Baby-OSCAR (Baby Outcomes after Selective early targeted treatment for Closure of 'open' ductus ARteriosus in preterm babies)
- Conditions
- Patent ductus arteriosus of the newbornTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2013-005336-23-GB
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 730
Babies will be considered eligible for inclusion into the study if they are;
• Born at 23+0 to 28+6 weeks of gestation
• Less than 72 hours old
• Confirmed by echocardiography to have a large PDA which
oIs = 1.5 mm in diameter (determined by gain optimised colour Doppler)
oHas unrestrictive pulsatile left to right flow
In addition:
The responsible clinician is uncertain about whether this baby might benefit from treatment to close the PDA
Written informed consent has been obtained from the parent(s)
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Babies will be excluded from participation in the study if they have;
• No realistic prospect of survival
• Severe congenital anomaly
• Structural heart disease requiring treatment
• Other conditions that would contraindicate the use of ibuprofen (intracranial or gastrointestinal haemorrhage, coagulopathy, thrombocytopenia (platelet count <50,000), renal failure, pulmonary hypertension, known or suspected necrotising enterocolitis)
• Antenatal treatment with a COX inhibitors
• Received indomethacin, ibuprofen or paracetamol after birth.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method