Cerebral PalsyNCT05581732
Study of the ONS "Nutrinidrink With Dietary Fiber" Use Effect on Some Health Indicators in Children With Cerebral Palsy
An observational study of Cerebral Palsy, run by Enrollme.ru, LLC at 3 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Nutrinidrink with Dietary Fiber
- How many people
- 56 participants
- Where
- 3 sitesRussia
- Study dates
- 1 Jun 2021to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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 locations and contacts
3 sites in 1 country.
Russia3 sites
Center for nutrition and biotechnology
Moscow
Scientific and Clinical Center for Children's Psychoneurology
Moscow
Child's Clinical Hospital by Ivanova
Samara
About this study
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)
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
- Being tested
- Nutrinidrink with Dietary Fiber
- Keywords
- Cerebral Palsy, Nutrition, Quality of Life, Bioimpedance, Z-score
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrinidrink with Dietary FiberDietary 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Body Mass Index
Measured: 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
Measured: 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
Measured: 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
Measured: during observation up to 16 weeks
Martinet-Kushelevsky test
Activity test to determine the level of physical abilities
Measured: during observation up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start1 Jun 2021
- Primary completion1 Jun 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enrollme.ru, LLC
- Sponsor type
- Research network
- Collaborators
- Danone Nutricia
- Responsible party
- Sponsor
- Investigators
- Mikhail A Getman, Dr, Study director, Enrollme.ru
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581732
- Sponsor's protocol ID
- NOCP
- Status last verified
- Jan 2023
- First submitted
- 12 Oct 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05581732
- Acronym / sponsor ID
- NOCP
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Nutrition, Quality of Life, Bioimpedance, Z-score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Enrollme.ru, LLCResearch network
- Collaborators
- Danone Nutricia
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | – | Dietary Supplement: Nutrinidrink with Dietary Fiber32 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 |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrinidrink with Dietary FiberNutrinidrink 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 | Dietary supplement | Study |
Primary outcome
BMI
Time frame: during observation up to 16 weeks
Body Mass Index
Z-score (BMI)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: during observation up to 16 weeks
Activity test to determine the level of physical abilities
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhail A Getman, Dr study director
Enrollme.ru
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Enrollme.ru, LLC at 3 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (time frame: during observation up to 16 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.