Nutritional Management of Neurologically Impaired Children Across China

September 22, 2024 updated by: Li Hong, Shanghai Jiao Tong University School of Medicine

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

586

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children with neurological impairments across China

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From diagnosis to 24 months of follow-up
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.
From diagnosis to 24 months of follow-up
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.
From diagnosis to 24 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Li Hong, MD, PhD, Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2021

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

September 22, 2024

First Submitted That Met QC Criteria

September 22, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Actual)

September 25, 2024

Last Update Submitted That Met QC Criteria

September 22, 2024

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SCMCIRB-K2021078-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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