treatment received is causing more harm than benefit or treatment is being directed at the wrong patient subgroups. A definitive trial, comparing current standard treatment (pharmacological treatment with supportive care) versus supportive care alone, is necessary to resolve doubts regarding the quality or conduct of prior studies. We hypothesise that there will be comparable outcomes between the 2 approaches, and that this data will support the start of a larger trial using neonatal and cardiology collaboration networks. The proposed study design where no open label pharmacological treatment is allowed will be able to describe the natural course of a PDA in preterm infants in the current era of perinatal care. It will allow for detailed prospective study of the PDA using conventional and novel echocardiography techniques to address the issue of which patient subgroups may benefit from treatment.
Interventions
Non steroidal anti inflammatory drugs (NSAID) combined with supportive care
This is a pragmatic study evaluating NSAID therapy with supportive care versus supportive care alone in the management of PDA. Both commonly used NSAID preparations will be eligible and can be used according to current local guidelines. Indomethacin is known to be more effective in very early treatment (<24h). Ibuprofen has a better side effect profile when used in early treatment (24-72h). The standard recommended dose
Non steroidal anti inflammatory drugs (NSAID) combined with supportive care This is a pragmatic study evaluating NSAID therapy with supportive care versus supportive care alone in the management of PDA. Both commonly used NSAID preparations will be eligible and can be used according to current local guidelines. Indomethacin is known to be more effective in very early treatment (<24h). Ibuprofen has a better side effect profile when used in early treatment (24-72h). The standard recommended dose and interval are Indomethacin iv 0.2-0.1-0.1 mg/kg with 24 hour intervals Ibuprofen iv 10-5-5 mg/kg with 24 hour intervals Supportive care includes optimizing airway pressure, careful fluid management with or without the use of diuretics as per current standard practice. No directive guideline is provided with this study, as none of these supportive care measures have been rigorously tested.
Sponsors
Hunter Medical Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to 72 Hours
Healthy volunteers
No
Inclusion criteria
Preterm infants less than 29 weeks gestation PDA diameter > 1.5 mm <72 hours of age
Exclusion criteria
significant active haemorrhage (pulmonary, IVH grade 3 or 4, other) at randomization major congenital heart disease significant other congenital abnormalities absolute contraindications for indomethacin or ibuprofen
Outcome results
None listed