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

February 2, 2026 updated by: Institute of Health Information and Statistics of the Czech Republic

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
    • Czech Republic
      • Havlíčkův Brod, Czech Republic, Czechia
        • Recruiting
        • Hospital Havlíčkův Brod
        • Contact:
          • Magdalena Chvílová Weberová, weberova@onhb.cz
      • Liberec, Czech Republic, Czechia
      • Prague, Czech Republic, Czechia
        • Recruiting
        • General University Hospital
        • Contact:
      • České Budějovice, Czech Republic, Czechia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 5 year old children born prematurely
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of premature infants with identified pathology at 5 years (overall, by detected pathology)
Time Frame: During study participation (up to 3 days)
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)
During study participation (up to 3 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Health Information and Statistics of the Czech Republic

Collaborators

General University Hospital, Prague
České Budějovice Hospital
Hospital Havlickuv Brod
County Hospital Liberec, Liberec

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UZIS 2025/3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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