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Trial record 42 of 1508 for:    child psychiatry

Psychomotor Therapy for Very Premature Infants (VPI)

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ClinicalTrials.gov Identifier: NCT03093337
Recruitment Status : Completed
First Posted : March 28, 2017
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Premature Infant Other: Early post hospital discharge psychomotor therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Post Hospital Discharge Psychomotor Therapy Intervention Program: Effect on the Development in Very Preterm Infants at 2-years Corrected Age
Actual Study Start Date : December 1, 2007
Actual Primary Completion Date : December 1, 2013
Actual Study Completion Date : July 8, 2017

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Psychomotor development assessment. [ Time Frame: Year 2 ]
    Assessed by the Bayley Scale Third Edition BSID-III.


Secondary Outcome Measures :
  1. The acceptability of the protocol by the parents for the intervention group. [ Time Frame: Month 9 ]
    Assessed by a self-questionnaire given by the neonatologist at the end of the treatment.

  2. The quality of parenting. [ Time Frame: Month 9; Year 2 ]
    Assessed by a grid (established by the team of child psychiatry neonatology).

  3. The clinical evolution of the child assessed by a standardized neurological examination. [ Time Frame: 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.



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Ages Eligible for Study:   24 Weeks to 30 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093337


Locations
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France
CH Albi
Albi, Midi-Pyrénées, France, 81013
CH Auch
Auch, Midi-Pyrénées, France, 32008
CH Cahors
Cahors, Midi-Pyrénées, France, 46005
CH Castres
Castres, Midi-Pyrénées, France, 81108
CHIVA centre hospitalier du val d'Ariège
Foix, Midi-Pyrénées, France, 09017
CH Montauban
Montauban, Midi-Pyrénées, France, 82013
CH Tarbes
Tarbes, Midi-Pyrénées, France, 65013
Hôpital des enfants
Toulouse, Midi-Pyrénées, France, 30159
Clinique Sarrus Teinturiers
Toulouse, Midi-Pyrénées, France, 31076
Clinique Ambroise Paré
Toulouse, Midi-Pyrénées, France, 31082
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Corinne Alberge, MD Hôpital des enfants, Toulouse

Publications:
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03093337     History of Changes
Other Study ID Numbers: 07 227 01
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:
Neuromotor sequelae
Cognitive disorders
Cerebral development
Psychomotoricity
Postural management
Motor coordination
Parenthood

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications