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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02777645
Other study ID # ArslanSerel1
Secondary ID
Status Completed
Phase N/A
First received May 13, 2016
Last updated May 18, 2016
Start date March 2016
Est. completion date May 2016

Study information

Verified date May 2016
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational

Clinical Trial 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.


Description:

Chewing function is defined as a rhythmic oral motor activity to comminute and soften solid food. Children with CP often have difficulty in transitioning to solid food. The main food of 45% of them was liquids and semisolids. It was reported that food/fluid textures were modified for 39% of children in which with poorer gross motor function tended to receive a greater proportion of energy from fluids in their diets and fewer chewable foods. Lopes et al. investigated dietary patterns of 90 children with CP aged 2-13 years by using the 24-hour recall method and found that 26% and 9% of children had difficulty in chewing and swallowing of solid foods, respectively. However, the diet of children with normal feeding skills includes liquid, semisolid and/or solid foods together so unable to take any solid food may affect sufficient food intake and nutritional status of children with CP who have chewing disorders. The significance of this situation is that nutritional status has effects on general health and quality of life of children and their families. Therefore, it is important to show the nutritional status of CP children with chewing disorders to increase the awareness of both parents and healthcare providers on solid food intake and solve the problem early. 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.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 24 Months to 61 Months
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Intervention

Other:
Growth, feeding evaluation
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

Locations

Country Name City State
Turkey Hacetttepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Growth of children with cerebral palsy (CP) who have chewing disorders (Z-scores) Z-scores of the nutritional indicators were calculated. 3 months Yes
Secondary Dietary intakes of children with cerebral palsy (CP) who have chewing disorders (dietary assessment) The dietary assessment was performed by using the 24-hour recall method. 3 months Yes
Secondary Feeding behaviours of children with cerebral palsy (CP) who have chewing disorders (BPFAS) The Behavioural Paediatrics Feeding Assessment Scale (BPFAS) was used to assess both frequencies of negative feeding behaviours and parents' problematic perceptions. 3 months Yes
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