NCT06065904
Not yet recruiting
Not Applicable
Exploring the Efficacy of a Comprehensive Nutritional Intervention for Children With Cerebral Palsy and ASD: A Randomized Controlled Trial at a Single Center
Silviya Pavlova Nikolova, PhD0 sites200 target enrollmentOctober 1, 2023
ConditionsNutrition Disorder, Child
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Nutrition Disorder, Child
- Sponsor
- Silviya Pavlova Nikolova, PhD
- Enrollment
- 200
- Primary Endpoint
- bedridden days monthsmean duration of bedridden days over six months
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The study is a prospective, single-center, randomized controlled trial that will be conducted at the Medical University of Varna. This setting offers access to a wealth of clinical expertise in managing CP and ASD and a rich tradition of conducting robust nutritional interventions.
Investigators
Silviya Pavlova Nikolova, PhD
The research is financed by the European Union-NextGenerationEU, through the National Recovery and Resilience Plan of the Republic of Bulgaria, project № BG-RRP-2.004-0009-C02.
Medical University of Varna
Eligibility Criteria
Inclusion Criteria
- •A formal diagnosis made by a qualified neurologist. The diagnosis can span across the different types of CP and ASD.
- •Expressed willingness to participate in the study.
- •Availability for the entire duration of the study.
Exclusion Criteria
- •Children with acute medical conditions or comorbidities that may significantly disrupt study assessments.
- •Any severe infections within the last 10 days prior to the study.
- •Presence of genetic syndromes that could influence nutritional status, e.g., Silver Russel syndrome or Down syndrome.
- •Parents with cognitive impairments, which might pose challenges in their participation during assessments/intervention.
- •Children who have been part of any major dietary or nutritional interventions in the last three months.
Outcomes
Primary Outcomes
bedridden days monthsmean duration of bedridden days over six months
Time Frame: six months
mean duration of bedridden days
Secondary Outcomes
- Number of social interactions per week with non-family members(six months)
- Height-for-Age Z-Score(six months)
- Number of Leisure Activities per Month(six months)
- BMI-for-Age Z-Score(six months)
- Weight-for-Age Z-Score(six months)
- Total Days of School or Kindergarten Attendance per month(six month)
- Total Number of New Spoken Words per Month(six months)
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