Clinical trial to evaluate the impact on the intestinal prognosis of 2 ibuprofen administration regimens for the treatment of patent ductus arteriosus, guided by echocardiography

Phase 1

• Conditions: patent ductus arteriosus; MedDRA version: 19.0Level: PTClassification code 10034130Term: Patent ductus arteriosusSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2016-002974-11-ES
• Lead Sponsor: María Carmen Bravo Laguna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-26
• Last Update Posted: 21 November 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Preterm infants less than 33 weeks gestational age
2. PDA = 1.5 mm and medical decision to start drug treatment
3. Signed informed consent by the legal representative
Are the trial subjects under 18? yes
Number of subjects for this age range: 180
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Consent Denied
2. Presence of severe birth defects
3. Congenital Heart Disease
4. Contraindication for administration of IB:
• oligoanuria (diuresis <1 cc / kg / h)
• recent severe intraventricular bleeding (IVH grade III or extensive periventricular hemorrhagic infarction)
• Serum creatinine> 1.5 mg / dl or clinical suspicion of intestinal ischemia.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified