Psychomotor Development ImpairedNCT05930522
Psychomotor Performance of Preterm Infants
An observational study of Psychomotor Development Impaired, run by Gdansk University of Physical Education and Sport at 1 site in Poland.
Trial summary
The first part involved 120 children in grades II and III of elementary schools. From this group, children were qualified for the second part of the study - 35 randomly selected children born on time (BoT) and 35 children born before 35 weeks of pregnancy (PB). Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychomotor Development Impaired
- How many people
- 180 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2018to 30 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 180 healthy school children
Who may be able to join
- preterm born (PB): born before 35 weeks of gestation
- both groups: aged 7-9 y during the research project
Who cannot join
- musculoskeletal injuries
- neurological disorders or other CNS damage
Trial locations and contacts
1 site in 1 country.
Poland1 site
Gdansk University of Physical Education and Sport
Gdansk, Pomeranian Voivodeship, 80-336
About this study
Official title: Psychomotor Performance of Preterm Infants Born Between 24 and 35 Weeks of Gestation
The first part involved 120 children in grades II and III of elementary schools. From this group, children were qualified for the second part of the study - 35 randomly selected children born on time (BoT) and 35 children born before 35 weeks of pregnancy (PB). EUROFIT tests, Vienna Tests and postural stability tests were carried out in both groups.
- Conditions
- Psychomotor Development Impaired
- Keywords
- Preterm Birth, Preterm Infant, Motor abilities, Eurofit, Vienna test, Postural stability
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Eurofit test
Motor abilities
Measured: 20 minutes
Biodex Balance System SD
Static and dynamic postural stability
Measured: 15 minutes
Vienna Test
Speed reactions
Measured: 15 min minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Oct 2018
- Primary completion1 Feb 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychomotor Development ImpairedStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gdansk University of Physical Education and Sport
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paulina Ewertowska, PhD, Study chair, Gdansk University of Physical Education and Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930522
- Sponsor's protocol ID
- AWFiS/2023_3_PE
- Status last verified
- Jun 2023
- First submitted
- 26 Jun 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kozakiewicz M, Ewertowska P, Perzanowska E, Wilczynska D, Walczak-Kozlowska T, Orlikowska A, Markowicz M, Zajt J, Kaczor J. Understanding the challenges: preterm birth and middle childhood psychomotor skills - a case control study. BMC Pediatr. 2026 Jan 1;25(1):1004. doi: 10.1186/s12887-025-06356-3.
PubMed 41476303
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychomotor Performance of Preterm Infants Born Between 24 and 35 Weeks of Gestation
- ClinicalTrials.gov ID
- NCT05930522
- Acronym / sponsor ID
- AWFiS/2023_3_PE
- Conditions
- Psychomotor Development Impaired
- Keywords
- Preterm Birth, Preterm Infant, Motor abilities, Eurofit, Vienna test, Postural stability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Gdansk University of Physical Education and SportUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 5 Jul 2023 (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 first part involved 120 children in grades II and III of elementary schools. From this group, children were qualified for the second part of the study - 35 randomly selected children born on time (BoT) and 35 children born before 35 weeks of pregnancy (PB). EUROFIT tests, Vienna Tests and postural stability tests were carried out in both groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 180 healthy school children
Key inclusion criteria (2 listed)
- preterm born (PB): born before 35 weeks of gestation
- both groups: aged 7-9 y during the research project
Key exclusion criteria (2 listed)
- musculoskeletal injuries
- neurological disorders or other CNS damage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Eurofit test
Time frame: 20 minutes
Motor abilities
Biodex Balance System SD
Time frame: 15 minutes
Static and dynamic postural stability
Vienna Test
Time frame: 15 min minutes
Speed reactions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Derived from this study: PubMed 41476303Kozakiewicz M, Ewertowska P, Perzanowska E, Wilczynska D, Walczak-Kozlowska T, Orlikowska A, Markowicz M, Zajt J, Kaczor J. Understanding the challenges: preterm birth and middle childhood psychomotor skills - a case control study. BMC Pediatr. 2026 Jan 1;25(1):1004. doi: 10.1186/s12887-025-06356-3.
- Individual participant dataSharing planned: Undecided
Related trials for Psychomotor Development Impaired
Active, not recruitingObservational study
Iodine Impact on Thyroid Function and Psychomotor Development, Observational Study in the Portuguese Minho Region
Iodine Deficiency, Thyroid
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. This study is not recruiting at the moment.
Paulina Ewertowska, PhD study chair
Gdansk University of Physical Education and Sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychomotor Development Impaired, run by Gdansk University of Physical Education and Sport at 1 site in Poland.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eurofit test (time frame: 20 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05930522, which also lists 1 linked publication.
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 26 Sep 2023.