Neurological ImpairmentsNCT06612736
Nutritional Management of Neurologically Impaired Children Across China
An observational study of Neurological Impairments, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
A retrospective study to (1) investigate clinical characteristics, nutritional status, and nutritional management in neurologically impaired children in China, (2) assess whether enteral nutrition (particularly tube feeding) contributes to improving nutritional outcomes in children with neurological impairments, (3)… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Neurological Impairments
- How many people
- 586 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2021to 1 May 2023
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with neurological impairments across China
Who may be able to join
- age≤18 years, (2) with primary, progressive or non-progressive neurological impairment, (3) received oral nutrition or tube feeding, (4) for tube-fed patients only: at least 1 month of nutritional intervention and at least 1 follow-up visit (i.e. at least at Visit 1)
Who cannot join
- with acquired causes of neurological damage (e.g., traumatic brain injury) or tube-fed patients who received nutritional intervention for less than a month and without follow-up
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127
About this study
Official title: Real World Evidence Study: Improving Nutritional Management of Neurologically Impaired Children
A retrospective study to (1) investigate clinical characteristics, nutritional status, and nutritional management in neurologically impaired children in China, (2) assess whether enteral nutrition (particularly tube feeding) contributes to improving nutritional outcomes in children with neurological impairments, (3) examine the tolerability of enteral nutrition and whether it can effectively reverse or prevent severe malnutrition.
Read the detailed description
Electronic health records of children with neurological impairments from 11 medical centers across China between 2015 and 2020 were reviewed. Data were analyzed using SPSS 22.0. Normally distributed data were presented as mean±standard deviation (SD), and non-normally distributed data were presented as median and interquartile range (IQR). Categorical data were presented as frequencies and analyzed using the chi-square test. The Wilcoxon test was used to compare data at different time points. Multivariate logistic regressions were used to analyze the factors influencing gastrointestinal symptoms.
- Conditions
- Neurological Impairments
- Keywords
- neurological impairment, enteral nutrition, children, nutritional management
- Medical subject headings
- Neurologic Manifestations
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight for age z-score
It indicates body weight of a children for their age and sex relative to the reference population. It is an important indicator of acute nutritional status in young children aged less than two years old.
Measured: From diagnosis to 24 months of follow-up
Height for age z-score
It indicates height of a children for their age and sex relative to the reference population. It is an important indicator of chronic nutritional status in children.
Measured: From diagnosis to 24 months of follow-up
BMI for age z-score
It indicates body mass index of a children for their age and sex relative to the reference population. It is an important indicator of acute nutritional status in children aged greater than two years old.
Measured: From diagnosis to 24 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start6 Dec 2021
- Primary completion1 Jan 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological ImpairmentsStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 586 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Hong, Shanghai Jiao Tong University School of Medicine
- Investigators
- Li Hong, MD, PhD, Principal investigator, Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612736
- Sponsor's protocol ID
- SCMCIRB-K2021078-1
- Status last verified
- Dec 2021
- First submitted
- 22 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Evidence Study: Improving Nutritional Management of Neurologically Impaired Children
- ClinicalTrials.gov ID
- NCT06612736
- Acronym / sponsor ID
- SCMCIRB-K2021078-1
- Conditions
- Neurological Impairments
- Keywords
- neurological impairment, enteral nutrition, children, nutritional management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 586 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 25 Sep 2024 (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.
A retrospective study to (1) investigate clinical characteristics, nutritional status, and nutritional management in neurologically impaired children in China, (2) assess whether enteral nutrition (particularly tube feeding) contributes to improving nutritional outcomes in children with neurological impairments, (3) examine the tolerability of enteral nutrition and whether it can effectively reverse or prevent severe malnutrition.
Detailed description
Electronic health records of children with neurological impairments from 11 medical centers across China between 2015 and 2020 were reviewed. Data were analyzed using SPSS 22.0. Normally distributed data were presented as mean±standard deviation (SD), and non-normally distributed data were presented as median and interquartile range (IQR). Categorical data were presented as frequencies and analyzed using the chi-square test. The Wilcoxon test was used to compare data at different time points. Multivariate logistic regressions were used to analyze the factors influencing gastrointestinal symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with neurological impairments across China
Key inclusion criteria (1 listed)
- age≤18 years, (2) with primary, progressive or non-progressive neurological impairment, (3) received oral nutrition or tube feeding, (4) for tube-fed patients only: at least 1 month of nutritional intervention and at least 1 follow-up visit (i.e. at least at Visit 1)
Key exclusion criteria (1 listed)
- with acquired causes of neurological damage (e.g., traumatic brain injury) or tube-fed patients who received nutritional intervention for less than a month and without follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Weight for age z-score
Time frame: From diagnosis to 24 months of follow-up
It indicates body weight of a children for their age and sex relative to the reference population. It is an important indicator of acute nutritional status in young children aged less than two years old.
Height for age z-score
Time frame: From diagnosis to 24 months of follow-up
It indicates height of a children for their age and sex relative to the reference population. It is an important indicator of chronic nutritional status in children.
BMI for age z-score
Time frame: From diagnosis to 24 months of follow-up
It indicates body mass index of a children for their age and sex relative to the reference population. It is an important indicator of acute nutritional status in children aged greater than two years old.
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 25 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
Li Hong, MD, PhD principal investigator
Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurological Impairments, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 1 inclusion and 1 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 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Weight for age z-score (time frame: From diagnosis to 24 months of follow-up). The study lists 3 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 25 Sep 2024.