Early Detection of Developmental Abnormalities of Preterm... | NCT07391527

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

NCT07391527

Sponsor

Institute of Health Information and Statistics of the Czech Republic

Status

Recruiting

Last Update Posted

Feb 6, 2026Actual

Enrollment

210Estimated

Phase

Not Applicable

Conditions

5 Year Old Children Born Prematurely

Interventions

Pediatric check-up

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 23, 2025Actual

Primary Completion Date

Nov 2026Estimated

Completion Date

Feb 28, 2027Estimated

First Submitted Date

Jan 26, 2026

First Submission Date that Met QC Criteria

Feb 2, 2026

First Posted Date

Feb 6, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2026

Last Update Posted Date

Feb 6, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Institute of Health Information and Statistics of the Czech RepublicOTHER_GOV

Collaborators

Name	Class
České Budějovice Hospital	OTHER
General University Hospital, Prague	OTHER
Hospital Havlickuv Brod	UNKNOWN
County Hospital Liberec, Liberec

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

210Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
5 year old children born prematurely	Other		Other: Pediatric check-up

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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).

Outcomes Module

Primary Outcomes

Measure	Description	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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Daniela Dokoupilová, MSc	Contact	+420725441408		daniela.dokoupilova@uzis.cz
Lucie Mandelová, Ph.D.	Contact	+420770190828		lucie.mandelova@uzis.cz

Overall Officials

Name	Affiliation	Role
Daniela Marková, M.D.	General Hospital University in Prague	Study Director
Richard Plavka, prof.	General Hospital University in Prague	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
České Budějovice Hospital	Recruiting	České Budějovice	Czech Republic		Czechia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided