Psychomotor Performance of Preterm Infants | NCT05930522

Studies
Psychomotor Performance of Preterm Infants

NCT05930522

Sponsor

Gdansk University of Physical Education and Sport

Status

Completed

Last Update Posted

Sep 26, 2023Actual

Enrollment

180Actual

Phase

Not provided

Conditions

Psychomotor Development Impaired

Interventions

Not provided

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2018Actual

Primary Completion Date

Feb 1, 2020Actual

Completion Date

Mar 30, 2020Actual

First Submitted Date

Jun 26, 2023

First Submission Date that Met QC Criteria

Jun 26, 2023

First Posted Date

Jul 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2023

Last Update Posted Date

Sep 26, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Eurofit test	Motor abilities	20 minutes
Biodex Balance System SD	Static and dynamic postural stability	15 minutes
Vienna Test	Speed reactions	15 min minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

9 Years

Standard Ages

Child

Study Population

180 healthy school children

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paulina Ewertowska, PhD	Gdansk University of Physical Education and Sport	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gdansk University of Physical Education and Sport		Gdansk	Pomeranian Voivodeship	80-336	Poland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41476303	Derived	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.

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications