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

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Fudan University

Status

Withdrawn

Conditions

Hypoglycemia, Neonatal
Cerebral Infarction
Intraventricular Hemorrhage
Kernicterus
Periventricular Leukomalacia
Bilirubin Encephalopathy
Hypoxic-Ischemic Encephalopathy

Treatments

Behavioral: Physical rehabilitation training
Device: Baby treadmill

Study type

Interventional

Funder types

Other

Identifiers

NCT03527498
CHFudanU_NNICU8

Details and patient eligibility

About

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 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.

Sex

All

Ages

3 to 18 months old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

0 participants in 2 patient groups

intervention group
Experimental group
Description:
Baby treadmill + physical rehabilitation training
Treatment:
Device: Baby treadmill
Behavioral: Physical rehabilitation training
positive control group
Active Comparator group
Description:
Physical rehabilitation training only
Treatment:
Behavioral: Physical rehabilitation training

Trial contacts and locations

1

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Central trial contact

Kai Yan, Doc.; Wenhao Zhou, Prof.

Data sourced from clinicaltrials.gov

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