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Children Born Preterm: Sustainable Health Monitoring

NCT ID: NCT06270368

Last Updated: 2024-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

650 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-05

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Premature Birth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Children born preterm (gestational age below 37 weeks at birth) in Tuscany Region
* Acquisition of the informed consent

Exclusion Criteria

* Residing outside Tuscany region
Minimum Eligible Age

20 Months

Maximum Eligible Age

66 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Fondazione Stella Maris

OTHER

Sponsor Role collaborator

Meyer Children's Hospital IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Vieri Lastrucci

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vieri Lastrucci, MD

Role: PRINCIPAL_INVESTIGATOR

Meyer Children's Hospital IRCCS

Locations

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Azienda Ospedaliero-Universitaria Careggi (AOUC)

Florence, , Italy

Site Status RECRUITING

Meyer Children's Hospital IRCCS

Florence, , Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria Pisana (AOUP)

Pisa, , Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria Senese (AOUS)

Siena, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Vieri Lastrucci

Role: CONTACT

[email protected]
+393297487648

Elettra Berti

Role: CONTACT

[email protected]

Facility Contacts

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Simone Pratesi

Role: primary

Vieri Lastrucci

Role: primary

[email protected]

Rosa Scaramuzzo

Role: primary

Carlo Valerio Bellieni

Role: primary

Other Identifiers

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PREHMO

Identifier Type: -

Identifier Source: org_study_id

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