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| Name | Class |
|---|---|
| Danone Nutricia | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study | 32 patients in the study group received supplemental nutritional support with ONS "Nutrinidrink with Dietary Fiber" in a pre-calculated amount daily throughout the study for 14-16 weeks. During the hospital stay, additional nutritional support was added to the patient's standard hospital diet (ATC table). On an outpatient basis, the patient received the required amount of ONS at his disposal and add it as a supplement to his/her usual and habitual diet between main meals. |
| |
| Control | 24 patients in the control group adhered to the standard hospital diet (ATC table), and at discharge - the usual habitual diet |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrinidrink with Dietary Fiber | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| BMI | Body Mass Index | during observation up to 16 weeks |
| Z-score (BMI) | Body mass index z-scores are measures of relative weight adjusted for child age and sex | during observation up to 16 weeks |
| Bioelectrical impedance analysis | Device-based diagnostics to measure the voltage of weak electrical currents in order to calculate impedance (resistance) of the body | during observation up to 16 weeks |
| Gastrointestinal symptoms scale | A patient reported 5 score questionnaire to evaluate frequency and severity of gastrointestinal symptoms with 1 - minimal symptom manifestation, 5 - maximal symptom manifestation | during observation up to 16 weeks |
| Martinet-Kushelevsky test | Activity test to determine the level of physical abilities | during observation up to 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Boys and girls, aged 4-8 years with confirmed diagnosis of cerebral palsy, spastic and hyperkinetic forms (Class of cerebral palsy GMFCS 2-3) and Z-score BMI ≤ -1
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| Name | Affiliation | Role |
|---|---|---|
| Mikhail A Getman, Dr | Enrollme.ru | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for nutrition and biotechnology | Moscow | Russia | ||||
| Scientific and Clinical Center for Children's Psychoneurology |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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| Moscow |
| Russia |
| Child's Clinical Hospital by Ivanova | Samara | Russia |
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |