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Phosphodiesterase-5 Inhibitor

Sildenafil for Diaphragmatic Hernia

Phase 2
Recruiting
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

This trial is investigating the safety and effectiveness of sildenafil therapy for PH in neonates with CDH.

Who is the study for?
This trial is for newborns with a birth defect called congenital diaphragmatic hernia (CDH) who are in the NICU at Primary Children's Hospital. They must have had surgery to repair the hernia and show signs of pulmonary hypertension on an echocardiogram taken within 48-72 hours after surgery. Babies can't join if they didn't have surgery, need ECMO, or are allergic to sildenafil.
What is being tested?
The study tests whether Sildenafil Oral Suspension, a drug that relaxes blood vessels in the lungs and is used off-label for neonatal pulmonary hypertension, is safe and effective for babies with CDH post-surgery. Some infants will receive this medication while others will get a placebo to compare outcomes.
What are the potential side effects?
Sildenafil may cause side effects like low blood pressure, bleeding issues, seizures in extreme cases, or vision problems. However, its safety profile in newborns specifically needs more research which this trial aims to provide.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Echocardiography
Secondary study objectives
Compare incidence of death between study and placebo groups
Extracorporeal Membrane Oxygenation
Compare new onset hypotension between study and placebo groups
+2 more
Other study objectives
Compare incidence of open-label sildenafil use during/after study period between study and placebo groups
Compare number of ventilator days between study and placebo group

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Sildenafil citrateActive Control1 Intervention
Sildenafil citrate 1mg/kg every 8 hours (PO or NG) for up to 14 days
Group II: PlaceboPlacebo Group1 Intervention
Equivalent volume of Ora-sweet©/Ora-plus© every 8 hours (PO or NG) for up to 14 days

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,139 Previous Clinical Trials
1,697,320 Total Patients Enrolled
~4 spots leftby Mar 2025
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