Psychomotor Therapy for Very Premature Infants (VPI)

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

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).

Study Overview

• Status: Completed
• Conditions: Premature Infant
• Intervention / Treatment: Other: Early post hospital discharge psychomotor therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Midi-Pyrénées
    • Albi, Midi-Pyrénées, France, 81013
      • CH ALBI
    • Auch, Midi-Pyrénées, France, 32008
      • CH Auch
    • Cahors, Midi-Pyrénées, France, 46005
      • CH Cahors
    • Castres, Midi-Pyrénées, France, 81108
      • Ch Castres
    • Foix, Midi-Pyrénées, France, 09017
      • CHIVA centre hospitalier du val d'Ariège
    • Montauban, Midi-Pyrénées, France, 82013
      • CH Montauban
    • Tarbes, Midi-Pyrénées, France, 65013
      • CH Tarbes
    • Toulouse, Midi-Pyrénées, France, 30159
      • Hopital des Enfants
    • Toulouse, Midi-Pyrénées, France, 31076
      • Clinique Sarrus Teinturiers
    • Toulouse, Midi-Pyrénées, France, 31082
      • Clinique Ambroise Pare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 2 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Psychomotor therapy; Early post hospital discharge psychomotor therapy.	Other: Early post hospital discharge psychomotor therapy; 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.
No Intervention: Control; No specific support.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Corinne Alberge, MD, Hôpital des enfants, Toulouse

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2007
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): July 8, 2017

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (Actual): March 28, 2017

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cognitive disorders; Motor coordination; Parenthood; Neuromotor sequelae; Cerebral development; Psychomotoricity; Postural management
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Neurocognitive Disorders; Cognition Disorders; Premature Birth; Cognitive Dysfunction
• Other Study ID Numbers: 07 227 01; 2007-A00997-46 (Other Identifier: French ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No