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

Completed

• Conditions: PreTerm Neonate; Pulmonary Hypertension of Newborn; Right Ventricular Dysfunction

• Registration Number: NCT06800300
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2022-06-01
• Study Completion: 2023-06-01
• Status Verified: 2024-12
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Study First Posted: 2025-01-30
• Last Update Posted: 2025-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 up	Identify the prevalence of pulmonary hypertension and right ventricular dysfunction in patients born prematurely

Secondary Outcome Measures

Name	Time	Method
to define risk classes for the development of pulmonary arterial hypertension in patients born prematurely.	From enrollment to the 1 year follow up	Echocardiographic parameters

Trial Locations

Locations (2)

Policlinico Agostino Gemelli di Roma; 🇮🇹 Roma, RM, Italy

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, BO, Italy