Children Born Preterm: Sustainable Health Monitoring

NCT06270368 | Recruiting

• 1 other identifier: PREHMO
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 4

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.

Conditions

Premature Birth

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• 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

Eligibility Criteria

• Age: 20 Months - 66 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants who were born and reside in the Tuscany region.

You may qualify if:

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

You may not qualify if:

• Residing outside Tuscany region

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead
• IRCCS Fondazione Stella Maris: collaborator

Study Sites (4)

Azienda Ospedaliero-Universitaria Careggi (AOUC)

Florence, Italy

RECRUITING

Meyer Children's Hospital IRCCS

Florence, Italy

RECRUITING

Azienda Ospedaliero Universitaria Pisana (AOUP)

Pisa, Italy

RECRUITING

Azienda Ospedaliero Universitaria Senese (AOUS)

Siena, Italy

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Vieri Lastrucci, MD

  Meyer Children's Hospital IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vieri Lastrucci

CONTACT

+393297487648; vieri.lastrucci@meyer.it

Elettra Berti

CONTACT

elettra.berti@meyer.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 21, 2024
• Study Start: August 5, 2020
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

IT (4)