EUCTR2013-005336-23-GB
Active, not recruiting
Phase 1
Outcome After Selective Early Treatment for Closure of Patent Ductus Arteriosus in Pre-term Babies - Baby-OSCAR Trial
ConditionsPatent ductus arteriosus of the newbornTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsPedea
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patent ductus arteriosus of the newborn
- Sponsor
- niversity of Oxford
- Enrollment
- 730
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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