Psychomotor Therapy for Very Premature Infants

NCT03093337 | Completed

• 1 other identifier: 07 227 01
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 10

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).

Conditions

Premature Infant

Keywords

Neuromotor sequelae; Cognitive disorders; Cerebral development; Psychomotoricity; Postural management; Motor coordination; Parenthood

Outcome Measures

Primary Outcomes (1)

• Psychomotor development assessment.

  Assessed by the Bayley Scale Third Edition BSID-III.

  Year 2

Secondary Outcomes (3)

• The acceptability of the protocol by the parents for the intervention group.

  Month 9

• The quality of parenting.

  Month 9; Year 2

• The clinical evolution of the child assessed by a standardized neurological examination.

  Months 3, 6, 9, 12, 18, 24

Study Arms (2)

Psychomotor therapy

EXPERIMENTAL

Early post hospital discharge psychomotor therapy.

Other: Early post hospital discharge psychomotor therapy

Control

NO INTERVENTION

No specific support.

Interventions

Early post hospital discharge psychomotor therapy OTHER

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.

Psychomotor therapy

Eligibility Criteria

• Age: 24 Weeks - 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants with a gestational age between 24 and 30 weeks.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (10)

CH Albi

Albi, Midi-Pyrénées, 81013, France

Location

CH Auch

Auch, Midi-Pyrénées, 32008, France

Location

CH Cahors

Cahors, Midi-Pyrénées, 46005, France

Location

CH Castres

Castres, Midi-Pyrénées, 81108, France

Location

CHIVA centre hospitalier du val d'Ariège

Foix, Midi-Pyrénées, 09017, France

Location

CH Montauban

Montauban, Midi-Pyrénées, 82013, France

Location

CH Tarbes

Tarbes, Midi-Pyrénées, 65013, France

Location

Hôpital des enfants

Toulouse, Midi-Pyrénées, 30159, France

Location

Clinique Sarrus Teinturiers

Toulouse, Midi-Pyrénées, 31076, France

Location

Clinique Ambroise Paré

Toulouse, Midi-Pyrénées, 31082, France

Location

Related Publications (7)

• 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.

  PMID: 15132247 BACKGROUND

• 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.

  PMID: 11332166 BACKGROUND

• 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.

  PMID: 14585946 BACKGROUND

• 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.

  PMID: 15183137 BACKGROUND

• 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.

  PMID: 9183258 BACKGROUND

• 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.

  PMID: 7684346 BACKGROUND

• 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.

  PMID: 37191836 RESULT

MeSH Terms

Conditions

Premature Birth; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Corinne Alberge, MD

  Hôpital des enfants, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 28, 2017
• Study Start: December 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: July 8, 2017
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)