5 Year Old Children Born PrematurelyNCT07391527
Early Detection of Developmental Abnormalities of Preterm Infants at 5 Years of Age
A study testing Pediatric check-up in people with 5 Year Old Children Born Prematurely, run by Institute of Health Information and Statistics of the Czech Republic at 4 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 5 years
- Conditions the study is for
- 5 Year Old Children Born Prematurely
- What is being tested?
- Pediatric check-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 4 sitesCzechia
- Study dates
- 23 Sep 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Unsigned consent for participation in the project and consent for the processing of personal data.
- Severe psychomotor retardation .
- Severe congenital malformations.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia4 sites, 4 recruiting
- Recruiting
České Budějovice Hospital
České Budějovice, Czech Republic
Kateřina Matějová, MD, katerina.matejova@nemcb.cz
- Recruiting
Hospital Havlíčkův Brod
Havlíčkův Brod, Czech Republic
Magdalena Chvílová Weberová, weberova@onhb.cz
- Recruiting
County Hospital Liberec
Liberec, Czech Republic
Evženie Knězů, MD, evzenie.knezu@nemlib.cz
- Recruiting
General University Hospital
Prague, Czech Republic
Daniela Marková, MD, +420 602 644 481, daniela.markova@vfn.cz
About this study
Official title: 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.
Read the 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.
- Conditions
- 5 Year Old Children Born Prematurely
- Being tested
- Pediatric check-up
- Keywords
- follow up of premature infants, early detection, developmental abnormality, Czech Republic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 5 year old children born prematurely | Other | Not described Receives: Other: Pediatric check-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of premature infants with identified pathology at 5 years (overall, by detected pathology)
Measured: During study participation (up to 3 days)
Proportion of premature infants referred to a specialized center (overall, by detected pathology)
Measured: During study participation (up to 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start23 Sep 2025
- Primary completionFeb 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 5 Year Old Children Born PrematurelyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Health Information and Statistics of the Czech Republic
- Sponsor type
- Other government
- Collaborators
- České Budějovice Hospital, General University Hospital, Prague, Hospital Havlickuv Brod, County Hospital Liberec, Liberec
- Responsible party
- Sponsor
- Investigators
- Daniela Marková, M.D., Study director, General Hospital University in PragueRichard Plavka, prof., Study director, General Hospital University in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391527
- Sponsor's protocol ID
- UZIS 2025/3
- Status last verified
- Nov 2026
- First submitted
- 26 Jan 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection and Prevention of Health Complications in Premature Infants - Early Detection of Developmental Abnormalities of Preterm Infants at 5 Years of Age
- ClinicalTrials.gov ID
- NCT07391527
- Acronym / sponsor ID
- UZIS 2025/3
- Conditions
- 5 Year Old Children Born Prematurely
- Keywords
- follow up of premature infants, early detection, developmental abnormality, Czech Republic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Institute of Health Information and Statistics of the Czech RepublicOther government
- Collaborators
- České Budějovice Hospital, General University Hospital, Prague, Hospital Havlickuv Brod, County Hospital Liberec, Liberec
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5 year old children born prematurely | Other | Other: Pediatric check-up |
Who may qualify
- Ages
- 5 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Unsigned consent for participation in the project and consent for the processing of personal data.
- Severe psychomotor retardation .
- Severe congenital malformations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pediatric check-upEligible 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). | Other | 5 year old children born prematurely |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniela Marková, M.D. study director
General Hospital University in Prague
Richard Plavka, prof. study director
General Hospital University in Prague
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pediatric check-up in people with 5 Year Old Children Born Prematurely, run by Institute of Health Information and Statistics of the Czech Republic at 4 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniela Dokoupilová, MSc (+420725441408, daniela.dokoupilova@uzis.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of premature infants with identified pathology at 5 years (overall, by detected pathology) (time frame: During study participation (up to 3 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.