Summary

at UC Davis
study started
estimated completion

Description

Summary

This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide treatment and reduce the failure rate of available treatments for persistent pulmonary hypertension of the newborn.

Official Title

A MULTI-CENTRE, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, TWO-ARMED, PARALLEL GROUP STUDY TO EVALUATE EFFICACY AND SAFETY OF IV SILDENAFIL IN THE TREATMENT OF NEONATES WITH PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN (PPHN) OR HYPOXIC RESPIRATORY FAILURE AND AT RISK FOR PPHN, WITH A LONG TERM FOLLOW-UP INVESTIGATION OF DEVELOPMENTAL PROGRESS 12 AND 24 MONTHS AFTER COMPLETION OF STUDY TREATMENT

Keywords

Pulmonary Hypertension, Familial Persistent, of the Newbornpersistent pulmonary hypertensionnewbornneonatesiv sildenafilhypoxic respiratory failure and at risk of persistent pulmonary hypertension of the newbornHypertensionHypertension, PulmonaryRespiratory InsufficiencyPersistent Fetal Circulation SyndromeSildenafil Citratesildenafil

Eligibility

You can join if…

  • Neonates with persistent pulmonary hypertension of the newborn
  • Age <=96 hours and >=34 weeks gestational age
  • Oxygenation Index >15 and <60
  • Concurrent treatment with inhaled nitric oxide and >=50% oxygen

You CAN'T join if...

  • Prior or immediate need for extracorporeal membrane oxygenation or cardiopulmonary resuscitation
  • Expected duration of mechanical ventilation <48 hours
  • Profound hypoxemia
  • Life-threatening or lethal congenital anomaly

Locations

  • University of California Davis Medical Center
    SacramentoCalifornia95817United States
  • University of California Davis
    SacramentoCalifornia95817United States
  • University of California Davis Medical Center
    SacramentoCalifornia95825United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT01720524
Phase
Phase 3
Study Type
Interventional
Last Updated