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
|Condition or disease||Intervention/treatment||Phase|
|Premature Infant||Other: Early post hospital discharge psychomotor therapy||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||162 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- Psychomotor development assessment. [ Time Frame: Year 2 ]Assessed by the Bayley Scale Third Edition BSID-III.
- 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.
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
|Albi, Midi-Pyrénées, France, 81013|
|Auch, Midi-Pyrénées, France, 32008|
|Cahors, Midi-Pyrénées, France, 46005|
|Castres, Midi-Pyrénées, France, 81108|
|CHIVA centre hospitalier du val d'Ariège|
|Foix, Midi-Pyrénées, France, 09017|
|Montauban, Midi-Pyrénées, France, 82013|
|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|
|Principal Investigator:||Corinne Alberge, MD||Hôpital des enfants, Toulouse|