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

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Status: Withdrawn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

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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