A Phase 2 interventional study of Intravenous Sildenafil and Placebo in Persistent Pulmonary Hypertension and Respiratory Failure, sponsored by University of Colorado, Denver. Terminated at 7 sites in United States. Open to participants aged Up to 72 Hours. Per ClinicalTrials.gov, last updated 2019-02-01.
Sponsored by University of Colorado, Denver · Phase 2, Interventional, and Treatment
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.
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 infants with moderate disease. Currently, management is largely supportive, and includes oxygen, mechanical ventilation (conventional or high frequency ventilation), and exogenous surfactant therapy. Inhaled nitric oxide (iNO) is a pulmonary vasodilator that was approved for the treatment of hypoxic respiratory failure (HRF) and PPHN of the newborn in 1999 based on clinical trials showing a reduction in the need for rescue treatment with extracorporeal membrane oxygenation (ECMO).
One promising therapy to decrease pulmonary arterial pressure and improve oxygenation is sildenafil. Sildenafil is a cGMP-specific phosphodiesterase inhibitor that causes relatively selective pulmonary vasodilation. The use of intravenous (IV) sildenafil was recently FDA approved for use in adults in PPHN. A pilot trial studying dose response and pharmacokinetics in 36 term newborns with PPHN found that IV sildenafil was well tolerated and has the potential to induce marked improvements in oxygenation. The data from this pilot trial provided background to support the dosing regimen for this Phase II trial. We hypothesize that IV sildenafil will acutely reduce pulmonary artery pressure and improve oxygenation in near-term and term infants with PPHN, thus reducing the need for rescue therapy iNO and/or ECMO.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 3 is below the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
PPHN or hypoxemic respiratory failure associated with:
Exclusion Criteria:
Receipt of any prohibited concurrent medication:
Drug: Intravenous Sildenafil
0.4 mg/kg bolus, followed by a continuous infusion of 1.6 mg/kg/day or an equivalent volume of placebo (D5W); infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.
Other: Placebo
0.4 mg/kg bolus, followed by a continuous infusion of 1.6 mg/kg/day or an equivalent volume of placebo (D5W); infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.
Also known as: Revatio
An equivalent volume of placebo (D5W)infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.
Improvement in Oxygenation
Time frame: From baseline values at 4 and 24 hours
Receipt of Standard Therapy at Any Point During the 7-day Treatment Period
Receipt of standard therapy (inhaled nitric oxide \[iNO\] and/or extracorporeal membrane oxygenation \[ECMO\]) at any point during the 7-day treatment period
Time frame: 7-day treatment period
Change in Pulmonary Arterial Pressure
Change in pulmonary arterial pressure as calculated by echocardiography
Time frame: Baseline and 4 hours post study drug administration
Duration of Supplemental O2
Time frame: Participants will be on supplemental O2 an average of 2 weeks
Age at Hospital Discharge
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Duration of Mechanical Ventilation
Time frame: Participants will be on mechanical ventilation an average of 1 week
This trial was terminated early due to lack of recruitment.
| Milestone | Intravenous Sildenafil | Placebo |
|---|---|---|
| Started | 1 | 2 |
| Completed | 0 | 2 |
| Not completed | 1 | 0 |
| Withdrew: Transferred to other hosp | 1 | 0 |
No measurements were reported for this outcome.
Receipt of standard therapy (inhaled nitric oxide \[iNO\] and/or extracorporeal membrane oxygenation \[ECMO\]) at any point during the 7-day treatment period
No measurements were reported for this outcome.
Change in pulmonary arterial pressure as calculated by echocardiography
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intravenous Sildenafil | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Placebo | 0/2 (0%) | 1/2 (50%) | 0/2 (0%) |
| Event | Intravenous Sildenafil | Placebo |
|---|---|---|
| PaO2 < 40Respiratory, thoracic and mediastinal disorders | 0/1 | 1/2 |
Newborns meeting entry criteria
| Age, Customized(participants) | Intravenous Sildenafil | Placebo | Total |
|---|---|---|---|
| <=1 days old | 1 | 2 | 3 |
| Sex: Female, Male(Participants) | Intravenous Sildenafil | Placebo | Total |
|---|---|---|---|
| Female | 0 | 2 | 2 |
| Male | 1 | 0 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Intravenous Sildenafil | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 0 | 2 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intravenous Sildenafil | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 2 | 3 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
This study is terminated, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver