NCT06216379

Brief Summary

In the study, sensory processing skills of 1-year-old preterm and term children will be evaluated. The relationship between sensory processing skills and gross and fine motor development will be investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

January 11, 2024

Last Update Submit

January 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Test of Sensory Functions in Infants TSFI

    The Test of Sensory Functions in Infants (TSFI) is a standardized and reliable tool designed to evaluate the sensory development of infants aged 4-18 months. Consisting of 24 items, the TSFI measures reactions in five distinct subdomains: tactile deep pressure, visual-tactile integration, adaptive motor function, ocular motor function, and reactivity to vestibular stimulation \[1\]. A specific age-normalized score is generated for each subdomain, contributing to a total score determined by the sum of all subdomains. The total score ranges from 0 to 49, with higher scores indicating more typical sensory responsiveness and lower scores suggesting behaviors associated with sensory over-responsivity \[2\]. In this study, a physiotherapist administered the TSFI to assess the sensory development of infants.

    15 minutes

Secondary Outcomes (1)

  • Peabody Developmental Motor Scales-2

    30 minutes

Study Arms (2)

Preterm

Children born before 37 gestational weeks

Diagnostic Test: Assessment

Term

Children born after 37 weeks of gestation

Diagnostic Test: Assessment

Interventions

AssessmentDIAGNOSTIC_TEST

Sensory processing skills and gross and fine motor development of preterm and term born children were evaluated.

PretermTerm

Eligibility Criteria

Age12 Months - 12 Months
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Healthy children born preterm and term at 12 months of age

You may qualify if:

  • Premature group: Healthy children with a gestational age below 34 weeks Term group: Healthy children with gestational age between 37-41 weeks

You may not qualify if:

  • they had major congenital malformations, had genetic or chromosomal abnormalities, had known metabolic disorders, or had seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzurum Technical University

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature BirthPsychomotor Disorders

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gazi University

Study Record Dates

First Submitted

January 11, 2024

First Posted

January 22, 2024

Study Start

March 1, 2023

Primary Completion

August 1, 2023

Study Completion

December 1, 2023

Last Updated

January 22, 2024

Record last verified: 2024-01

Locations