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

NCT06800300 | Completed

• 1 other identifier: Iper-NeoRisk
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 2

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.

Conditions

PreTerm Neonate; Pulmonary Hypertension of Newborn; Right Ventricular Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  From enrollment to the 1 year follow up

Eligibility Criteria

• Age: Up to 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (2)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, BO, 40138, Italy

Location

Policlinico Agostino Gemelli di Roma

Roma, RM, 00168, Italy

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Right

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• Andrea Donti, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 30, 2025
• Study Start: June 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2023
• Last Updated: January 30, 2025

Record last verified: 2024-12

Locations

IT (2)