Early Detection and Prevention of Health Complications in Premature Infants - Early Detection of Developmental Abnormalities of Preterm Infants at 5 Years of Age
| Registry | NCT07391527 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, screening |
| Enrollment | 210 (Estimated) |
| Sponsor | Institute of Health Information and Statistics of the Czech Republic (Other gov); collaborators: České Budějovice Hospital, General University Hospital, Prague, Hospital Havlickuv Brod, County Hospital Liberec, Liberec |
| Conditions | 5 Year Old Children Born Prematurely |
| Interventions | Pediatric check-up (Other) |
| Dates | start 2025-09-23, primary completion 2026-11-01 (estimated), completion 2027-02-28 (estimated), first posted 2026-02-06, last updated 2026-02-06 |
| Locations | 4 sites in Czechia |
Related Papers Related Patents Related Grants Related Experts
All trials for 5 Year Old Children Born Prematurely All trials of Pediatric check-up
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.
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 main goal of the project is establishing a methodology for the long-term monitoring of premature infants (in the area of developmental anomalies) and their evaluation at the age of 5 years.
The main objective of this activity is to validate this screening process, which will benefit 210 patients in 2 perinatal and 2 intermediate centers. The child will undergo a comprehensive pediatric examination, including basic vision, speech, and psychomotoric assessments (MABC-2 and IDS-P). If any concerns are identified, the child will be referred to an appropriate specialist. The timeliness of this check-up has significant positive impact on both the patient and their family.
The project is supported by the European Social Fund (Operational Program Employment plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22_005/0002020.
The study has been reviewed and approved by multiple local ethical committees. The listed IRB represents the lead national ethical committee overseeing the trial.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 5 year old children born prematurely | Other | Other: Pediatric check-up |
Sex: All, ages: 5 Years to 5 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| 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 |