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

Overview

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.

Full Title of Study: “A Randomized Clinical Trial of Infant Treadmill for Long-term Neurodevelopmental Evaluation of Neonatal Encephalopathy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2022

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: intervention group
    • Baby treadmill + physical rehabilitation training
  • Active Comparator: positive control group
    • Physical rehabilitation training only

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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 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

Secondary Measures

  • Alberta Infant Motor Development Assessment
    • Time Frame: The length of time from birth to the corrected age of 18 months
    • Neurodevelopmental evaluation scale
  • 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).
  • 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 value of regional homogeneity (ReHo)
    • Time Frame: Corrected age of 18 months
    • a variable from resting-blood oxygenation level dependent(BOLD)sequence of MRI
  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 3 Months

Maximum Age: 18 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Children’s Hospital of Fudan University
  • Collaborator
    • Shanghai 6F+ Early intervention center for high risk preterm infants
  • Provider of Information About this Clinical Study
    • Sponsor

References

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.

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.

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.

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.

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.

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.

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