Nutritional Management of Neurologically Impaired Children Across China

NCT06612736 | Completed

• 1 other identifier: SCMCIRB-K2021078-1
• Study Type: observational
• Target: 586
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurological Impairments

Keywords

neurological impairment; enteral nutrition; children; nutritional management

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  From diagnosis to 24 months of follow-up

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with neurological impairments across China

You may qualify if:

• (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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Neurologic Manifestations

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Li Hong, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President at Shanghai Children's Medical Center

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: September 25, 2024
• Study Start: December 6, 2021
• Primary Completion: January 1, 2023
• Study Completion: May 1, 2023
• Last Updated: September 25, 2024

Record last verified: 2021-12

Locations

CN (1)