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

Enrollme.ru

Status: Completed

Conditions: Cerebral Palsy

Treatments: Dietary Supplement: Nutrinidrink with Dietary Fiber

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT05581732

NOCP

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: No 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

Trial design

56 participants in 2 patient groups

Study

Description:

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.

Treatment:

Dietary Supplement: Nutrinidrink with Dietary Fiber

Control

Description:

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