Clinical trial NCT05581732: Study of the ONS "Nutrinidrink With Dietary Fiber" Use Effect on Some Health Indicators in Children With Cerebral Palsy
Official title: Russian Prospective Open Comparative in Two Groups, Low-interventional Study on the Effect of the Oral Nutrition Supplement (ONS) "Nutrinidrink With Dietary Fiber" on the Health Indicators in Children With Cerebral Palsy (CP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Nutrition
Quality of Life
Bioimpedance
Z-score
Lead sponsor: Enrollme.ru, LLC
Sponsor class: NETWORK
Collaborators: name: Danone Nutricia
First posted: 2022-10-14
Enrollment: 56
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.


Eligibility criteria: 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

Primary outcomes:
measure: BMI
timeFrame: during observation up to 16 weeks
measure: Z-score (BMI)
timeFrame: during observation up to 16 weeks
measure: Bioelectrical impedance analysis
timeFrame: during observation up to 16 weeks
measure: Gastrointestinal symptoms scale
timeFrame: during observation up to 16 weeks
measure: Martinet-Kushelevsky test
timeFrame: during observation up to 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Center for nutrition and biotechnology
city: Moscow
country: Russian Federation
facility: Scientific and Clinical Center for Children's Psychoneurology
city: Samara
country: Russian Federation
facility: Child's Clinical Hospital by Ivanova
Study officials:
affiliation: Enrollme.ru
name: Mikhail A Getman, Dr
role: STUDY_DIRECTOR
References: