5 Year Old Children Born Prematurely
Conditions
Keywords
follow up of premature infants, early detection, developmental abnormality, Czech Republic
Brief summary
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
OTHERPediatric 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).
Sponsors
Institute of Health Information and Statistics of the Czech Republic
České Budějovice Hospital
General University Hospital, Prague
Hospital Havlickuv Brod
County Hospital Liberec, Liberec
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 5 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of premature infants with identified pathology at 5 years (overall, by detected pathology) | During study participation (up to 3 days) |
| Proportion of premature infants referred to a specialized center (overall, by detected pathology) | During study participation (up to 3 days) |
Countries
Czechia
Contacts
CONTACTDaniela Dokoupilová, MSc
CONTACTLucie Mandelová, Ph.D.
STUDY_DIRECTORDaniela Marková, M.D.
General Hospital University in Prague
STUDY_DIRECTORRichard Plavka, prof.
General Hospital University in Prague
Outcome results
None listed