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

NCT05581732 | Completed

• 1 other identifier: NOCP
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 3

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.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy; Nutrition; Quality of Life; Bioimpedance; Z-score

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

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

Control

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

Interventions

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

Study

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Enrollme.ru, LLC: lead
• Danone Nutricia: collaborator

Study Sites (3)

Center for nutrition and biotechnology

Moscow, Russia

Location

Scientific and Clinical Center for Children's Psychoneurology

Moscow, Russia

Location

Child's Clinical Hospital by Ivanova

Samara, Russia

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Mikhail A Getman, Dr

  Enrollme.ru

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 14, 2022
• Study Start: June 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: August 1, 2022
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

RU (3)