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Early Intervention Based on Neonatal Crawling in Very Premature Infants Without Major Brain Damage (Premalocom1)

Primary Purpose

Prematurity

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Crawling stimulation with the crawliskate
Tummy time without the crawliskate
Sponsored by
Marianne Barbu-Roth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prematurity

Eligibility Criteria

37 Weeks - 42 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Term between 24-32 GA
  • parental consent
  • family living in intervention area
  • good tolerance on the first crawliskate trial

Exclusion Criteria:

  • no bronchodysplasia define by oxygen dependency after 36 GA
  • no medical disease
  • no limb deformity
  • no karyotype anomaly
  • no visual or auditory inpairment

Sites / Locations

  • APHP
  • Cnrs Umr 8002

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Crawli Group

Mattress Group

Control Group

Arm Description

Participants from the Crawli Group will benefit from the crawling stimulation intervention with the crawliskate

Participants from the Mattress Group will benefit from the tummy time intervention

Control group infants benefit from usual care.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Amiel-Tison Neurological Assessment
Infant neurological examination at study entry and after the training
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
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.
2D & 3D analysis of movement
2D & 3D analysis of movement (head control, sitting, crawling, stepping, walking) using qualysis and gaitrite system
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.
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.

Full Information

First Posted
February 21, 2022
Last Updated
July 18, 2022
Sponsor
Marianne Barbu-Roth
Collaborators
Ecole Pratique des Hautes Etudes
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1. Study Identification

Unique Protocol Identification Number
NCT05278286
Brief Title
Early Intervention Based on Neonatal Crawling in Very Premature Infants Without Major Brain Damage
Acronym
Premalocom1
Official Title
Effects of Early Crawling Training on the Motor Development of Very Premature Infants Without Major Brain Damage
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 27, 2017 (Actual)
Primary Completion Date
November 15, 2021 (Actual)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marianne Barbu-Roth
Collaborators
Ecole Pratique des Hautes Etudes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Crawli Group
Arm Type
Experimental
Arm Description
Participants from the Crawli Group will benefit from the crawling stimulation intervention with the crawliskate
Arm Title
Mattress Group
Arm Type
Active Comparator
Arm Description
Participants from the Mattress Group will benefit from the tummy time intervention
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control group infants benefit from usual care.
Intervention Type
Behavioral
Intervention Name(s)
Crawling stimulation with the crawliskate
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tummy time without the crawliskate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gross motor score from the Bayley Scale of Infant and toddlers Development III ed.
Description
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.
Time Frame
12 months corrected age
Secondary Outcome Measure Information:
Title
Amiel-Tison Neurological Assessment
Description
Infant neurological examination at study entry and after the training
Time Frame
at 37-41 gestational age, 2, 6, 9, 12, 24 months corrected age
Title
Prechtl assessment
Description
General movements assessment by video recording: measures the fluency and variability of spontaneous movement while the infant is lying supine on a mattress
Time Frame
at 37-41 gestational age and 2 months corrected age
Title
Age and Stage questionnaire (ASQ) 3
Description
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.
Time Frame
2, 6, 9, 12, 18, 24 corrected age and 5 years
Title
2D & 3D analysis of movement
Description
2D & 3D analysis of movement (head control, sitting, crawling, stepping, walking) using qualysis and gaitrite system
Time Frame
at 37-41 gestational age, 2, 6, 9, 12, 24 months corrected age
Title
All scores from the Bayley Scale of Infant and toddlers Development III ed.
Description
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.
Time Frame
24 months corrected age
Title
Fine and gross motor scores from the Bayley Scale of Infant and toddlers Development III ed.
Description
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.
Time Frame
2, 6, 9, 12, 18 months corrected age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
37 Weeks
Maximum Age & Unit of Time
42 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Term between 24-32 GA parental consent family living in intervention area good tolerance on the first crawliskate trial Exclusion Criteria: no bronchodysplasia define by oxygen dependency after 36 GA no medical disease no limb deformity no karyotype anomaly no visual or auditory inpairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Barbu-Roth, PhD
Organizational Affiliation
Centre National de la Recherche Scientifique, France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Valérie Biran, MD, PhD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
APHP
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75019
Country
France
Facility Name
Cnrs Umr 8002
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75006
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be made available upon reasonable request to corresponding author
IPD Sharing Time Frame
From 2025 to 2035
IPD Sharing Access Criteria
IPD will be made available upon reasonable request to corresponding author

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Early Intervention Based on Neonatal Crawling in Very Premature Infants Without Major Brain Damage

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