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Phosphodiesterase-5 Inhibitor

Sildenafil citrate for Pulmonary Hypertension

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Echocardiography

Secondary outcome measures

Compare incidence of death between study and placebo groups

Extracorporeal Membrane Oxygenation

Compare new onset hypotension between study and placebo groups

+2 more

Other outcome measures

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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,103 Previous Clinical Trials

1,781,677 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being included in this research project?

"Affirmative. According to the details posted on clinicaltrials.gov, this medical research is actively enrolling patients since September 15th 2022 and was last updated 27 days later. The trial seeks 40 participants from one specified location."

Answered by AI

Has the Food and Drug Administration green-lighted Sildenafil citrate?

"There is some evidence of Sildenafil citrate's safety, so it has been assigned a value of 2 on the scale. However, as this clinical trial is in Phase 2 there are no findings that demonstrate efficacy yet."

Answered by AI

Is this research endeavor actively searching for participants?

"This clinical experiment is presently looking for study participants, with the original post date being on September 15th 2022 and last update taking place on September 27th of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial of Phosphodiesterase-5 Inhibitor in Neonatal Congenital Diaphragmatic Hernia (TOP-CDH)

Michelle Yang 2022. "A Trial of Phosphodiesterase-5 Inhibitor in Neonatal Congenital Diaphragmatic Hernia (TOP-CDH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05201144.

All > Pulmonary Hypertension > Hernia