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

Sponsor

Children's Hospital of Fudan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03527498

Collaborator

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

120

Enrollment

Location

Arms

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypoxic-Ischemic Encephalopathy Periventricular Leukomalacia Intraventricular Hemorrhage Bilirubin Encephalopathy Kernicterus Hypoglycemia, Neonatal Cerebral Infarction	Device: Baby treadmill Behavioral: Physical rehabilitation training	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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).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:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

score from Bayley Scales of Infant and Toddler Development testing [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.
fractional anisotropy(FA) [The length of time from birth to the corrected age of 18 months]
a variable from Diffusion Tensor Image（DTI）sequence of MRI
the value of Amplitude of Low Frequency Fluctuation(ALFF) [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

Secondary Outcome Measures

Alberta Infant Motor Development Assessment [The length of time from birth to the corrected age of 18 months]
Neurodevelopmental evaluation scale
Peabody motor development scale [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).
Gross Motor Function Measure Scale [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 value of regional homogeneity (ReHo) [Corrected age of 18 months]
a variable from resting-blood oxygenation level dependent（BOLD）sequence of MRI
mean diffusion(MD) [The length of time from birth to the corrected age of 18 months]
a variable from Diffusion Tensor Image（DTI） sequence of MRI

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 18 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.