Hypoxic-Ischemic EncephalopathyNCT03527498
Evaluation of Long-term Neurodevelopment in Neonatal Encephalopathy by Infant Treadmill
A study testing Baby treadmill and Physical rehabilitation training in people with Hypoxic-Ischemic Encephalopathy and Periventricular Leukomalacia, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 months
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia, Intraventricular Hemorrhage
- What is being tested?
- Baby treadmill and Physical rehabilitation training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Children Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: A Randomized Clinical Trial of Infant Treadmill for Long-term Neurodevelopmental Evaluation of Neonatal Encephalopathy
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.
Read the 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.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia, Intraventricular Hemorrhage, Bilirubin Encephalopathy, Kernicterus, Hypoglycemia, Neonatal
- Being tested
- Baby treadmill, Physical rehabilitation training
- Medical subject headings
- Hypoxia-Ischemia, Brain, Leukomalacia, Periventricular, Kernicterus, Hypoglycemia, Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby treadmillDevice
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.
Physical rehabilitation trainingBehavioural
Suitable for general physical rehabilitation training of all infants with cerebral palsy.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Baby treadmill + physical rehabilitation training Receives: Device: Baby treadmill; Behavioral: Physical rehabilitation training |
| positive control group | Active comparator | Physical rehabilitation training only Receives: Behavioral: Physical rehabilitation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: The length of time from birth to the corrected age of 18 months
Secondary outcomes (5)
Alberta Infant Motor Development Assessment
Neurodevelopmental evaluation scale
Measured: The length of time from birth to the corrected age of 18 months
Peabody motor development scale
The Peabody Developmental Motor Scales (PDMS) is composed of six subtests that measure interrelated abilities in early motor development. It was designed to assess gross and fine motor skills in children from birth through five years of age. Reflexes (Re), Stationary (St), Locomotion (Lo) , Object Manipulation (Ob), Grasping (Gr), Visual-Motor Integration (Vi). All of the PDMS-2 subtests contribute to a Total Motor Quotient (TMQ).
Measured: The length of time from birth to the corrected age of 18 months
Gross Motor Function Measure Scale
There is a 4-point scoring system for each item on the GMFM. Specific descriptors for scoring items are detailed in the administration and scoring guidelines. The GMFM-66 requires a user-friendly computer programme called the Gross Motor Ability Estimator, or GMAE, to enter individual item scores and convert them to an interval level total score.
Measured: The length of time from birth to the corrected age of 18 months
the value of regional homogeneity (ReHo)
a variable from resting-blood oxygenation level dependent（BOLD）sequence of MRI
Measured: Corrected age of 18 months
mean diffusion(MD)
a variable from Diffusion Tensor Image（DTI） sequence of MRI
Measured: The length of time from birth to the corrected age of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start1 Dec 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: The other study was concluded as planned upon reaching its predetermined endpoint, which included the completion of data collection and achievement of the necessary sample size for statistical significance.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 6F+ Early intervention center for high risk preterm infants
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527498
- Sponsor's protocol ID
- CHFudanU_NNICU8
- Status last verified
- Dec 2023
- First submitted
- 22 Feb 2018
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26828941Teulier 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.
PubMed 25782975Siekerman 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.
PubMed 25644966de 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.
PubMed 25123212Madhavan 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.
PubMed 24136687Angulo-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.
PubMed 24012586
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Infant Treadmill for Long-term Neurodevelopmental Evaluation of Neonatal Encephalopathy
- ClinicalTrials.gov ID
- NCT03527498
- Acronym / sponsor ID
- CHFudanU_NNICU8
- Conditions
- Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia, Intraventricular Hemorrhage, Bilirubin Encephalopathy, Kernicterus, Hypoglycemia, Neonatal
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The other study was concluded as planned upon reaching its predetermined endpoint, which included the completion of data collection and achievement of the necessary sample size for statistical significance.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai 6F+ Early intervention center for high risk preterm infants
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Device: Baby treadmill, Behavioral: Physical rehabilitation trainingBaby treadmill + physical rehabilitation training |
| positive control group | Active comparator | Behavioral: Physical rehabilitation trainingPhysical rehabilitation training only |
Who may qualify
- Ages
- 3 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baby treadmillThe 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. | Device | intervention group |
| Physical rehabilitation trainingSuitable for general physical rehabilitation training of all infants with cerebral palsy. | Behavioural | intervention group, positive control group |
Primary outcome
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.
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
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
5 secondary outcomes
Alberta Infant Motor Development Assessment
Time frame: The length of time from birth to the corrected age of 18 months
Peabody motor development scale
Time frame: The length of time from birth to the corrected age of 18 months
Gross Motor Function Measure Scale
Time frame: The length of time from birth to the corrected age of 18 months
the value of regional homogeneity (ReHo)
Time frame: Corrected age of 18 months
mean diffusion(MD)
Time frame: The length of time from birth to the corrected age of 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Background: PubMed 26828941Vasudevan 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.
- Background: PubMed 25782975Teulier 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.
- Background: PubMed 25644966Siekerman 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.
- Background: PubMed 25123212de 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.
- Background: PubMed 24136687Madhavan 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.
- Background: PubMed 24012586Angulo-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby treadmill and Physical rehabilitation training in people with Hypoxic-Ischemic Encephalopathy and Periventricular Leukomalacia, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03527498, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.