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Pulmonary Hypertension, Familial Persistent, of the Newborn | A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn

Pulmonary Hypertension, Familial Persistent, of the Newborn research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pulmonary Hypertension, Familial Persistent, of the Newborn

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:placeboIV placebo or 0.9% sodium chloride or 10% dextrose. Infusion rate based on weight.

Drug:iv sildenafilloading dose of 0.1 mg/kg over 30 minutes followed by maintenance dose of 0.03 mg/kg/h. To infuse minimum 48 hours and maximum of 14 days.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

placeboiv placebo of normal saline or 10% dextrose

sildenafilActive study drug

Study Status

Recruiting

Start Date: August 2013

Completed Date: August 2020

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Time on inhaled nitric oxide treatment after initiation of iv study drug

Secondary Outcome: Time to final weaning of mechanical ventilation for persistent pulmonary hypertension of the newborn

Study sponsors, principal investigator, and references

Principal Investigator: Pfizer CT.gov Call Center

Lead Sponsor: Pfizer

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01720524

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