Psychomotor Therapy for Very Premature Infants (VPI)
Primary Purpose
Premature Infant
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Early post hospital discharge psychomotor therapy
Sponsored by

About this trial
This is an interventional treatment trial for Premature Infant focused on measuring Neuromotor sequelae, Cognitive disorders, Cerebral development, Psychomotoricity, Postural management, Motor coordination, Parenthood
Eligibility Criteria
Inclusion Criteria:
- Infants with a gestational age between 24 and 30 weeks.
Exclusion Criteria:
- Infants with congenital disease,
- Infants with brain bleeding grade III-IV,
- Infants with periventricular leucomalacia,
- Infants whose mothers had a documented history of physical or mental illness, or drug abuse
- Infants from non-French -speaking families.
Sites / Locations
- CH Albi
- CH Auch
- CH Cahors
- CH Castres
- CHIVA centre hospitalier du val d'Ariège
- CH Montauban
- CH Tarbes
- Hôpital des enfants
- Clinique Sarrus Teinturiers
- Clinique Ambroise Paré
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Psychomotor therapy
Control
Arm Description
Early post hospital discharge psychomotor therapy.
No specific support.
Outcomes
Primary Outcome Measures
Psychomotor development assessment.
Assessed by the Bayley Scale Third Edition BSID-III.
Secondary Outcome Measures
The acceptability of the protocol by the parents for the intervention group.
Assessed by a self-questionnaire given by the neonatologist at the end of the treatment.
The quality of parenting.
Assessed by a grid (established by the team of child psychiatry neonatology).
The clinical evolution of the child assessed by a standardized neurological examination.
Assessed during the consultations planned in the network (neonatologists of the CHU), based on a standardized neurological examination.
Full Information
NCT ID
NCT03093337
First Posted
March 14, 2017
Last Updated
May 17, 2023
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT03093337
Brief Title
Psychomotor Therapy for Very Premature Infants
Acronym
VPI
Official Title
Early Post Hospital Discharge Psychomotor Therapy Intervention Program: Effect on the Development in Very Preterm Infants at 2-years Corrected Age
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2007 (Actual)
Primary Completion Date
December 1, 2013 (Actual)
Study Completion Date
July 8, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
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
Our current reflexion is that sensory dys-stimulations, including vestibule-proprioceptive disorders and unbalanced between brain and brainstem maturation of the neonatal period involve an early deviant development for immature infants that will be cascaded through the brain scaffolding and later development. The primary purpose is to determine whether the Early Psychomotor Therapy Intervention Program improves development and behavior in very preterm infants (VPI) at 24-month corrected age (CA).
Detailed Description
VPI < 30 week of amenorrhea were randomized, in a simple blind controlled trial. The psychomotor development was evaluated according to the Bayley Scales of Infant Development-III (BSID-III) at 2 years CA. An intermediate point was provided at 9 months CA. Pediatric standardized assessments and psychologist semi-directive interviews were conducted. Parents also completed a self-administering questionnaire relating to the post-traumatic stress. The intervention consisted on 20 therapy sessions between 2 and 9 months CA, in order to support infants' development, and parent-infant interactions and adjustment.
Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infant
Keywords
Neuromotor sequelae, Cognitive disorders, Cerebral development, Psychomotoricity, Postural management, Motor coordination, Parenthood
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psychomotor therapy
Arm Type
Experimental
Arm Description
Early post hospital discharge psychomotor therapy.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No specific support.
Intervention Type
Other
Intervention Name(s)
Early post hospital discharge psychomotor therapy
Intervention Description
The intervention consisted on 20 psychomotor therapy sessions between 2 and 9 months, in order to support infants' development, and parent-infant interactions and adjustment. The therapy was based on body and emotional positive feelings and experiences, leading to improve sensory motor and perceptive integration, interactive and exploratory behaviors, physiological and tonic-emotional self-regulation, motor organization and early coordination. The intervention was a partnership with the parents, leading to decode the baby needs and expectations, for the parents to experiment more positive feelings, to become more confident in their own skills and more sensitive, and in synchrony with their baby. Intervention was supported by a detailed assessment scale implemented in the regional network related to the follow-up for vulnerable babies.
Primary Outcome Measure Information:
Title
Psychomotor development assessment.
Description
Assessed by the Bayley Scale Third Edition BSID-III.
Time Frame
Year 2
Secondary Outcome Measure Information:
Title
The acceptability of the protocol by the parents for the intervention group.
Description
Assessed by a self-questionnaire given by the neonatologist at the end of the treatment.
Time Frame
Month 9
Title
The quality of parenting.
Description
Assessed by a grid (established by the team of child psychiatry neonatology).
Time Frame
Month 9; Year 2
Title
The clinical evolution of the child assessed by a standardized neurological examination.
Description
Assessed during the consultations planned in the network (neonatologists of the CHU), based on a standardized neurological examination.
Time Frame
Months 3, 6, 9, 12, 18, 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Weeks
Maximum Age & Unit of Time
30 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infants with a gestational age between 24 and 30 weeks.
Exclusion Criteria:
Infants with congenital disease,
Infants with brain bleeding grade III-IV,
Infants with periventricular leucomalacia,
Infants whose mothers had a documented history of physical or mental illness, or drug abuse
Infants from non-French -speaking families.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinne Alberge, MD
Organizational Affiliation
Hôpital des enfants, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Albi
City
Albi
State/Province
Midi-Pyrénées
ZIP/Postal Code
81013
Country
France
Facility Name
CH Auch
City
Auch
State/Province
Midi-Pyrénées
ZIP/Postal Code
32008
Country
France
Facility Name
CH Cahors
City
Cahors
State/Province
Midi-Pyrénées
ZIP/Postal Code
46005
Country
France
Facility Name
CH Castres
City
Castres
State/Province
Midi-Pyrénées
ZIP/Postal Code
81108
Country
France
Facility Name
CHIVA centre hospitalier du val d'Ariège
City
Foix
State/Province
Midi-Pyrénées
ZIP/Postal Code
09017
Country
France
Facility Name
CH Montauban
City
Montauban
State/Province
Midi-Pyrénées
ZIP/Postal Code
82013
Country
France
Facility Name
CH Tarbes
City
Tarbes
State/Province
Midi-Pyrénées
ZIP/Postal Code
65013
Country
France
Facility Name
Hôpital des enfants
City
Toulouse
State/Province
Midi-Pyrénées
ZIP/Postal Code
30159
Country
France
Facility Name
Clinique Sarrus Teinturiers
City
Toulouse
State/Province
Midi-Pyrénées
ZIP/Postal Code
31076
Country
France
Facility Name
Clinique Ambroise Paré
City
Toulouse
State/Province
Midi-Pyrénées
ZIP/Postal Code
31082
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15132247
Citation
Shevell MI, Bodensteiner JB. Cerebral palsy: defining the problem. Semin Pediatr Neurol. 2004 Mar;11(1):2-4. doi: 10.1016/j.spen.2004.01.001.
Results Reference
background
PubMed Identifier
11332166
Citation
Hagberg B, Hagberg G, Beckung E, Uvebrant P. Changing panorama of cerebral palsy in Sweden. VIII. Prevalence and origin in the birth year period 1991-94. Acta Paediatr. 2001 Mar;90(3):271-7.
Results Reference
background
PubMed Identifier
14585946
Citation
Nelson KB. Can we prevent cerebral palsy? N Engl J Med. 2003 Oct 30;349(18):1765-9. doi: 10.1056/NEJMsb035364. No abstract available.
Results Reference
background
PubMed Identifier
15183137
Citation
Jacobsson B, Hagberg G. Antenatal risk factors for cerebral palsy. Best Pract Res Clin Obstet Gynaecol. 2004 Jun;18(3):425-36. doi: 10.1016/j.bpobgyn.2004.02.011.
Results Reference
background
PubMed Identifier
9183258
Citation
Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23. doi: 10.1111/j.1469-8749.1997.tb07414.x.
Results Reference
background
PubMed Identifier
7684346
Citation
Weisglas-Kuperus N, Koot HM, Baerts W, Fetter WP, Sauer PJ. Behaviour problems of very low-birthweight children. Dev Med Child Neurol. 1993 May;35(5):406-16.
Results Reference
background
PubMed Identifier
37191836
Citation
Alberge C, Ehlinger V, Noack N, Bolzoni C, Colombie B, Breinig S, Dicky O, Delobel M, Arnaud C. Early psychomotor therapy in very preterm infants does not improve Bayley-III scales at 2 years. Acta Paediatr. 2023 Sep;112(9):1916-1925. doi: 10.1111/apa.16848. Epub 2023 Jun 5.
Results Reference
result
Learn more about this trial
Psychomotor Therapy for Very Premature Infants
We'll reach out to this number within 24 hrs