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

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ClinicalTrials.gov Identifier: NCT03527498
Recruitment Status : Not yet recruiting
First Posted : May 17, 2018
Last Update Posted : May 17, 2018
Sponsor:
Collaborator:
Shanghai 6F+ Early intervention center for high risk preterm infants
Information provided by (Responsible Party):
Children's Hospital of Fudan University

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 Not Applicable

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  (Clinical Trial)
Estimated 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).
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
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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.




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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 Outcome Measures :
  1. Alberta Infant Motor Development Assessment [ Time Frame: The length of time from birth to the corrected age of 18 months ]
    Neurodevelopmental evaluation scale

  2. Peabody motor development scale [ Time Frame: The length of time from birth to the corrected age of 18 months ]
    Neurodevelopmental evaluation scale

  3. Gross Motor Function Measure Scale [ Time Frame: The length of time from birth to the corrected age of 18 months ]
    Neurodevelopmental evaluation scale

  4. 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

  5. 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



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Ages Eligible for Study:   3 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527498


Contacts
Contact: Wenhao Zhou, Prof. +86-21-64931003 zhwchfu@126.com
Contact: Kai Yan, Doc. +86-21-64931168 fhyankai@163.com

Locations
China, Shanghai
Children Hospital of Fudan University
Shanghai, Shanghai, China, 201102
Sponsors and Collaborators
Children's Hospital of Fudan University
Shanghai 6F+ Early intervention center for high risk preterm infants

Publications:
Responsible Party: Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT03527498     History of Changes
Other Study ID Numbers: CHFudanU_NNICU8
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Kernicterus
Infarction
Hemorrhage
Hypoglycemia
Brain Diseases
Cerebral Infarction
Brain Ischemia
Hypoxia-Ischemia, Brain
Cerebral Hemorrhage
Leukomalacia, Periventricular
Ischemia
Pathologic Processes
Necrosis
Glucose Metabolism Disorders
Metabolic Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Cerebrovascular Disorders
Stroke
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain
Intracranial Hemorrhages
Encephalomalacia
Infant, Premature, Diseases
Infant, Newborn, Diseases
Brain Diseases, Metabolic
Erythroblastosis, Fetal
Hematologic Diseases