Recruiting

NCT Number: NCT07391527

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.

Recruiting

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Key information

Conditions

5 Year Old Children Born Prematurely

Age range

5 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Havlíčkův Brod, Havlíčkův Brod, Czech Republic, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

Proportion of premature infants with identified pathology at 5 years (overall, by detected pathology)

Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Daniela Dokoupilová, MSc

CONTACT

[email protected]

+420725441408

Lucie Mandelová, Ph.D.

CONTACT

[email protected]

+420770190828

Sponsors and collaborators

Lead sponsor

Institute of Health Information and Statistics of the Czech Republic

Other Gov

Collaborators

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

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Feb 6, 2026
Registry last updated: Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.