Psychomotor Therapy for Very Premature Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Post Hospital Discharge Psychomotor Therapy Intervention Program: Effect on the Development in Very Preterm Infants at 2-years Corrected Age

Conditions
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Premature Infant

Intervention / Treatment
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* Other: Early post hospital discharge psychomotor therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 24 Weeks
Maximum Age: 30 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychomotor therapy<br>Early post hospital discharge psychomotor therapy. | Other: Early post hospital discharge psychomotor therapy<br>* 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.<br>|
| No Intervention: Control<br>No specific support. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychomotor development assessment. | Assessed by the Bayley Scale Third Edition BSID-III. | Year 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Month 9 | 
| The quality of parenting. | Assessed by a grid (established by the team of child psychiatry neonatology). | Month 9; Year 2 | 
| 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. | Months 3, 6, 9, 12, 18, 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuromotor sequelae, Cognitive disorders, Cerebral development, Psychomotoricity, Postural management, Motor coordination, Parenthood