Premature BirthNCT06270368
Children Born Preterm: Sustainable Health Monitoring
An observational study of Premature Birth, run by Meyer Children's Hospital IRCCS at 4 sites in Italy.
Trial summary
Children born preterm are recognized to be at higher risk of short and long term complications and a formal follow-up of infants and children born preterm is recommended by international and national scientific societies. Read more about this study
- Who is it for?
- Ages 20 to 66 months
- Conditions the study is for
- Premature Birth
- How many people
- 650 participants
- Where
- 4 sitesItaly
- Study dates
- 5 Aug 2020to 31 Dec 2025
- 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 20 to 66 months
- All sexes
- Child
Study population: Preterm infants who were born and reside in the Tuscany region.
Who may be able to join
- Children born preterm (gestational age below 37 weeks at birth) in Tuscany Region
- Acquisition of the informed consent
Who cannot join
- Residing outside Tuscany region
Trial locations and contacts
4 sites in 1 country.
Elettra Berti contact
Italy4 sites, 4 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria Careggi (AOUC)
Florence
Simone Pratesi
- Recruiting
Meyer Children's Hospital IRCCS
Florence
Vieri Lastrucci, vieri.lastrucci@meyer.it
- Recruiting
Azienda Ospedaliero Universitaria Pisana (AOUP)
Pisa
Rosa Scaramuzzo
- Recruiting
Azienda Ospedaliero Universitaria Senese (AOUS)
Siena
Carlo Valerio Bellieni
About this study
Children born preterm are recognized to be at higher risk of short and long term complications and a formal follow-up of infants and children born preterm is recommended by international and national scientific societies. However, in Italy as well as in Tuscany, such a follow up is not usually done, and data are not collected in a structured way. The goal of this observational study is to evaluate the association between a large number of early life exposures and health outcomes and access to care during childhood in infants born preterm. The main questions it aims to answer are: • what is the role of prenatal and perinatal factors in influencing health outcomes during childhood in preterm infants? • What is the role of prenatal and perinatal factors in influencing access to care during childhood? Participants will be asked to attend a follow-up visit for the purpose of collecting health data.
- Conditions
- Premature Birth
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant development
Infant development comprises physical, cognitive, social-emotional, linguistic, and behavioral milestones. Infant development is assessed with the Bayley Scales Of Infant and Toddler Development third edition (Bayley - III).
Measured: The measurements will be assessed at 20-28 months of age
Childhood development
Childhood development comprises physical, cognitive, social-emotional, linguistic, and behavioral milestones. Childhood development is assessed with the Ages and Stages Questionnaires (ASQ-3).
Measured: The measurements will be assessed at 56-66 months of age
Secondary outcomes (3)
Presence of visual or hearing impairement
Measured: The measurements will be assessed at 20-28 months of age and at 56-66 months of age
Presence of asthma
Measured: The measurements will be assessed at 56-66 months of age
Access to care
Hospitalizations and surgeries occurred in the last 12 months
Measured: The measurements will be assessed at 20-28 months of age and at 56-66 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start5 Aug 2020
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Fondazione Stella Maris
- Responsible party
- Principal investigator, Vieri Lastrucci, Meyer Children's Hospital IRCCS
- Investigators
- Vieri Lastrucci, MD, Principal investigator, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270368
- Sponsor's protocol ID
- PREHMO
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 21 Feb 2024
- 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 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children Born Preterm: Sustainable Health Monitoring
- ClinicalTrials.gov ID
- NCT06270368
- Acronym / sponsor ID
- PREHMO
- Conditions
- Premature Birth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Collaborators
- IRCCS Fondazione Stella Maris
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Feb 2024 (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.
Children born preterm are recognized to be at higher risk of short and long term complications and a formal follow-up of infants and children born preterm is recommended by international and national scientific societies. However, in Italy as well as in Tuscany, such a follow up is not usually done, and data are not collected in a structured way. The goal of this observational study is to evaluate the association between a large number of early life exposures and health outcomes and access to care during childhood in infants born preterm. The main questions it aims to answer are: • what is the role of prenatal and perinatal factors in influencing health outcomes during childhood in preterm infants? • What is the role of prenatal and perinatal factors in influencing access to care during childhood? Participants will be asked to attend a follow-up visit for the purpose of collecting health data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 66 months
- Sex
- All
- Age groups
- Child
- Study population
- Preterm infants who were born and reside in the Tuscany region.
Key inclusion criteria (2 listed)
- Children born preterm (gestational age below 37 weeks at birth) in Tuscany Region
- Acquisition of the informed consent
Key exclusion criteria (1 listed)
- Residing outside Tuscany region
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
Infant development
Time frame: The measurements will be assessed at 20-28 months of age
Infant development comprises physical, cognitive, social-emotional, linguistic, and behavioral milestones. Infant development is assessed with the Bayley Scales Of Infant and Toddler Development third edition (Bayley - III).
Childhood development
Time frame: The measurements will be assessed at 56-66 months of age
Childhood development comprises physical, cognitive, social-emotional, linguistic, and behavioral milestones. Childhood development is assessed with the Ages and Stages Questionnaires (ASQ-3).
3 secondary outcomes
Presence of visual or hearing impairement
Time frame: The measurements will be assessed at 20-28 months of age and at 56-66 months of age
Presence of asthma
Time frame: The measurements will be assessed at 56-66 months of age
Access to care
Time frame: The measurements will be assessed at 20-28 months of age and at 56-66 months of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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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.
Elettra Berti contact
Vieri Lastrucci, MD principal investigator
Meyer Children's Hospital IRCCS
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth, run by Meyer Children's Hospital IRCCS at 4 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 1 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: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vieri Lastrucci (+393297487648, vieri.lastrucci@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant development (time frame: The measurements will be assessed at 20-28 months of age). The study lists 2 primary outcomes in all. 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 21 Feb 2024.