Evaluation of Long-term Neurodevelopment in Neonatal Encephalopathy by Infant Treadmill

December 27, 2023 updated by: Children's Hospital of Fudan University

A Randomized Clinical Trial of Infant Treadmill for Long-term Neurodevelopmental Evaluation of Neonatal Encephalopathy

There is no international application of infant running stimulation system to evaluate the brain injury in children with various stages of nerve and motor development in a large sample of studies. The study of neonatal brain injury is only limited to intraventricular hemorrhage(IVH),periventricular leukomalacia(PVL), Down's syndrome(DS), premature birth of these four conditions, and the number of samples in the single digits, there is no representative of the disease population. Therefore, from the newborn to the infant development of the critical period, the investigator will refer to the previous treadmill parameters set on the research results, optimize the application of neonatal treadmill. The study hypothesized that neonatal treadmill stimulation with brain-injured children could improve his / her staggered gait characteristics and long-term nerve development through large sample data. It is important to preserve and analyze the gait characteristics and the changes of nerve development in every stage of growth and development of neonates with brain injury so as to provide clinical evidence for rehabilitation intervention. It is of great significance to judge whether this technique can be used in the early stage of brain injury in neonates.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

There is no international application of infant running stimulation system to evaluate the brain injury in children with various stages of nerve and motor development in a large sample of studies. The study of neonatal brain injury is only limited to intraventricular hemorrhage(IVH),periventricular leukomalacia(PVL), Down's syndrome(DS), premature birth of these four conditions, and the number of samples in the single digits, there is no representative of the disease population. Therefore, from the newborn to the infant development of the critical period, the investigators will refer to the previous treadmill parameters set on the research results, optimize the application of neonatal treadmill. The study hypothesized that neonatal treadmill stimulation with brain-injured children could improve his / her staggered gait characteristics and long-term nerve development through large sample data. It is important to preserve and analyze the gait characteristics and the changes of nerve development in every stage of growth and development of neonates with brain injury so as to provide clinical evidence for rehabilitation intervention. It is of great significance to judge whether this technique can be used in the early stage of brain injury in neonates.

Study Type

Interventional

Phase

  • Not Applicable

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, 201102
        • Children Hospital of Fudan University

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

3 months to 1 year (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Gestational age < 33 weeks;
  2. Correction of gestational age < 3 months;
  3. It has been diagnosed as hypoxic-ischemic encephalopathy, periventricular intraventricular hemorrhage, periventricular leukomalacia, bilirubin encephalopathy, persistent hypoglycemia and cerebral infarction.
  4. There was no other therapeutic intervention before entering the study;
  5. Informed consent is signed by the family.

Exclusion Criteria:

This study is excluded from the study provided that one of the following conditions is met:

  1. Brain injury caused by central or peripheral infection (cerebrospinal fluid positive / torch test positive / three major conventional culture positive);
  2. Brain damage caused by convulsion;
  3. Metabolic brain damage caused by genetic defects;
  4. Suffering from known severe congenital malformations;
  5. Definite head trauma during labor or postpartum;
  6. Peripheral neuromuscular disease or abnormal skeletal system.

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
Baby treadmill + physical rehabilitation training
Device: Baby treadmill
The newborns who received treadmill intervention were stimulated by running 3 times a week for a total of 10 minutes each time (complete in 5 cycles, 2 minutes per cycle, 2 minutes after the completion of one cycle and rest for 2 minutes to start the next cycle). Until the completion and completion of the five cycles). During the remaining four days of each week, other physical rehabilitation training is carried out by the rehabilitator in accordance with the established rehabilitation plan. The stimulation of running lasted from 3 months of corrected gestational age to being able to walk alone for 3 steps or to correct for 18 months.
Behavioral: Physical rehabilitation training
Suitable for general physical rehabilitation training of all infants with cerebral palsy.
Active Comparator: positive control group
Physical rehabilitation training only
Behavioral: Physical rehabilitation training
Suitable for general physical rehabilitation training of all infants with cerebral palsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
score from Bayley Scales of Infant and Toddler Development testing
Time Frame: The length of time from birth to the corrected age of 18 months
These scores are largely used for screening, helping to identify the need for further observation and intervention, as infants who score very low are at risk for future developmental problems.
The length of time from birth to the corrected age of 18 months
fractional anisotropy(FA)
Time Frame: The length of time from birth to the corrected age of 18 months
a variable from Diffusion Tensor Image（DTI）sequence of MRI
The length of time from birth to the corrected age of 18 months
the value of Amplitude of Low Frequency Fluctuation(ALFF)
Time Frame: The length of time from birth to the corrected age of 18 months
a variable from resting-blood oxygenation level dependent（BOLD）sequence of MRI
The length of time from birth to the corrected age of 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alberta Infant Motor Development Assessment
Time Frame: The length of time from birth to the corrected age of 18 months
Neurodevelopmental evaluation scale
The length of time from birth to the corrected age of 18 months
Peabody motor development scale
Time Frame: The length of time from birth to the corrected age of 18 months
The Peabody Developmental Motor Scales (PDMS) is composed of six subtests that measure interrelated abilities in early motor development. It was designed to assess gross and fine motor skills in children from birth through five years of age. Reflexes (Re), Stationary (St), Locomotion (Lo) , Object Manipulation (Ob), Grasping (Gr), Visual-Motor Integration (Vi). All of the PDMS-2 subtests contribute to a Total Motor Quotient (TMQ).
The length of time from birth to the corrected age of 18 months
Gross Motor Function Measure Scale
Time Frame: The length of time from birth to the corrected age of 18 months
There is a 4-point scoring system for each item on the GMFM. Specific descriptors for scoring items are detailed in the administration and scoring guidelines. The GMFM-66 requires a user-friendly computer programme called the Gross Motor Ability Estimator, or GMAE, to enter individual item scores and convert them to an interval level total score.
The length of time from birth to the corrected age of 18 months
the value of regional homogeneity (ReHo)
Time Frame: Corrected age of 18 months
a variable from resting-blood oxygenation level dependent（BOLD）sequence of MRI
Corrected age of 18 months
mean diffusion(MD)
Time Frame: The length of time from birth to the corrected age of 18 months
a variable from Diffusion Tensor Image（DTI） sequence of MRI
The length of time from birth to the corrected age of 18 months

Collaborators and Investigators

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

Sponsor

Children's Hospital of Fudan University

Collaborators

Shanghai 6F+ Early intervention center for high risk preterm infants

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 1, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

February 22, 2018

First Submitted That Met QC Criteria

May 16, 2018

First Posted (Actual)

May 17, 2018

Study Record Updates

Last Update Posted (Actual)

December 29, 2023

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHFudanU_NNICU8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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