PrematurityPremalocom2NCT06027645
Early Intervention Based on Neonatal Crawling in Very Premature Infants at Risk For Neurodevelopmental Disorder
A study testing Crawling stimulation with a mini-skateboard (i.e. the crawliskate) in people with Prematurity and Extreme Prematurity, run by Marianne Barbu-Roth at 3 sites in France.
Trial summary
Extreme prematurity is constantly increasing according to the World Health Organization. However, methods to train premature infants at risk of disability is sorely lacking. The goal of this project is to overcome this problem. Read more about this study
- Who is it for?
- Ages 39 to 42 weeks
- Conditions the study is for
- Prematurity, Extreme Prematurity, Infant Development
- What is being tested?
- Crawling stimulation with a mini-skateboard (i.e. the crawliskate)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesFrance
- Study dates
- 29 Mar 2021to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 39 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Term between 24-26 GA or 26-32 GA with suspected brain lesion
- parental consent
- family living in intervention area
- good tolerance on the first crawliskate trial
Who cannot join
- no bronchodysplasia defined by oxygen dependency after 36 GA
- no medical disease
- no limb deformity
- no karyotype anomaly
- no visual or auditory impairment
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Hôpital Paris Saint-Joseph
Paris, 75014
Laurence Boujenah, MD, lboujenah@ghpsj.fr
- Recruiting
Cnrs Umr 8002
Paris, Île-de-France Region, 75006
Marianne Barbu-Roth, PhD, 0033618610915, barburoth@gmail.com
Elodie Hinnekens, PT, PhD, 0033631752420, elodie.hinnekens@gmail.com
- Recruiting
Hôpital Robert Debré
Paris, Île-de-France Region, 75019
Valérie Biran, MD, PhD, 00336 88 48 48 85, valerie.biran@aphp.fr
About this study
Official title: Effects of Early Crawling Training Via a Mini-Skateboard on the Motor Development of Very Premature Infants at Risk For Neurodevelopmental Disorder
Extreme prematurity is constantly increasing according to the World Health Organization. However, methods to train premature infants at risk of disability is sorely lacking. The goal of this project is to overcome this problem. In previous studies, the investigators discovered that promoting the crawling of typical newborns on a mini skateboard, the Crawliskate (a new tool that the investigators designed and patented EP2974624A1), is an excellent way to stimulate infants' motor and locomotor development. This method is a promising way to provide early interventions in infants at heightened risk for developmental delay, such as premature infants.
The specific objective of this study is to determine if early training in crawling on this mini skateboard will accelerate motor (particularly locomotor) and/or neuropsychological development in very premature infants identified as high risk for developmental delay.
Read more
Methodology: The investigators will study and follow two groups of very premature infants born between 24 and 26 weeks of gestational age or born between 26 and 32 with major brain lesions.
These infants will be recruited before their hospital discharge at the NICU. After their discharge from the hospital, one group of infants will be trained at home by their parents under the supervision of physiotherapists to crawl on the Crawliskate every day for 2 months (Crawli group), and one group of infants will receive regular medical care (Control group). All infants will be tested for: 1)their crawling proficiency on the Crawliskate at term-equivalent age (just before training for the trained groups) and at 2 and 6 months corrected age (CA, i.e., age determined from the date on which they should have been born), 2) their motor proficiency between 2 and 12 months CA (2D and 3D recording of head control, sitting, crawling, stepping, walking) and 3) their neurodevelopmental, motor and neuropsychological development between 0 and 28 months CA: BSID III edition, ASQ-3, Amiel-Tison's Neurological Assessment, Prechtl Assessment of general movements. One more ASQ-3 questionnaire will be provided at five years.
Expected results: The first research hypothesis is that premature infants trained daily to crawl (for two months after discharge from the NICU) will acquire proficient crawling patterns and develop earlier and more effective motor and neuropsychological development than premature infants who receive no training.
- Conditions
- Prematurity, Extreme Prematurity, Infant Development, Brain Damage, Motor and Developmental Delay
- Being tested
- Crawling stimulation with a mini-skateboard (i.e. the crawliskate)
- Keywords
- Prematurity, Crawling, Early intervention, Motor development, Locomotion
- Medical subject headings
- Premature Birth, Brain Injuries, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crawling stimulation with a mini-skateboard (i.e. the crawliskate)Behavioural
Consists of 8 weeks of daily training. Infants benefit from a 10 minutes session everyday at home with either a trained therapist or his/her parents. Parents are trained by the therapist at the begining of the 8 weeks. During each session the infant is prone wrapped on a mini-skateboard (i.e. the crawliskate) and has to produce flexion and extension movements with his four limbs in order to move forward with the assistance of the adult (therapist or parent).
| Study group | Role | What they receive |
|---|---|---|
| Crawli Group | Experimental | Participants from the Crawli Group will benefit from the crawling stimulation intervention with a mini-skateboard (i.e. the crawliskate) in addition to usual care Receives: Behavioral: Crawling stimulation with a mini-skateboard (i.e. the crawliskate) |
| Control Group | No intervention | Control group infants benefit from usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross motor score from the Bayley Scale of Infant and toddlers Development III ed.
The Bayley Scale of Infant and toddlers Development III ed. (BSID III) assesses several aspect of development: motor, fine motor, communication, personal social, language and problem solving domain.
A score can be obtained for each aspect. At 12 months corrected age we only evaluate gross and fine motor scores, and we consider the gross motor score obtained at 12 months corrected age as the primary outcome of our study.
The minimal score is 0 and there is no maximal score (the child is asked to complete several tasks, and the test can continues with questions from an upper age and only stops when a child no longer succeed with the tasks to complete). A higher score means more advanced skills.
Measured: 12 months corrected age
Secondary outcomes (5)
Amiel-Tison Neurological Assessment
Infant neurological examination at study entry and after the training
Measured: at 39-42 gestational age, 2, 9, 12 months corrected age
Prechtl assessment
General movements assessment by video recording: measures the fluency and variability of spontaneous movement while the infant is lying supine on a mattress
Measured: at 39-42 gestational age and 2 months corrected age
Age and Stage questionnaire (ASQ) 3
Parental appreciation of their infant development in personal-social, communication, gross motor, fine motor and problem solving domain The minimal score is 0 and the maximal score is 60. A higher score means more advanced skills.
Measured: 2, 6, 9, 12, 18, 28 corrected age and 5 years
2D & 3D analysis of movement
2D \& 3D analysis of movement (head control, sitting, crawling, stepping, walking) using a motion capture system.
Measured: at 39-42 gestational age, 2, 6, 9, 12 months corrected age
Fine and gross motor scores from the Bayley Scale of Infant and toddlers development III ed.
The Bayley Scale of Infant and toddlers Development III ed. (BSID III) assesses several aspect of development: motor, fine motor, communication, personal social, language and problem solving domain.
A score can be obtained for each aspect. At 2, 6, 9, 12 and 24 months corrected age we only evaluate fine and gross motor scores. Note that the gross motor score obtained at 12 months corrected age is the primary outcome of our study but the fine motor score obtained at 12 months corrected age is also a secondary outcome.
The minimal score is 0 and there is no maximal score (the child is asked to complete several tasks, and the test can continues with questions from an upper age and only stops when a child no longer succeed with the tasks to complete). A higher score means more advanced skills.
Measured: 2, 6, 9, 12, 24 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start29 Mar 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marianne Barbu-Roth
- Sponsor type
- University, hospital or other
- Collaborators
- Ecole Pratique des Hautes Etudes, Université Paris Cité, San Francisco State University, Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor-investigator, Marianne Barbu-Roth, Centre National de la Recherche Scientifique, France
- Investigators
- Marianne Barbu-Roth, PhD, Study chair, Centre National de la Recherche Scientifique, FranceValérie Biran, MD, PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027645
- Sponsor's protocol ID
- Premalocom2
- Acronym
- Premalocom2
- Status last verified
- Sep 2023
- First submitted
- 31 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be made available upon reasonable request to corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Crawling Training Via a Mini-Skateboard on the Motor Development of Very Premature Infants at Risk For Neurodevelopmental Disorder
- ClinicalTrials.gov ID
- NCT06027645
- Acronym / sponsor ID
- Premalocom2 / Premalocom2
- Conditions
- Prematurity, Extreme Prematurity, Infant Development, Brain Damage, Motor and Developmental Delay
- Keywords
- Prematurity, Crawling, Early intervention, Motor development, Locomotion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Marianne Barbu-RothUniversity, hospital or other
- Collaborators
- Ecole Pratique des Hautes Etudes, Université Paris Cité, San Francisco State University, Assistance Publique - Hôpitaux de Paris
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 7 Sep 2023 (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.
Extreme prematurity is constantly increasing according to the World Health Organization. However, methods to train premature infants at risk of disability is sorely lacking. The goal of this project is to overcome this problem. In previous studies, the investigators discovered that promoting the crawling of typical newborns on a mini skateboard, the Crawliskate (a new tool that the investigators designed and patented EP2974624A1), is an excellent way to stimulate infants' motor and locomotor development. This method is a promising way to provide early interventions in infants at heightened risk for developmental delay, such as premature infants.
The specific objective of this study is to determine if early training in crawling on this mini skateboard will accelerate motor (particularly locomotor) and/or neuropsychological development in very premature infants identified as high risk for developmental delay.
Methodology: The investigators will study and follow two groups of very premature infants born between 24 and 26 weeks of gestational age or born between 26 and 32 with major brain lesions.
These infants will be recruited before their hospital discharge at the NICU. After their discharge from the hospital, one group of infants will be trained at home by their parents under the supervision of physiotherapists to crawl on the Crawliskate every day for 2 months (Crawli group), and one group of infants will receive regular medical care (Control group). All infants will be tested for: 1)their crawling proficiency on the Crawliskate at term-equivalent age (just before training for the trained groups) and at 2 and 6 months corrected age (CA, i.e., age determined from the date on which they should have been born), 2) their motor proficiency between 2 and 12 months CA (2D and 3D recording of head control, sitting, crawling, stepping, walking) and 3) their neurodevelopmental, motor and neuropsychological development between 0 and 28 months CA: BSID III edition, ASQ-3, Amiel-Tison's Neurological Assessment, Prechtl Assessment of general movements. One more ASQ-3 questionnaire will be provided at five years.
Expected results: The first research hypothesis is that premature infants trained daily to crawl (for two months after discharge from the NICU) will acquire proficient crawling patterns and develop earlier and more effective motor and neuropsychological development than premature infants who receive no training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crawli Group | Experimental | Behavioral: Crawling stimulation with a mini-skateboard (i.e. the crawliskate)Participants from the Crawli Group will benefit from the crawling stimulation intervention with a mini-skateboard (i.e. the crawliskate) in addition to usual care |
| Control Group | No intervention | –Control group infants benefit from usual care |
Who may qualify
- Ages
- 39 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Term between 24-26 GA or 26-32 GA with suspected brain lesion
- parental consent
- family living in intervention area
- good tolerance on the first crawliskate trial
Key exclusion criteria (5 listed)
- no bronchodysplasia defined by oxygen dependency after 36 GA
- no medical disease
- no limb deformity
- no karyotype anomaly
- no visual or auditory impairment
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 |
|---|---|---|
| Crawling stimulation with a mini-skateboard (i.e. the crawliskate)Consists of 8 weeks of daily training. Infants benefit from a 10 minutes session everyday at home with either a trained therapist or his/her parents. Parents are trained by the therapist at the begining of the 8 weeks. During each session the infant is prone wrapped on a mini-skateboard (i.e. the crawliskate) and has to produce flexion and extension movements with his four limbs in order to move forward with the assistance of the adult (therapist or parent). | Behavioural | Crawli Group |
Primary outcome
Gross motor score from the Bayley Scale of Infant and toddlers Development III ed.
Time frame: 12 months corrected age
The Bayley Scale of Infant and toddlers Development III ed. (BSID III) assesses several aspect of development: motor, fine motor, communication, personal social, language and problem solving domain. A score can be obtained for each aspect. At 12 months corrected age we only evaluate gross and fine motor scores, and we consider the gross motor score obtained at 12 months corrected age as the primary outcome of our study. The minimal score is 0 and there is no maximal score (the child is asked to complete several tasks, and the test can continues with questions from an upper age and only stops when a child no longer succeed with the tasks to complete). A higher score means more advanced skills.
5 secondary outcomes
Amiel-Tison Neurological Assessment
Time frame: at 39-42 gestational age, 2, 9, 12 months corrected age
Prechtl assessment
Time frame: at 39-42 gestational age and 2 months corrected age
Age and Stage questionnaire (ASQ) 3
Time frame: 2, 6, 9, 12, 18, 28 corrected age and 5 years
2D & 3D analysis of movement
Time frame: at 39-42 gestational age, 2, 6, 9, 12 months corrected age
Fine and gross motor scores from the Bayley Scale of Infant and toddlers development III ed.
Time frame: 2, 6, 9, 12, 24 months corrected age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: Yes. IPD will be made available upon reasonable request to corresponding author
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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.
Marianne Barbu-Roth, PhD study chair
Centre National de la Recherche Scientifique, France
Valérie Biran, MD, PhD principal investigator
APHP
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crawling stimulation with a mini-skateboard (i.e. the crawliskate) in people with Prematurity and Extreme Prematurity, run by Marianne Barbu-Roth at 3 sites in France.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marianne Barbu-Roth, PhD (00336 18 61 09 15, barburoth@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross motor score from the Bayley Scale of Infant and toddlers Development III ed. (time frame: 12 months corrected age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2023.