Psychomotor Therapy for Very Premature Infants

Not Applicable

Completed

• Conditions: Premature Infant
• Interventions: Other: Early post hospital discharge psychomotor therapy

• Registration Number: NCT03093337
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study Start: 2007-12-01
• Primary Completion: 2013-12-01
• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-28
• Study Completion: 2017-07-08
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychomotor therapy	Early post hospital discharge psychomotor therapy	Early post hospital discharge psychomotor therapy.

Primary Outcome Measures

Name	Time	Method
Psychomotor development assessment.	Year 2	Assessed by the Bayley Scale Third Edition BSID-III.

Secondary Outcome Measures

Name	Time	Method
The acceptability of the protocol by the parents for the intervention group.	Month 9	Assessed by a self-questionnaire given by the neonatologist at the end of the treatment.
The clinical evolution of the child assessed by a standardized neurological examination.	Months 3, 6, 9, 12, 18, 24	Assessed during the consultations planned in the network (neonatologists of the CHU), based on a standardized neurological examination.
The quality of parenting.	Month 9; Year 2	Assessed by a grid (established by the team of child psychiatry neonatology).

Trial Locations

Locations (10)

CH Castres; 🇫🇷 Castres, Midi-Pyrénées, France

CH Cahors; 🇫🇷 Cahors, Midi-Pyrénées, France

CH Albi; 🇫🇷 Albi, Midi-Pyrénées, France

CH Montauban; 🇫🇷 Montauban, Midi-Pyrénées, France

CH Auch; 🇫🇷 Auch, Midi-Pyrénées, France

CHIVA centre hospitalier du val d'Ariège; 🇫🇷 Foix, Midi-Pyrénées, France

Hôpital des enfants; 🇫🇷 Toulouse, Midi-Pyrénées, France

Clinique Ambroise Paré; 🇫🇷 Toulouse, Midi-Pyrénées, France

CH Tarbes; 🇫🇷 Tarbes, Midi-Pyrénées, France

Clinique Sarrus Teinturiers; 🇫🇷 Toulouse, Midi-Pyrénées, France