NCT02777645

Brief Summary

The nutritional status of CP children may be decreased when children have chewing disorders too due to insufficient solid food intake. The objective of this study was to investigate growth, dietary intakes and feeding behaviours of children with CP who have chewing disorders, and to compare them with their healthy peers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

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, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 19, 2016

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

2 months

First QC Date

May 13, 2016

Last Update Submit

May 18, 2016

Conditions

Cerebral PalsyMastication DisorderMalnutritionGrowth Delay

Outcome Measures

Primary Outcomes (1)

  • Growth of children with cerebral palsy (CP) who have chewing disorders (Z-scores)

    Z-scores of the nutritional indicators were calculated.

    3 months

Secondary Outcomes (2)

  • Dietary intakes of children with cerebral palsy (CP) who have chewing disorders (dietary assessment)

    3 months

  • Feeding behaviours of children with cerebral palsy (CP) who have chewing disorders (BPFAS)

    3 months

Study Arms (2)

Study group

Study group(n=50) included CP children with chewing disorder. Growth, feeding evaluation will be done.

Other: Growth, feeding evaluation

Control group

Control group(n=35)= healthy children without chewing disorder Growth, feeding evaluation will be done.

Other: Growth, feeding evaluation

Interventions

Growth, feeding evaluationOTHER

Z-scores of the nutritional indicators were calculated. The dietary assessment was performed by using the 24-hour recall method. The Behavioural Paediatrics Feeding Assessment Scale (BPFAS) was used to assess both frequencies of negative feeding behaviours and parents' problematic perceptions

Control groupStudy group

Eligibility Criteria

Age24 Months - 61 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Group I (study group) (n=50) included CP children with chewing disorders and group II (control group) (n=35) included healthy children without chewing disorders

You may qualify if:

  • Study group
  • Children with cerebral palsy
  • Having complaints about chewing function
  • Do not manage solid food intake
  • Above the age of 18 months Control group
  • Healthy children
  • No complaints about chewing function
  • Can manage solid food intake
  • Above the age of 18 months

You may not qualify if:

  • Under the age of 18 months
  • Requiring tube feeding or taking any oral nutritional supplements
  • Using any medicine and/or oral appliances that could affect the chewing performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacetttepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral PalsyMalnutrition

Interventions

Growth

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological Phenomena

Study Officials

  • Selen SEREL ARSLAN, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, PhD

Study Record Dates

First Submitted

May 13, 2016

First Posted

May 19, 2016

Study Start

March 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 19, 2016

Record last verified: 2016-05

Locations

TU(1)