Cerebral Palsy
Conditions
Keywords
Cerebral Palsy, Nutrition, Quality of Life, Bioimpedance, Z-score
Brief summary
The goal of this low-interventional study was to study the effect of additional nutritional support with ONS Nutrinidrink with dietary fiber on the anthropometric parameters of patients and the dynamics of gastrointestinal symptoms in patients with cerebral palsy. Among the additional objectives were to study the quality of life, metabolic parameters and the dynamics of some functional parameters of patients. Possible adverse events were also studied and described.
Interventions
DIETARY_SUPPLEMENTNutrinidrink with Dietary Fiber
Nutrinidrink with Dietary Fiber is a specialized nutrition for children during illness and recovery period, as well as with increased protein and energy needs: mental and / or physical stress, chronic diseases, growth and / or weight deficiency
Sponsors
Danone Nutricia
Enrollme.ru, LLC
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of cerebral palsy, spastic and hyperkinetic forms; * Class of cerebral palsy GMFCS 2-3; * Z-score BMI ≤ -1; * The patient's ability to safely swallow liquid food; * Availability of informed consent signed by the patient's legal representative for inclusion in the study and processing of personal data.
Exclusion criteria
* Individual intolerance to the investigational product components; * Galactosemia; * Allergy to cow's milk proteins and other food intolerances; * Participation in another clinical study currently or in the past 30 days; * Any other medical or non-medical reason that, in the physician's opinion, may prevent the patient from participating in the study. * Deterioration of the patient's condition requiring his transfer to enteral or parenteral nutrition; * Transfer of a patient to another hospital; * Complications that could be caused by the investigational product (diarrhea, nausea, vomiting, allergies, etc.); * Withdrawal for a safety reason * Refusal of the patient (his legal representative) from further participation in the study and withdrawal of informed consent to participate in the study and the processing of personal data. At the same time, the exclusion of a patient from the study should not affect the nature of his therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal symptoms scale | during observation up to 16 weeks | A patient reported 5 score questionnaire to evaluate frequency and severity of gastrointestinal symptoms with 1 - minimal symptom manifestation, 5 - maximal symptom manifestation |
| BMI | during observation up to 16 weeks | Body Mass Index |
| Z-score (BMI) | during observation up to 16 weeks | Body mass index z-scores are measures of relative weight adjusted for child age and sex |
| Bioelectrical impedance analysis | during observation up to 16 weeks | Device-based diagnostics to measure the voltage of weak electrical currents in order to calculate impedance (resistance) of the body |
| Martinet-Kushelevsky test | during observation up to 16 weeks | Activity test to determine the level of physical abilities |
Countries
Russia
Outcome results
None listed