Children Born Preterm: Sustainable Health Monitoring

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06270368

Enrollment

650

Registered

2024-02-21

Start date

2020-08-05

Completion date

2025-12-31

Last updated

2024-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Months to 66 Months

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

Design outcomes

Primary

Measure	Time frame	Description
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).
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).

Secondary

Measure	Time frame	Description
Presence of visual or hearing impairement	The measurements will be assessed at 20-28 months of age and at 56-66 months of age	—
Presence of asthma	The measurements will be assessed 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

Countries

Italy

Contacts

Primary ContactVieri Lastrucci

vieri.lastrucci@meyer.it+393297487648

Backup ContactElettra Berti

elettra.berti@meyer.it

Outcome results