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A SINGLE ARM SINGLE CENTRE STUDY TO INVESTIGATE SAFETY AND EFFICACY OF SILDENAFIL IN NEAR TERM AND TERM NEWBORNS WITH PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN (PPHN)

Update Il y a 4 ans
Reference: EUCTR2009-016248-37

Woman and Man

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Extract

Efficacy: determine the efficacy of iv sildenafil in near term and term newborns with PPHN or with hypoxic respiratory failure and at risk for PPHN. The primary measure of efficacy will be the reduced need for iNO and extracorporeal membrane oxygenation ECMO). Safety: to assess the safety and tolerability of iv sildenafil in near term and term newborns with PPHN or with hypoxic respiratory failure and at risk of developing PPHN.

Inclusion criteria

  • Persistent Pulmonary Hypertension of the Newborn (PPHN)

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