NCT07391527

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Sep 2025

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Sep 2025Feb 2027

Study Start

First participant enrolled

September 23, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

January 26, 2026

Last Update Submit

February 2, 2026

Conditions

5 Year Old Children Born Prematurely

Keywords

follow up of premature infantsearly detectiondevelopmental abnormalityCzech Republic

Outcome Measures

Primary Outcomes (2)

  • 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)

Study Arms (1)

5 year old children born prematurely

OTHER
Other: Pediatric check-up

Interventions

Pediatric check-upOTHER

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).

5 year old children born prematurely

Eligibility Criteria

Age5 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Unsigned consent for participation in the project and consent for the processing of personal data.
  • Severe psychomotor retardation .
  • Severe congenital malformations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

Study Officials

  • Daniela Marková, M.D.

    General Hospital University in Prague

    STUDY DIRECTOR

  • Richard Plavka, prof.

    General Hospital University in Prague

    STUDY DIRECTOR

Central Study Contacts

Daniela Dokoupilová, MSc

CONTACT

+420725441408daniela.dokoupilova@uzis.cz

Lucie Mandelová, Ph.D.

CONTACT

+420770190828lucie.mandelova@uzis.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 6, 2026

Study Start

September 23, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CZ(4)