Trial · NCT05201144
A Trial of Phosphodiesterase-5 Inhibitor in Neonatal Congenital Diaphragmatic Hernia (TOP-CDH)
NCT05201144, Phase 2, Recruiting, University of Utah
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial of Phosphodiesterase-5 Inhibitor in Neonatal Congenital Diaphragmatic Hernia (TOP-CDH). Trials, record NCT05201144. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05201144
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of Phosphodiesterase-5 Inhibitor in Neonatal Congenital Diaphragmatic Hernia (TOP-CDH)
- NCT number
- NCT05201144
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 40 participants, estimated
- Lead sponsor
- University of Utah
- Conditions
- Congenital Diaphragmatic Hernia, Pulmonary Hypertension
- Interventions
- Sildenafil Oral Suspension, Placebo
- First posted
- 2022-01-21
- Last updated
- 2025-04-04
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Secondary | Compare incidence of extracorporeal membrane oxygenation support (ECMO) between study and placebo groups | 14 days | number of infants who required ECMO during the study treatment period will be compared between study and placebo groups |
| Secondary | Compare incidence of death between study and placebo groups | 14 days | number of infants who died during the study treatment period will be compared between study and placebo groups |
| Secondary | Compare use of additional pulmonary vasodilators between study and placebo groups | 14 days | Any pulmonary vasodilator (eg; inhaled nitric oxide, milrinone, etc) that is started after first study drug dose through 14 days will be counted and compared between study groups |
| Secondary | Compare new onset hypotension between study and placebo groups | 4 hours | Number of infants experiencing new onset of systemic hypotension within 4 hours of study drug initiation, as defined by a greater than 20% decrease in mean arterial blood pressure from baseline value despite additional volume support up to 20 mL/kg and/or an increase in inotropic use will be compared between study and placebo groups |
| Secondary | Compare new onset of oliguria between study and placebo groups | 36 hours | Number of infants experiencing new oliguria of \< 1mL/kg/h for 12 hours unresponsive to fluid administration with onset within the first 36 hours of study drug |
| Other | Compare incidence of open-label sildenafil use during/after study period between study and placebo groups | 3 months | Number of infants who receive open-label sildenafil during study period (protocol violation, but may happen due to clinical illness) or after study period through discharge will be compared between the study groups |
| Other | Compare number of ventilator days between study and placebo group | 14 days | Each calendar day in which the infant is intubated and on a ventilator will be counted from day of first study drug dose through day of last study drug dose |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05201144
GET https://conductscience.org/api/trials/v1/NCT05201144/registered