NCT04130880

Brief Summary

The purpose of this study is to test the reliability and validity of the Turkish Montreal Children's Hospital Feeding Scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

October 29, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
Last Updated

March 16, 2020

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

October 16, 2019

Last Update Submit

March 13, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Montreal Children's Hospital Feeding Scale

    The Montreal Children's Hospital Feeding Scale is used to evaluate feeding disorders. It has 14 items which are scored on a 7 point Likert scale. Seven items are scored from the negative to positive direction, and the other seven from the positive to negative direction. The primary feeder marks each item according to frequency or difficulty level of a particular behaviour or the level of parental concern. The total feeding problem score is obtained by adding the scores for each item after reversing the scores of seven items from negative to positive.

    2 months

Secondary Outcomes (1)

  • Behavioral Pediatrics Feeding Assessment Scale

    2 months

Study Arms (2)

Children with cerebral palsy

Children with CP who aged between 18 months and 6 years will be evaluated.

Diagnostic Test: Turkish Montreal Children's Hospital Feeding Scale

Children with typical development

Children with typical development who aged between 18 months and 6 years will be evaluated.

Diagnostic Test: Turkish Montreal Children's Hospital Feeding Scale

Interventions

The Turkish version of the Montreal Children's Hospital Feeding Scale, and the Behavioral Pediatrics Feeding Assessment Scale will be completed.

Children with cerebral palsyChildren with typical development

Eligibility Criteria

Age18 Months - 6 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children with cerebral palsy and Children with typical development

You may qualify if:

  • Children with cerebral palsy
  • Children with typical development
  • Aged between 18 months- 6 years

You may not qualify if:

  • Who aged under the age of 18 months and above the age of 6 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Özgü İnal

Edirne, 22100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • ÖZGÜ İNAL

    Trakya University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 18, 2019

Study Start

October 29, 2019

Primary Completion

December 15, 2019

Study Completion

December 15, 2019

Last Updated

March 16, 2020

Record last verified: 2020-02

Locations