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Identification of the Risk of Remote Pulmonary Hypertension in Preterm Births.

Identification of the Risk of Remote Pulmonary Hypertension in Preterm Births.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06800300
Acronym
Iper-NeoRisk
Enrollment
51
Registered
2025-01-30
Start date
2021-06-01
Completion date
2023-06-01
Last updated
2025-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PreTerm Neonate, Pulmonary Hypertension of Newborn, Right Ventricular Dysfunction

Brief summary

This study aims to learn about the prevalence of pulmonary hypertension and right ventricular dysfunction in patients born prematurely, at birth and at a distance, and the association with the development of pulmonary bronchodysplasia, so that screening programs can be set up in the future and proper treatment can be initiated in a timely manner.

Detailed description

This study aims to learn about the prevalence of pulmonary hypertension and right ventricular dysfunction in patients born prematurely, at birth and at a distance, and the association with the development of pulmonary bronchodysplasia, so that screening programs can be set up in the future and proper treatment can be initiated in a timely manner. Enrolled patients, should asymptomatic pulmonary hypertension be diagnosed, will be able to be taken to dedicated outpatient clinics and initiate appropriate treatment if indicated. The primary goal of this study is to evaluate the incidence of late pulmonary arterial hypertension and/or right ventricular dysfunction in a cohort of former preterm patients. The study will also provide a greater awareness of the epidemiology of pulmonary hypertension and right ventricular dysfunction in these patients and allow appropriate screening and follow-up to be planned.

Interventions

None listed

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
No minimum to 30 Days
Healthy volunteers
No

Inclusion criteria

* Patients diagnosed with prematurity with gestational age less than 30 weeks evaluated at outpatient clinics dedicated to neonatal follow-up of participating health care providers during the study data collection period. * Obtaining informed consent.

Exclusion criteria

* Prenatal or postnatal diagnosis of genetic disease; * Concomitant presence of congenital heart disease except interatrial defect or patency of the ductus arteriosus; * Concomitant presence of diaphragmatic hernia

Design outcomes

Primary

MeasureTime frameDescription
Identify the incidence of pulmonary hypertension or right ventricular dysfunction in patients born prematurely at a 1-year follow-up.From enrollment to the 1 year follow upIdentify the prevalence of pulmonary hypertension and right ventricular dysfunction in patients born prematurely

Secondary

MeasureTime frameDescription
to define risk classes for the development of pulmonary arterial hypertension in patients born prematurely.From enrollment to the 1 year follow upEchocardiographic parameters

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026