- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05930522
Psychomotor Performance of Preterm Infants
September 22, 2023 updated by: Gdansk University of Physical Education and Sport
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
180
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pomorskie
-
Gdańsk, Pomorskie, Poland, 80-336
- Gdansk University of Physical Education and Sport
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
180 healthy school children
Description
Inclusion Criteria:
- preterm born (PB): born before 35 weeks of gestation
- both groups: aged 7-9 y during the research project
Exclusion Criteria:
- musculoskeletal injuries
- neurological disorders or other CNS damage
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eurofit test
Time Frame: 20 minutes
|
Motor abilities
|
20 minutes
|
Biodex Balance System SD
Time Frame: 15 minutes
|
Static and dynamic postural stability
|
15 minutes
|
Vienna Test
Time Frame: 15 min minutes
|
Speed reactions
|
15 min minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Paulina Ewertowska, PhD, Gdansk University of Physical Education and Sport
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Actual)
February 1, 2020
Study Completion (Actual)
March 30, 2020
Study Registration Dates
First Submitted
June 26, 2023
First Submitted That Met QC Criteria
June 26, 2023
First Posted (Actual)
July 5, 2023
Study Record Updates
Last Update Posted (Actual)
September 26, 2023
Last Update Submitted That Met QC Criteria
September 22, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AWFiS/2023_3_PE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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