NCT05930522

Brief 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). EUROFIT tests, Vienna Tests and postural stability tests were carried out in both groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
Last Updated

September 26, 2023

Status Verified

June 1, 2023

Enrollment Period

1.3 years

First QC Date

June 26, 2023

Last Update Submit

September 22, 2023

Conditions

Psychomotor Development Impaired

Keywords

Preterm BirthPreterm InfantMotor abilitiesEurofitVienna testPostural stability

Outcome Measures

Primary Outcomes (3)

  • Eurofit test

    Motor abilities

    20 minutes

  • Biodex Balance System SD

    Static and dynamic postural stability

    15 minutes

  • Vienna Test

    Speed reactions

    15 min minutes

Eligibility Criteria

Age7 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

180 healthy school children

You may qualify if:

  • preterm born (PB): born before 35 weeks of gestation
  • both groups: aged 7-9 y during the research project

You may not qualify if:

  • musculoskeletal injuries
  • neurological disorders or other CNS damage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gdansk University of Physical Education and Sport

Gdansk, Pomeranian Voivodeship, 80-336, Poland

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Paulina Ewertowska, PhD

    Gdansk University of Physical Education and Sport

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2023

First Posted

July 5, 2023

Study Start

October 1, 2018

Primary Completion

February 1, 2020

Study Completion

March 30, 2020

Last Updated

September 26, 2023

Record last verified: 2023-06

Locations

PL(1)