Children Born Preterm: Sustainable Health Monitoring
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Premature Birth
- Sponsor
- Meyer Children's Hospital IRCCS
- Enrollment
- 650
- Locations
- 4
- Primary Endpoint
- Childhood development
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Vieri Lastrucci
MD
Meyer Children's Hospital IRCCS
Eligibility Criteria
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
Outcomes
Primary Outcomes
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).
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).
Secondary Outcomes
- 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)