Early Detection of Developmental Abnormalities of Preterm Infants at 5 Years of Age

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-5
SponsorInstitute of Health Information and Statistics of the Czech Republic

About this trial

The project is a national, prospective, multicenter, interventional pilot project focused on the follow up of 5 year old children that were born prematurely.

The primary aim of the project is to prepare, test, and develop a proposal for a national methodology for the care of children born prematurely. This will minimize the negative impacts on the overall development of the child and the family of the prematurely born children.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed consent for participation in the project and consent for the processing of personal data.

Children born before 37 weeks of gestation, aged 5 years, growing up in a Czech-speaking environment.

To ensure valid linkage of all data sources, the children must have been born to parents with Czech citizenship.

Disqualifiers

Unsigned consent for participation in the project and consent for the processing of personal data.

Severe psychomotor retardation .

Severe congenital malformations.

Trial design

Design model

Single group

Treatments tested in this trial

  • Pediatric check-up

    Other intervention

    Eligible children are invited to undergo a comprehensive pediatric evaluation, including vision screening (Plusoptix) and speech and language tests (TEPO - sentence comprehension, TEPRO - vocabulary production). Subsequently, children are referred for psychological (IDS-P), motor (MABC-2), and pulmonary (spirometry) assessments. If any deviations are identified, the child is referred to appropriate specialists (e.g., rehabilitation physician, speech therapist, psychiatrist, ophthalmologist).

Treatment groups

210 Participants
are divided into 1 treatment group
Group A: 5 year old children born prematurelyOther 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of premature infants with identified pathology at 5 years (overall, by detected pathology)

Time frame
During study participation (up to 3 days)
2

Proportion of premature infants referred to a specialized center (overall, by detected pathology)

Time frame
During study participation (up to 3 days)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Health Information and Statistics of the Czech Republic

Lead sponsor

České Budějovice Hospital

Collaborator

General University Hospital, Prague

Collaborator

Hospital Havlickuv Brod

Collaborator

County Hospital Liberec, Liberec

Collaborator