Early Detection of Developmental Abnormalities of Preterm Infants at 5 Years of Age
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pediatric check-up.
- Who it may be relevant to
- Registry conditions: 5 Year Old Children Born Prematurely. Basic parameters: 5 years — 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Detailed description
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.
Interventions
- Other Pediatric check-up
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).
Primary outcome measures
- Proportion of premature infants with identified pathology at 5 years (overall, by detected pathology) [Time frame: During study participation (up to 3 days)]
- Proportion of premature infants referred to a specialized center (overall, by detected pathology) [Time frame: During study participation (up to 3 days)]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Czechia · 4 centers
- České Budějovice Hospital — České Budějovice
- Hospital Havlíčkův Brod — Havlíčkův Brod
- County Hospital Liberec — Liberec
- General University Hospital — Prague
Identifiers
NCT: NCT07391527 · UZIS 2025/3