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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-A00997-46 | Other Identifier | French ANSM |
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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychomotor therapy | Experimental | Early post hospital discharge psychomotor therapy. |
|
| Control | No Intervention | No specific support. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Psychomotor development assessment. | Assessed by the Bayley Scale Third Edition BSID-III. | Year 2 |
| Measure | Description | Time Frame |
|---|---|---|
| The acceptability of the protocol by the parents for the intervention group. | Assessed by a self-questionnaire given by the neonatologist at the end of the treatment. | Month 9 |
| The quality of parenting. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corinne Alberge, MD | Hôpital des enfants, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Albi | Albi | Midi-Pyrénées | 81013 | France | ||
| CH Auch |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15183137 | 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. | |
| 9183258 | 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. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
Assessed by a grid (established by the team of child psychiatry neonatology).
| Month 9; Year 2 |
| The clinical evolution of the child assessed by a standardized neurological examination. | Assessed during the consultations planned in the network (neonatologists of the CHU), based on a standardized neurological examination. | Months 3, 6, 9, 12, 18, 24 |
| Auch |
| Midi-Pyrénées |
| 32008 |
| France |
| CH Cahors | Cahors | Midi-Pyrénées | 46005 | France |
| CH Castres | Castres | Midi-Pyrénées | 81108 | France |
| CHIVA centre hospitalier du val d'Ariège | Foix | Midi-Pyrénées | 09017 | France |
| CH Montauban | Montauban | Midi-Pyrénées | 82013 | France |
| CH Tarbes | Tarbes | Midi-Pyrénées | 65013 | France |
| Hôpital des enfants | Toulouse | Midi-Pyrénées | 30159 | France |
| Clinique Sarrus Teinturiers | Toulouse | Midi-Pyrénées | 31076 | France |
| Clinique Ambroise Paré | Toulouse | Midi-Pyrénées | 31082 | France |
| 7684346 | 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. |
| 37191836 | Result | 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. |
| D000091642 | Urogenital Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |