PrematurityPremalocom1NCT05278286
Early Intervention Based on Neonatal Crawling in Very Premature Infants Without Major Brain Damage
A study testing Crawling stimulation with the crawliskate and Tummy time without the crawliskate in people with Prematurity, run by Marianne Barbu-Roth at 2 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 37 to 42 weeks
- Conditions the study is for
- Prematurity
- What is being tested?
- Crawling stimulation with the crawliskate and Tummy time without the crawliskate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesFrance
- Study dates
- 27 Mar 2017to Nov 2024
- 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 37 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Term between 24-32 GA
- parental consent
- family living in intervention area
- good tolerance on the first crawliskate trial
Who cannot join
- no bronchodysplasia define by oxygen dependency after 36 GA
- no medical disease
- no limb deformity
- no karyotype anomaly
- no visual or auditory inpairment
Trial locations and contacts
2 sites in 1 country.
France2 sites
Cnrs Umr 8002
Paris, Île-de-France Region, 75006
APHP
Paris, Île-de-France Region, 75019
About this study
Official title: Effects of Early Crawling Training on the Motor Development of Very Premature Infants Without Major Brain Damage
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 our previous studies, we discovered that promoting the crawling of typical newborns on a mini skateboard, the Crawliskate (a new tool that we 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 median risk for developmental delay.
Read more
Methodology: We will study and follow three groups of very premature infants born between 24 and 32 weeks of gestational age without 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 physiotherapists to crawl on the Crawliskate every day for 2 months (Crawli group), one group of infants will be trained at home by physiotherapists positioned prone on a mattress (Mattress 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 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 24 months CA (2D and 3D recording of head control, sitting, crawling, stepping, walking) and 3) their neurodevelopmental, motor and neuropsychological development between 0 and 24 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: Our 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 mattress training or no training.
- Conditions
- Prematurity
- Being tested
- Crawling stimulation with the crawliskate, Tummy time without the crawliskate
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crawling stimulation with the crawliskateBehavioural
Consists of 2 months of daily training. Infants benefit from a 5 minutes session everyday at home with a trained therapist. During each session the infant is prone wrapped on the crawliskate and has to produce flexion and extension movements with his four limbs in order to move forward with the assistance of the therapist.
Tummy time without the crawliskateBehavioural
Consists of 2 months of daily training. Infants benefit from a 5-minutes session everyday at home with a trained therapist. During each session the infant is prone directly ona mattress and cannot benefit from any assistance from the therapist to move forward.
| Study group | Role | What they receive |
|---|---|---|
| Crawli Group | Experimental | Participants from the Crawli Group will benefit from the crawling stimulation intervention with the crawliskate Receives: Behavioral: Crawling stimulation with the crawliskate |
| Mattress Group | Active comparator | Participants from the Mattress Group will benefit from the tummy time intervention Receives: Behavioral: Tummy time without 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 (6)
Amiel-Tison Neurological Assessment
Infant neurological examination at study entry and after the training
Measured: at 37-41 gestational age, 2, 6, 9, 12, 24 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 37-41 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, 24 corrected age and 5 years
2D & 3D analysis of movement
2D \& 3D analysis of movement (head control, sitting, crawling, stepping, walking) using qualysis and gaitrite system
Measured: at 37-41 gestational age, 2, 6, 9, 12, 24 months corrected age
All 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 24 months corrected age we evaluate the score from each aspect. 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: 24 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 18 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, 18 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 posted14 Mar 2022
- Study start27 Mar 2017
- Primary completion15 Nov 2021
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marianne Barbu-Roth
- Sponsor type
- University, hospital or other
- Collaborators
- Ecole Pratique des Hautes Etudes
- 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
- NCT05278286
- Sponsor's protocol ID
- Premalocom1
- Other IDs
- ANR-20-CE17-0014
- Acronym
- Premalocom1
- Status last verified
- Jul 2022
- First submitted
- 21 Feb 2022
- Last updated
- 19 Jul 2022
- 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
Publications
Dumuids-Vernet MV, Forma V, Provasi J, Anderson DI, Hinnekens E, Soyez E, Strassel M, Gueret L, Hym C, Huet V, Granjon L, Calamy L, Dassieu G, Boujenah L, Dollat C, Biran V, Barbu-Roth M. Stimulating the motor development of very premature infants: effects of early crawling training on a mini-skateboard. Front Pediatr. 2023 Jun 6;11:1198016. doi: 10.3389/fped.2023.1198016. eCollection 2023.
PubMed 37346892
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Crawling Training on the Motor Development of Very Premature Infants Without Major Brain Damage
- ClinicalTrials.gov ID
- NCT05278286
- Acronym / sponsor ID
- Premalocom1 / Premalocom1
- Conditions
- Prematurity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Marianne Barbu-RothUniversity, hospital or other
- Collaborators
- Ecole Pratique des Hautes Etudes
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- Nov 2024 (estimated)
- First posted
- 14 Mar 2022 (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 our previous studies, we discovered that promoting the crawling of typical newborns on a mini skateboard, the Crawliskate (a new tool that we 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 median risk for developmental delay.
Methodology: We will study and follow three groups of very premature infants born between 24 and 32 weeks of gestational age without 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 physiotherapists to crawl on the Crawliskate every day for 2 months (Crawli group), one group of infants will be trained at home by physiotherapists positioned prone on a mattress (Mattress 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 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 24 months CA (2D and 3D recording of head control, sitting, crawling, stepping, walking) and 3) their neurodevelopmental, motor and neuropsychological development between 0 and 24 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: Our 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 mattress training or no training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Crawli Group | Experimental | Behavioral: Crawling stimulation with the crawliskateParticipants from the Crawli Group will benefit from the crawling stimulation intervention with the crawliskate |
| Mattress Group | Active comparator | Behavioral: Tummy time without the crawliskateParticipants from the Mattress Group will benefit from the tummy time intervention |
| Control Group | No intervention | –Control group infants benefit from usual care. |
Who may qualify
- Ages
- 37 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Term between 24-32 GA
- parental consent
- family living in intervention area
- good tolerance on the first crawliskate trial
Key exclusion criteria (5 listed)
- no bronchodysplasia define by oxygen dependency after 36 GA
- no medical disease
- no limb deformity
- no karyotype anomaly
- no visual or auditory inpairment
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 the crawliskateConsists of 2 months of daily training. Infants benefit from a 5 minutes session everyday at home with a trained therapist. During each session the infant is prone wrapped on the crawliskate and has to produce flexion and extension movements with his four limbs in order to move forward with the assistance of the therapist. | Behavioural | Crawli Group |
| Tummy time without the crawliskateConsists of 2 months of daily training. Infants benefit from a 5-minutes session everyday at home with a trained therapist. During each session the infant is prone directly ona mattress and cannot benefit from any assistance from the therapist to move forward. | Behavioural | Mattress 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.
6 secondary outcomes
Amiel-Tison Neurological Assessment
Time frame: at 37-41 gestational age, 2, 6, 9, 12, 24 months corrected age
Prechtl assessment
Time frame: at 37-41 gestational age and 2 months corrected age
Age and Stage questionnaire (ASQ) 3
Time frame: 2, 6, 9, 12, 18, 24 corrected age and 5 years
2D & 3D analysis of movement
Time frame: at 37-41 gestational age, 2, 6, 9, 12, 24 months corrected age
All scores from the Bayley Scale of Infant and toddlers Development III ed.
Time frame: 24 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, 18 months corrected age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Derived from this study: PubMed 37346892Dumuids-Vernet MV, Forma V, Provasi J, Anderson DI, Hinnekens E, Soyez E, Strassel M, Gueret L, Hym C, Huet V, Granjon L, Calamy L, Dassieu G, Boujenah L, Dollat C, Biran V, Barbu-Roth M. Stimulating the motor development of very premature infants: effects of early crawling training on a mini-skateboard. Front Pediatr. 2023 Jun 6;11:1198016. doi: 10.3389/fped.2023.1198016. eCollection 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. This study is not recruiting at the moment.
Marianne Barbu-Roth, PhD study chair
Centre National de la Recherche Scientifique, France
Valérie Biran, MD, PhD principal investigator
APHP
2 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 the crawliskate and Tummy time without the crawliskate in people with Prematurity, run by Marianne Barbu-Roth at 2 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: status not confirmed, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
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?
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?
On the ClinicalTrials.gov record for NCT05278286, which also lists 1 linked publication.
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 19 Jul 2022.