Status:
UNKNOWN
Clinical Trial to Evaluate Two Guidelines for the Administration of Ibuprofen in the Treatment of Persistent Ductus Arteriosus Eco-guided: Impact in the Intestinal Prognosis
Lead Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Conditions:
Persistent Ductus Arteriosus
Eligibility:
All Genders
Up to 33 years
Phase:
PHASE3
Brief Summary
Persistent ductus arteriosus (DA) is a common entity in the premature newborn and is associated with high morbidity and mortality. There is still controversy about which is the best treatment for its ...
Eligibility Criteria
Inclusion
- Preterm infants with less 33 weeks of gestational age
- DA ≥ 1.5 mm with decision to start pharmacological treatment
- Informed consent signed by the legal representative
Exclusion
- Consent denied
- Presence of serious congenital alterations
- Congenital heart disease
- Contraindication for the administration of IB: oligoanuria (diuresis \<1cc / kg / h), bleeding severe recent intraventricular (HIV grade III or extensive periventricular hemorrhagic infarction), serum creatinine\> 1.5 mg / dl or clinical suspicion of intestinal ischemia.
Key Trial Info
Start Date :
February 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2020
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04282941
Start Date
February 20 2017
End Date
November 30 2020
Last Update
October 29 2020
Active Locations (3)
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1
Hospital Universitario La Paz
Madrid, Spain, 28046
2
Hospital 12 de Octubre
Madrid, Spain
3
Hospital Quirón Salud Madrid
Madrid, Spain