Double blind randomized controlled study on the benefit-risk profile of in the treatment of at term or late preterm newborn infants with severe respiratory disorders and pulmonary hypertension - SILDENAFIL AND PULMONARY HYPERTENSION OF NEWBORNS

Active, not recruiting

• Conditions: treatment of at term or late preterm newborn infants with severe respiratory disorders and pulmonary hypertension; Level: PTClassification code 10037400

• Registration Number: EUCTR2007-005513-18-IT
• Lead Sponsor: OSPEDALE PEDIATRICO BAMBINO GESU' DI ROMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-11
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

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

Inclusion Criteria

neonates ≥34 weeks of gestational age hospitalized in neonatal intensive care units (NICU) within the first week of life with acute respiratory failure of any origin, who require mechanical ventilation, either conventional (tidal) or high frequency oscillatory (HFOV), with an OI ≥10 and echocardiographic evidence of PH.
Are the trial subjects under 18? yes
Number of subjects for this age range:
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

major malformation, genetic/chromosomic anomalies incompatible with life or with increased risk of unfavorable neurological outcome, systemic hypotension (mean arterial blood pressure <2 SD the average value for birth weight [8], intracranial hemorrhage, previous iNO exposure.

Study & Design

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