Children Born Preterm: Sustainable Health Monitoring

Recruiting

• Conditions: Premature Birth

• Registration Number: NCT06270368
• Lead Sponsor: Meyer Children's Hospital IRCCS

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-05
• Status Verified: 2024-02
• Study First Submitted: 2024-02-12
• Study First Submitted QC: 2024-02-20
• Last Update Submitted: 2024-02-20
• Study First Posted: 2024-02-21
• Last Update Posted: 2024-02-21
• Primary Completion: 2025-08-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 650

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Childhood development	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).
Infant development	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).

Secondary Outcome Measures

Name	Time	Method
Presence of asthma	The measurements will be assessed at 56-66 months of age
Presence of visual or hearing impairement	The measurements will be assessed at 20-28 months of age and at 56-66 months of age
Access to care	The measurements will be assessed at 20-28 months of age and at 56-66 months of age	Hospitalizations and surgeries occurred in the last 12 months

Trial Locations

Locations (4)

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, Italy