PreTerm NeonateIper-NeoRiskNCT06800300
Identification of the Risk of Remote Pulmonary Hypertension in Preterm Births.
An observational study of PreTerm Neonate and Pulmonary Hypertension of Newborn, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 30 days
- Conditions the study is for
- PreTerm Neonate, Pulmonary Hypertension of Newborn, Right Ventricular Dysfunction
- How many people
- 51 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jun 2021to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 days
- All sexes
- No healthy volunteers
- Child
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.)
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, BO, 40138
Policlinico Agostino Gemelli di Roma
Roma, RM, 00168
About this study
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.
- Medical subject headings
- Ventricular Dysfunction, Right
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From enrollment to the 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Jun 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreTerm NeonateStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Donti, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800300
- Sponsor's protocol ID
- Iper-NeoRisk
- Acronym
- Iper-NeoRisk
- Status last verified
- Dec 2024
- First submitted
- 9 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Risk of Remote Pulmonary Hypertension in Preterm Births.
- ClinicalTrials.gov ID
- NCT06800300
- Acronym / sponsor ID
- Iper-NeoRisk / Iper-NeoRisk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.)
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identify the incidence of pulmonary hypertension or right ventricular dysfunction in patients born prematurely at a 1-year follow-up.
Time frame: From enrollment to the 1 year follow up
Identify the prevalence of pulmonary hypertension and right ventricular dysfunction in patients born prematurely
1 secondary outcome
to define risk classes for the development of pulmonary arterial hypertension in patients born prematurely.
Time frame: From enrollment to the 1 year follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Donti, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PreTerm Neonate and Pulmonary Hypertension of Newborn, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify the incidence of pulmonary hypertension or right ventricular dysfunction in patients born prematurely at a 1-year follow-up. (time frame: From enrollment to the 1 year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.