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CompletedNCT06800300Iper-NeoRiskUpdated Jan 30, 2025

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

An observational study in PreTerm Neonate, Pulmonary Hypertension of Newborn and Right Ventricular Dysfunction, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Completed at 2 sites in Italy. Open to participants aged Up to 30 Days. Per ClinicalTrials.gov, last updated 2025-01-30.

Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
51
Ages
Up to 30 Days
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • PreTerm Neonate
  • Pulmonary Hypertension of Newborn
  • Right Ventricular Dysfunction
03

In context

Ventricular Dysfunction, Right

90 studies on the registry are indexed under Ventricular Dysfunction, Right; 28 are open to participants now.

This study's enrollment of 51 is below the median of 100 across 51 observational studies indexed under Ventricular Dysfunction, Right.

Browse Ventricular Dysfunction, Right studies →

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 511 studies on the registry; 287 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 30 Days
Sexes eligible
All
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.)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
51 participants (actual)
Patient registry
No
06

What researchers measure

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

    Time frame: 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.

    Echocardiographic parameters

    Time frame: From enrollment to the 1 year follow up

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06800300
Responsible party
Sponsor
First posted
Jan 30, 2025
Start date
Jun 1, 2021
Primary completion
Jun 1, 2022
Completion
Jun 1, 2023
Last update
Jan 30, 2025

Study contacts

Andrea Donti, MD
principal investigator · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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