Clinical trial Recruiting at 4 sites Interventional Ages 5 to 5

Early detection of developmental problems in five-year-old children born prematurely

Official title: Early Detection and Prevention of Health Complications in Premature Infants - Early Detection of Developmental Abnormalities of Preterm Infants at 5 Years of Age

Run by Institute of Health Information and Statistics of the Czech Republic · NCT07391527 · Data updated 2026-11-12

This project will test a one-time screening visit for five-year-old children born before 37 weeks to spot vision, speech, and motor development problems early and refer them for care if needed.

Quick facts

Study typeInterventional
Ages5 Years to 5 Years
SexAll
Enrollment210 (estimated)
SponsorInstitute of Health Information and Statistics of the Czech Republic
Government
Locations4 sites (České Budějovice, Czech Republic and 3 other locations)
StatusRecruiting
StartedSeptember 23, 2025
Main results expectedFebruary 2027
Study endsAugust 2027
Registry record updatedNovember 3, 2026
Trial IDNCT07391527 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Five-year-old children born before 37 weeks gestation who live in a Czech-speaking environment, have parents with Czech citizenship, and whose parents provide signed consent are eligible.

Probably not a fit

Children with severe psychomotor retardation or severe congenital malformations, those without parental consent, or those who are not Czech-speaking or lack Czech-citizen parentage are not likely to benefit from this screening program.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a national, prospective, multicenter pilot that will enroll about 210 five-year-old children who were born prematurely at selected Czech centers. Each child will receive a comprehensive pediatric check-up including basic vision and speech screening and standardized psychomotor testing (MABC-2 and IDS-P). Data will be used to validate a screening workflow and to develop a proposal for a national long-term monitoring methodology for children born preterm. Children with identified concerns will be referred to appropriate specialists for follow-up.

Why it matters

Potential benefit: If successful, the project could enable earlier detection and timely referral for developmental, visual, or speech problems, reducing delays and family burden.

How similar studies have gone: Longitudinal neonatal follow-up programs and early developmental screening have previously shown value in earlier detection and referral, but this specific national pilot to validate a Czech methodology is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* Unsigned consent for participation in the project and consent for the processing of personal data.
* Severe psychomotor retardation .
* Severe congenital malformations.

Where it's running

  • České Budějovice Hospital
    České Budějovice, Czech Republic, Czechia
    Recruiting
  • Hospital Havlíčkův Brod
    Havlíčkův Brod, Czech Republic, Czechia
    Recruiting
  • County Hospital Liberec
    Liberec, Czech Republic, Czechia
    Recruiting
  • General University Hospital
    Prague, Czech Republic, Czechia
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.