Study of Sildenafil to Treat Newborns With Persistent Pulmonary Hypertension

• Status: Terminated
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborators: Ann & Robert H Lurie Children's Hospital of Chicago; National Heart, Lung, and Blood Institute (NHLBI); State University of New York at Buffalo; University of Alabama at Birmingham; University of Utah; Vanderbilt University
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

• 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 12as 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

Exclusion Criteria:

• 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.