Study of Sildenafil to Treat Newborns With Persistent Pulmonary Hypertension

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Persistent Pulmonary Hypertension, Respiratory Failure

In brief

The purpose of this study is to determine whether intravenous sildenafil reduces pulmonary artery pressure and improves oxygenation in near-term and term infants with persistent pulmonary hypertension.

Key facts

Study ID

NCT01409031

Run by

University of Colorado, Denver

People needed

3

Starts

2011-07-01

Expected to finish

2013-10-01

Last updated by the study team

2019-02-01

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent from legally acceptable guardian
• PPHN or hypoxemic respiratory failure associated with:
• Idiopathic PPHN
• Meconium aspiration syndrome
• Respiratory distress syndrome
• Sepsis
• Pneumonia
• Greater than or equal to 35 weeks gestation
• Age at enrollment less than 72 hours
• Moderate hypoxemic respiratory failure, with 12<OI<35 (oxygenation index, calculated as FiO2 * mean airway pressure * 100 / postductal PaO2)
• Absence of structural heart disease (except patent ductus arteriosus, atrial septal defect <1cm, or muscular ventricular septal defect < 2mm)
• Absence of lethal congenital anomaly
• Not participating in another concurrent experimental study

You may not qualify if…

• Prior or immediate need for iNO or ECMO
• Profound hypoxemia: qualifying PaO2 <30 mmHg, from a blood gas drawn within 30 minutes of starting study drug infusion.
• Hypotension: Mean arterial pressure <35 mmHg
• Congenital heart disease, except patent ductus arteriosus, atrial septal defect <1cm, or muscular ventricular septal defect <2mm
• Congenital diaphragmatic hernia or lung hypoplasia syndromes, diagnosed on the basis of prolonged oligohydramnios
• Active seizures
• Apgar score of <3 at 5 minutes
• Bleeding diathesis
• Receipt of any other experimental drug or device
• Receipt of any prohibited concurrent medication:
• Potent cytochrome P450 3A4 inhibitors (e.g., erythromycin, ketoconazole, itraconazole and protease inhibitors)
• Endothelin antagonists (e.g. Tracleer/bosentan)
• Intravenous nitrates or nitric oxide donors
• Known hereditary degenerative retinal disorders such as retinitis pigmentosa.
• In the opinion of the investigator, a subject who is not likely to complete the study or would be considered inappropriate for the study, for any reason.

Where it is running

• University of Colorado Health Sciences Center — Aurora, Colorado, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Anne and Robert H Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Women's & Children's Hospital of Buffalo SUNY — Buffalo, New York, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Primary Children's Medical Center, Utah — Salt Lake City, Utah, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.