Early detection of developmental problems in five-year-old children born prematurely
Early Detection and Prevention of Health Complications in Premature Infants - Early Detection of Developmental Abnormalities of Preterm Infants at 5 Years of Age
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 5 Years to 5 Years |
| Sex | All |
| Sponsor | Institute of Health Information and Statistics of the Czech Republic Government |
| Locations | 4 sites (České Budějovice, Czech Republic and 3 other locations) |
| Trial ID | NCT07391527 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
České Budějovice, Czech Republic and 3 other locations
- 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
- Study coordinator: Daniela Dokoupilová, MSc
- Email: daniela.dokoupilova@uzis.cz
- Phone: +420725441408
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.