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Trial record 42 of 1541 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

Tracking Information
First Submitted Date  ICMJE March 14, 2017
First Posted Date  ICMJE March 28, 2017
Last Update Posted Date November 7, 2017
Actual Study Start Date  ICMJE December 1, 2007
Actual Primary Completion Date December 1, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
Psychomotor development assessment. [ Time Frame: Year 2 ]
Assessed by the Bayley Scale Third Edition BSID-III.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03093337 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
  • 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.
  • The quality of parenting. [ Time Frame: Month 9; Year 2 ]
    Assessed by a grid (established by the team of child psychiatry neonatology).
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psychomotor Therapy for Very Premature Infants
Official Title  ICMJE Early Post Hospital Discharge Psychomotor Therapy Intervention Program: Effect on the Development in Very Preterm Infants at 2-years Corrected Age
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Premature Infant
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Psychomotor therapy
    Early post hospital discharge psychomotor therapy.
    Intervention: Other: Early post hospital discharge psychomotor therapy
  • No Intervention: Control
    No specific support.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 21, 2017)
162
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 8, 2017
Actual Primary Completion Date December 1, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 24 Weeks to 30 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03093337
Other Study ID Numbers  ICMJE 07 227 01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Corinne Alberge, MD Hôpital des enfants, Toulouse
PRS Account University Hospital, Toulouse
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP