Early Detection of Developmental Abnormalities of Preterm Infants at 5 Years of Age

NCT07391527 — Not applicable, Recruiting, 210 participants, Institute of Health Information and Statistics of the Czech Republic

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

RegistryNCT07391527
StatusRecruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, screening
Enrollment210 (Estimated)
SponsorInstitute 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
Conditions5 Year Old Children Born Prematurely
InterventionsPediatric check-up (Other)
Datesstart 2025-09-23, primary completion 2026-11-01 (estimated), completion 2027-02-28 (estimated), first posted 2026-02-06, last updated 2026-02-06
Locations4 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

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
5 year old children born prematurelyOtherOther: Pediatric check-up
  • Pediatric check-up (Other): 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).

+Outcome measures

Primary outcomes

  • 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)]

+Eligibility

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.

+Locations (4)

FacilityCityCountryStatus
České Budějovice HospitalČeské Budějovice, Czech RepublicCzechiaRecruiting
Hospital Havlíčkův BrodHavlíčkův Brod, Czech RepublicCzechiaRecruiting
County Hospital LiberecLiberec, Czech RepublicCzechiaRecruiting
General University HospitalPrague, Czech RepublicCzechiaRecruiting

+Investigators

  • Daniela Marková, M.D., Study director, General Hospital University in Prague
  • Richard Plavka, prof., Study director, General Hospital University in Prague