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

NCT03527498 | Withdrawn DMC

• 1 other identifier: CHFudanU_NNICU8
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• score from Bayley Scales of Infant and Toddler Development testing

  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.

  The length of time from birth to the corrected age of 18 months

• fractional anisotropy(FA)

  a variable from Diffusion Tensor Image（DTI）sequence of MRI

  The length of time from birth to the corrected age of 18 months

• the value of Amplitude of Low Frequency Fluctuation(ALFF)

  a variable from resting-blood oxygenation level dependent（BOLD）sequence of MRI

  The length of time from birth to the corrected age of 18 months

Secondary Outcomes (5)

• Alberta Infant Motor Development Assessment

  The length of time from birth to the corrected age of 18 months

• Peabody motor development scale

  The length of time from birth to the corrected age of 18 months

• Gross Motor Function Measure Scale

  The length of time from birth to the corrected age of 18 months

• the value of regional homogeneity (ReHo)

  Corrected age of 18 months

• mean diffusion(MD)

  The length of time from birth to the corrected age of 18 months

Study Arms (2)

intervention group

EXPERIMENTAL

Baby treadmill + physical rehabilitation training

Device: Baby treadmill; Behavioral: Physical rehabilitation training

positive control group

ACTIVE COMPARATOR

Physical rehabilitation training only

Behavioral: Physical rehabilitation training

Interventions

Baby treadmill DEVICE

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.

intervention group

Physical rehabilitation training BEHAVIORAL

Suitable for general physical rehabilitation training of all infants with cerebral palsy.

intervention group; positive control group

Eligibility Criteria

• Age: 3 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age \< 33 weeks;
• Correction of gestational age \< 3 months;
• It has been diagnosed as hypoxic-ischemic encephalopathy, periventricular intraventricular hemorrhage, periventricular leukomalacia, bilirubin encephalopathy, persistent hypoglycemia and cerebral infarction.
• There was no other therapeutic intervention before entering the study;
• Informed consent is signed by the family.

You may not qualify if:

• This study is excluded from the study provided that one of the following conditions is met:
• Brain injury caused by central or peripheral infection (cerebrospinal fluid positive / torch test positive / three major conventional culture positive);
• Brain damage caused by convulsion;
• Metabolic brain damage caused by genetic defects;
• Suffering from known severe congenital malformations;
• Definite head trauma during labor or postpartum;
• Peripheral neuromuscular disease or abnormal skeletal system.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• Shanghai 6F+ Early intervention center for high risk preterm infants: collaborator

Study Sites (1)

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (6)

• 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.

  PMID: 26828941 BACKGROUND

• 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.

  PMID: 25782975 BACKGROUND

• 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.

  PMID: 25644966 BACKGROUND

• 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.

  PMID: 25123212 BACKGROUND

• 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.

  PMID: 24136687 BACKGROUND

• 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.

  PMID: 24012586 BACKGROUND

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Leukomalacia, Periventricular; Kernicterus; Hypoglycemia; Cerebral Infarction

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Encephalomalacia; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Brain Diseases, Metabolic; Erythroblastosis, Fetal; Hematologic Diseases; Hemic and Lymphatic Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Immune System Diseases; Hyperbilirubinemia; Pathologic Processes; Glucose Metabolism Disorders; Brain Infarction; Stroke; Infarction; Ischemia; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: May 17, 2018
• Study Start: December 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)