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Completed

NCT Number: NCT06800300

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

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.

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Key information

Age range

Up to 30 day

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, BO, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Identify the incidence of pulmonary hypertension or right ventricular dysfunction in patients born prematurely at a 1-year follow-up.

    Time frame: From enrollment to the 1 year follow up

    Identify the prevalence of pulmonary hypertension and right ventricular dysfunction in patients born prematurely

Secondary outcomes

  1. to define risk classes for the development of pulmonary arterial hypertension in patients born prematurely.

    Time frame: From enrollment to the 1 year follow up

    Echocardiographic parameters

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: Iper-NeoRisk

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 30, 2025
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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