Real World Evidence Study: Improving Nutritional Management of Neurologically Impaired Children
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neurological Impairments
- Sponsor
- Shanghai Jiao Tong University School of Medicine
- Enrollment
- 586
- Locations
- 1
- Primary Endpoint
- Weight for age z-score
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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) 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.
Investigators
Li Hong
Vice President at Shanghai Children's Medical Center
Shanghai Jiao Tong University School of Medicine
Eligibility Criteria
Inclusion Criteria
- •(1) 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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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.