NCT02889887

Brief Summary

The aim of this study is to analyse correlation between the sensory processing and motor development in preterm infants.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

Status
unknown

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, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

September 7, 2016

Status Verified

August 1, 2016

Enrollment Period

3 months

First QC Date

August 22, 2016

Last Update Submit

September 6, 2016

Conditions

Sensation Disorders

Keywords

PretermSensory ProcessingMotor Development

Outcome Measures

Primary Outcomes (1)

  • The investigation of sensory processing in preterm infants

    Test of Sensory Function in Infants' was used to evaluate sensory processing in preterm infants.

    Day 1

Secondary Outcomes (1)

  • The investigation of motor development in preterm infants

    Day 1

Study Arms (1)

preterm

infants who born before 37 completed weeks

Eligibility Criteria

Age10 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

A total of 60 infants who were born preterm (n=30) and term (n=30), the corrected and chronological ages between 10-12 months, were included in this study.

You may qualify if:

  • gestational age lower than 37 month
  • corrected age within 10-12 months
  • without congenital anomaly or systemic disease
  • stay in Neonatal Intensive Care Unit (NICU) at least 2 weeks

You may not qualify if:

  • taken physiotherapy or sensory integration therapy in any rehabilitation center
  • having newborn retinopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Celik HI, Elbasan B, Gucuyener K, Kayihan H, Huri M. Investigation of the Relationship Between Sensory Processing and Motor Development in Preterm Infants. Am J Occup Ther. 2018 Jan/Feb;72(1):7201195020p1-7201195020p7. doi: 10.5014/ajot.2018.026260.

    PMID: 29280716DERIVED

MeSH Terms

Conditions

Sensation DisordersPremature Birth

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • HALİL İ ÇELİK

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

August 22, 2016

First Posted

September 7, 2016

Study Start

March 1, 2016

Primary Completion

June 1, 2016

Study Completion

October 1, 2016

Last Updated

September 7, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share