Identification of the Risk of Remote Pulmonary Hypertension in Preterm Births. (Iper-NeoRisk)

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40138
      • IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • RM
    • Roma, RM, Italy, 00168
      • Policlinico Agostino Gemelli di Roma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Infants of gestational age (EG) ≤30 weeks, at birth and/or during neonatal follow-up afferent to the Neonatology Operating Units participating in the study (Operating Unit of Neonatology at the Policlinico Sant'Orsola Malpighi Hospital in Bologna, Italy, and the Complex Operating Unit of Neonatology at the Policlinico Agostino Gemelli Hospital in Rome, Italy.)

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify the incidence of pulmonary hypertension or right ventricular dysfunction in patients born prematurely at a 1-year follow-up.	Identify the prevalence of pulmonary hypertension and right ventricular dysfunction in patients born prematurely	From enrollment to the 1 year follow up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Andrea Donti, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Respiratory Tract Diseases; Lung Diseases; Premature Birth; Hypertension; Hypertension, Pulmonary; Ventricular Dysfunction; Ventricular Dysfunction, Right
• Other Study ID Numbers: Iper-NeoRisk

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No