WithdrawnPhase 2

IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn

0Started 2012-03

Plain-language summary

To determine the efficacy of iv sildenafil in term and near term infants with PPHN (persistent pulmonary hypertension of the newborn), by measuring the need for inhaled nitric oxide (iNO) or extracorporeal membrane oxygenation (ECMO) compared to a historical control group not treated with sildenafil.

Who can participate

Age range72 Hours

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Babies \< 72 hours old and at least 34 gestational weeks with PPHN or hypoxic respiratory failure associated with idiopathic PPHN, meconium aspiration, sepsis or pneumonia * Oxygenation index \>15 and \< 60 Exclusion Criteria: * Congenital anomaly * Large left to right intracardiac or ductal shunt * Already on inhaled nitric oxide

What they're measuring

Efficacy - incidence of treatment failure

Timeframe: Day 1-14

Need for inhaled nitric oxide or Extracorporeal membrane oxygenation

Timeframe: Day 1-14

Trial details

NCT IDNCT01360671

SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-04

View on ClinicalTrials.gov More Persistent Pulmonary Hypertension of the Newborn trials