Children Born Preterm: Sustainable Health Monitoring

February 20, 2024 updated by: Vieri Lastrucci, Meyer Children's Hospital IRCCS
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Firenze, Italy
        • Recruiting
        • Azienda Ospedaliero-Universitaria Careggi (AOUC)
        • Contact:
          • Simone Pratesi
      • Firenze, Italy
      • Pisa, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana (AOUP)
        • Contact:
          • Rosa Scaramuzzo
      • Siena, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Senese (AOUS)
        • Contact:
          • Carlo Valerio Bellieni

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
The measurements will be assessed at 20-28 months of age
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).
The measurements will be assessed at 56-66 months of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of visual or hearing impairement
Time Frame: The measurements will be assessed at 20-28 months of age and at 56-66 months of age
The measurements will be assessed at 20-28 months of age and at 56-66 months of age
Presence of asthma
Time Frame: The measurements will be assessed at 56-66 months of age
The measurements will be assessed at 56-66 months of age
Access to care
Time Frame: 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
The measurements will be assessed at 20-28 months of age and at 56-66 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meyer Children's Hospital IRCCS

Collaborators

IRCCS Fondazione Stella Maris

Investigators

  • Principal Investigator: Vieri Lastrucci, MD, Meyer Children's Hospital IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2020

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

February 20, 2024

First Posted (Estimated)

February 21, 2024

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREHMO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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