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NCT06270368 Clinical Trial

Children Born Preterm: Sustainable Health Monitoring

Premature Birth Clinical Trial

Official title:
Children Born Preterm: Sustainable Health Monitoring

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06270368
Other study ID # PREHMO
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 5, 2020
Est. completion date December 31, 2025

Study information
Verified date February 2024
Source Meyer Children's Hospital IRCCS
Contact Vieri Lastrucci
Phone +393297487648
Email vieri.lastrucci@meyer.it
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 650
Est. completion date December 31, 2025
Est. primary completion date August 31, 2025
Accepts healthy volunteers
Gender All
Age group 20 Months to 66 Months
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Azienda Ospedaliero-Universitaria Careggi (AOUC) Firenze
Italy Meyer Children's Hospital IRCCS Firenze
Italy Azienda Ospedaliero Universitaria Pisana (AOUP) Pisa
Italy Azienda Ospedaliero Universitaria Senese (AOUS) Siena

Sponsors (2)
Lead Sponsor Collaborator
Meyer Children's Hospital IRCCS IRCCS Fondazione Stella Maris

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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). The measurements will be assessed at 20-28 months of age
Primary 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). The measurements will be assessed at 56-66 months of age
Secondary Presence of visual or hearing impairement The measurements will be assessed at 20-28 months of age and at 56-66 months of age
Secondary Presence of asthma The measurements will be assessed at 56-66 months of age
Secondary Access to care Hospitalizations and surgeries occurred in the last 12 months The measurements will be assessed at 20-28 months of age and at 56-66 months of age
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