Nutritional Management of Neurologically Impaired Children Across China

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.

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Key information

Conditions

Neurological Impairments Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Real World Evidence Study: Improving Nutritional Management of Neurologically Impaired Children

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Sep 25, 2024
Registry last updated: Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed