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Sildenafil for Pulmonary Hypertension in Infants with Congenital Diaphragmatic Hernia

This study is looking at how well sildenafil oral suspension works for infants with congenital diaphragmatic hernia (CDH) who also have pulmonary hypertension (high blood pressure in the lungs) after surgery. CDH is a birth defect where a baby's diaphragm (the muscle that helps with breathing) doesn't form completely. Sildenafil works by relaxing blood vessels in the lungs. Researchers want to see if sildenafil can improve heart function in these babies compared to a placebo (an inactive substance). You might be able to join if your baby is admitted to PCH NICU, has CDH, has had surgery, and an echocardiogram (a heart ultrasound) shows a specific heart measurement (LVEI ≥ 1.4) within 48-72 hours after surgery. The study plans to enroll 40 infants, but its current status is unclear.

Study design
This is an interventional study comparing sildenafil oral suspension to a placebo. It plans to enroll 40 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main measurement for this study is taken 14 days after treatment begins.

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NCT05201144

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

Recruiting
PHASE2All AgesInterventionalTreatment
University of Utah
~40 participants
Updated 2025-04-04 on ClinicalTrials.gov
What's tested:Sildenafil Oral SuspensionPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Left Ventricular Eccentricity Index (LVEI) on echocardiogram after 14 days of study treatment compared to baseline echocardiogram as compared to placebo.
Measured over 14 days

Conditions

Congenital Diaphragmatic Hernia
Pulmonary Hypertension

Explore related trials

Congenital Diaphragmatic HerniaPulmonary Hypertension

Where it's being run

1 sites across 1 states
Utah1

Who to contact

Carrie A Rau, RN
[email protected]
801-213-3360
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Infants admitted to PCH NICU
Diagnosis of congenital diaphragmatic hernia (CDH)
Status post-surgical repair of diaphragmatic defect
Has an echocardiogram 48-72 hours after repair with left ventricular eccentricity index (LVEI) ≥ 1.4
Parental consent obtained within 24 hours after the above echocardiogram

Exclusion

Infants with CDH who do not undergo surgical repair
Does not have an echocardiogram 48-72 hours post-repair
Has LVEI \< 1.4 on above echocardiogram
Has concurrent severe congenital heart defect that requires neonatal cardiac repair
Has a documented sildenafil allergy
Concurrent therapy with fluconazole at time of study drug initiation
Inability to obtain parental consent within 24 hours of the echocardiogram
Receiving extracorporeal membrane oxygenation (ECMO) at the time of the study

What this trial measures

  • Change in Left Ventricular Eccentricity Index (LVEI) on echocardiogram after 14 days of study treatment compared to baseline echocardiogram as compared to placebo.14 days

    On echocardiogram, the septal position at end systole with either flattening or bowing into the left ventricle indicates elevated right ventricular pressures, a surrogate for elevated pulmonary arterial pressures and can be used to determine pulmonary hypertension (PH). LVEI has been shown to adequately quantify septal flattening when correlated to cardiac catheterization measures. Its use decreases inter-observer variability and is a reliable assessment of neonatal PH. Elevated values of LVEI ≥ 1.4 are associated with right ventricular half to suprasystemic pressures, consistent with PH. Normative values of LVEI in neonates without PH are ≤1.