EUCTR2015-003177-14-ES
Active, not recruiting
Phase 1
Paracetamol versus ibuprofen in preterm infants with a hemodynamically significant patent ductus arteriosus: a randomized clinical trial.
Not provided0 sitesApril 20, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Persistent ductus arteriosus haemodynamically significant
- Sponsor
- Not provided
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •? Informed consent signed by parents or legal representative.
- •? Gestational age ? 30 weeks.
- •? Postnatal age ? 2 weeks
- •? 1st episode of hemodynamically significant PDA diagnosed by ultrasound:
- •1\. Continuous flow through DAP.
- •2\. Retrograde diastolic flow in the descending aorta.
- •3\. Strain the left atrium. (relationship left atrium / aorta (LA / AO)\> 1\.5\).
- •4\. Ductal diameter greater than 1\.7 mm.
- •5\. Relationship ductus / descending aorta diameter size greater than 0\.5\.
- •? Need for ventilatory support
Exclusion Criteria
- •\- Gestational age\> 30 weeks
- •\- Postnatal age\> 2 weeks
- •\- Major congenital malformations.
- •\- Impending doom.
- •\- Chromosomopaties.
- •\- Refusal to participate and / or sign the informed consent.
- •\- Inability to randomization or scrambling wrong.
- •\- Participation in another clinical trial
- •\- Diuresis less than 1 ml / kg / h for 8 h prior to treatment
- •\- Greater than 1\.8 mg / dl Creatinine
Outcomes
Primary Outcomes
Not specified
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