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

Primary Purpose

Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia, Intraventricular Hemorrhage

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Baby treadmill
Physical rehabilitation training
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypoxic-Ischemic Encephalopathy

Eligibility Criteria

3 Months - 18 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children Hospital of Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

intervention group

positive control group

Arm Description

Baby treadmill + physical rehabilitation training

Physical rehabilitation training only

Outcomes

Primary Outcome Measures

score from Bayley Scales of Infant and Toddler Development testing
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.
fractional anisotropy(FA)
a variable from Diffusion Tensor Image(DTI)sequence of MRI
the value of Amplitude of Low Frequency Fluctuation(ALFF)
a variable from resting-blood oxygenation level dependent(BOLD)sequence of MRI

Secondary Outcome Measures

Alberta Infant Motor Development Assessment
Neurodevelopmental evaluation scale
Peabody motor development scale
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).
Gross Motor Function Measure Scale
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 value of regional homogeneity (ReHo)
a variable from resting-blood oxygenation level dependent(BOLD)sequence of MRI
mean diffusion(MD)
a variable from Diffusion Tensor Image(DTI) sequence of MRI

Full Information

First Posted
February 22, 2018
Last Updated
March 16, 2023
Sponsor
Children's Hospital of Fudan University
Collaborators
Shanghai 6F+ Early intervention center for high risk preterm infants
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1. Study Identification

Unique Protocol Identification Number
NCT03527498
Brief Title
Evaluation of Long-term Neurodevelopment in Neonatal Encephalopathy by Infant Treadmill
Official Title
A Randomized Clinical Trial of Infant Treadmill for Long-term Neurodevelopmental Evaluation of Neonatal Encephalopathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University
Collaborators
Shanghai 6F+ Early intervention center for high risk preterm infants

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia, Intraventricular Hemorrhage, Bilirubin Encephalopathy, Kernicterus, Hypoglycemia, Neonatal, Cerebral Infarction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All subjects were divided into two groups: intervention group A (treadmill intervention + routine physical rehabilitation therapy) and positive control group (receiving routine physical rehabilitation therapy only).
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
Baby treadmill + physical rehabilitation training
Arm Title
positive control group
Arm Type
Active Comparator
Arm Description
Physical rehabilitation training only
Intervention Type
Device
Intervention Name(s)
Baby treadmill
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical rehabilitation training
Intervention Description
Suitable for general physical rehabilitation training of all infants with cerebral palsy.
Primary Outcome Measure Information:
Title
score from Bayley Scales of Infant and Toddler Development testing
Description
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.
Time Frame
The length of time from birth to the corrected age of 18 months
Title
fractional anisotropy(FA)
Description
a variable from Diffusion Tensor Image(DTI)sequence of MRI
Time Frame
The length of time from birth to the corrected age of 18 months
Title
the value of Amplitude of Low Frequency Fluctuation(ALFF)
Description
a variable from resting-blood oxygenation level dependent(BOLD)sequence of MRI
Time Frame
The length of time from birth to the corrected age of 18 months
Secondary Outcome Measure Information:
Title
Alberta Infant Motor Development Assessment
Description
Neurodevelopmental evaluation scale
Time Frame
The length of time from birth to the corrected age of 18 months
Title
Peabody motor development scale
Description
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).
Time Frame
The length of time from birth to the corrected age of 18 months
Title
Gross Motor Function Measure Scale
Description
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.
Time Frame
The length of time from birth to the corrected age of 18 months
Title
the value of regional homogeneity (ReHo)
Description
a variable from resting-blood oxygenation level dependent(BOLD)sequence of MRI
Time Frame
Corrected age of 18 months
Title
mean diffusion(MD)
Description
a variable from Diffusion Tensor Image(DTI) sequence of MRI
Time Frame
The length of time from birth to the corrected age of 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gestational age < 33 weeks; Correction of gestational age < 3 months; It has been diagnosed as hypoxic-ischemic encephalopathy, periventricular intraventricular hemorrhage, periventricular leukomalacia, bilirubin encephalopathy, persistent hypoglycemia and cerebral infarction. There was no other therapeutic intervention before entering the study; 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: Brain injury caused by central or peripheral infection (cerebrospinal fluid positive / torch test positive / three major conventional culture positive); Brain damage caused by convulsion; Metabolic brain damage caused by genetic defects; Suffering from known severe congenital malformations; Definite head trauma during labor or postpartum; Peripheral neuromuscular disease or abnormal skeletal system.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenhao Zhou, Prof.
Phone
+86-21-64931003
Email
zhwchfu@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kai Yan, Doc.
Phone
+86-21-64931168
Email
fhyankai@163.com
Facility Information:
Facility Name
Children Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenhao Zhou, Doctor
Phone
(+86)021-64931003
Email
zwhchfu@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26828941
Citation
Vasudevan EV, Patrick SK, Yang JF. Gait Transitions in Human Infants: Coping with Extremes of Treadmill Speed. PLoS One. 2016 Feb 1;11(2):e0148124. doi: 10.1371/journal.pone.0148124. eCollection 2016.
Results Reference
background
PubMed Identifier
25782975
Citation
Teulier C, Lee DK, Ulrich BD. Early gait development in human infants: Plasticity and clinical applications. Dev Psychobiol. 2015 May;57(4):447-58. doi: 10.1002/dev.21291. Epub 2015 Mar 18.
Results Reference
background
PubMed Identifier
25644966
Citation
Siekerman K, Barbu-Roth M, Anderson DI, Donnelly A, Goffinet F, Teulier C. Treadmill stimulation improves newborn stepping. Dev Psychobiol. 2015 Mar;57(2):247-54. doi: 10.1002/dev.21270. Epub 2015 Feb 2.
Results Reference
background
PubMed Identifier
25123212
Citation
de Klerk CC, Johnson MH, Heyes CM, Southgate V. Baby steps: investigating the development of perceptual-motor couplings in infancy. Dev Sci. 2015 Mar;18(2):270-80. doi: 10.1111/desc.12226. Epub 2014 Aug 13.
Results Reference
background
PubMed Identifier
24136687
Citation
Madhavan S, Campbell SK, Campise-Luther R, Gaebler-Spira D, Zawacki L, Clark A, Boynewicz K, Kale D, Bulanda M, Yu J, Sui Y, Zhou XJ. Correlation between fractional anisotropy and motor outcomes in one-year-old infants with periventricular brain injury. J Magn Reson Imaging. 2014 Apr;39(4):949-57. doi: 10.1002/jmri.24256. Epub 2013 Oct 17.
Results Reference
background
PubMed Identifier
24012586
Citation
Angulo-Barroso RM, Tiernan C, Chen LC, Valentin-Gudiol M, Ulrich D. Treadmill training in moderate risk preterm infants promotes stepping quality--results of a small randomised controlled trial. Res Dev Disabil. 2013 Nov;34(11):3629-38. doi: 10.1016/j.ridd.2013.07.037. Epub 2013 Sep 4.
Results Reference
background

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

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