Clinical trial NCT06800300: Identification of the Risk of Remote Pulmonary Hypertension in Preterm Births.
Official title: Identification of the Risk of Remote Pulmonary Hypertension in Preterm Births.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PreTerm Neonate
Pulmonary Hypertension of Newborn
Right Ventricular Dysfunction
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 51
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Identify the incidence of pulmonary hypertension or right ventricular dysfunction in patients born prematurely at a 1-year follow-up.
timeFrame: From enrollment to the 1 year follow up
Secondary outcomes:
measure: to define risk classes for the development of pulmonary arterial hypertension in patients born prematurely.
timeFrame: From enrollment to the 1 year follow up
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
state: BO
city: Roma
country: Italy
facility: Policlinico Agostino Gemelli di Roma
state: RM
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Andrea Donti, MD
role: PRINCIPAL_INVESTIGATOR
References: