Study of the ONS "Nutrinidrink With Dietary Fiber" Use Effect on Some Health Indicators in Children With Cerebral Palsy

Sponsor

Enrollme.ru, LLC (Other)

Overall Status

Completed

CT.gov ID

NCT05581732

Collaborator

Danone Nutricia (Industry)

Enrollment

Locations

Actual Duration (Months)

18.7

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy	Dietary Supplement: Nutrinidrink with Dietary Fiber

Study Design

Study Type:

Observational

Actual Enrollment :

56 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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)

Actual Study Start Date :

Jun 1, 2021

Actual Primary Completion Date :

Jun 1, 2022

Actual Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Dietary Supplement: Nutrinidrink 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
Control 24 patients in the control group adhered to the standard hospital diet (ATC table), and at discharge - the usual habitual diet

Arm

Intervention/Treatment

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.

Dietary Supplement: Nutrinidrink 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

Control

24 patients in the control group adhered to the standard hospital diet (ATC table), and at discharge - the usual habitual diet

Outcome Measures

Primary Outcome Measures

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
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
Martinet-Kushelevsky test [during observation up to 16 weeks]
Activity test to determine the level of physical abilities

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 8 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Center for nutrition and biotechnology	Moscow	Russian Federation
2	Scientific and Clinical Center for Children's Psychoneurology	Moscow	Russian Federation
3	Child's Clinical Hospital by Ivanova	Samara	Russian Federation