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

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.

Conditions

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

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.

Sponsors & Collaborators

• Shanghai 6F+ Early intervention center for high risk preterm infants

  collaborator UNKNOWN

• Children's Hospital of Fudan University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

3 Months

Max Age

18 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-01

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• China

Study Locations