Status:
TERMINATED
Study of Sildenafil to Treat Newborns With Persistent Pulmonary Hypertension
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
State University of New York at Buffalo
Conditions:
Persistent Pulmonary Hypertension
Respiratory Failure
Eligibility:
All Genders
Up to 72 years
Phase:
PHASE2
Brief 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...
Detailed Description
Term infants with respiratory failure and persistent pulmonary hypertension (PPHN) are among the most critically ill infants in the NICU, with significant mortality and morbidity reported even for inf...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01409031
Start Date
July 1 2011
End Date
October 1 2013
Last Update
February 1 2019
Active Locations (7)
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1
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
2
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
3
Anne and Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60614
4
Women's & Children's Hospital of Buffalo SUNY
Buffalo, New York, United States, 14222