Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
162 participants
INTERVENTIONAL
2007-12-01
2017-07-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Psychomotor therapy
Early post hospital discharge psychomotor therapy.
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.
Control
No specific support.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
24 Weeks
30 Weeks
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Corinne Alberge, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital des enfants, Toulouse
Locations
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CH Albi
Albi, Midi-Pyrénées, France
CH Auch
Auch, Midi-Pyrénées, France
CH Cahors
Cahors, Midi-Pyrénées, France
CH Castres
Castres, Midi-Pyrénées, France
CHIVA centre hospitalier du val d'Ariège
Foix, Midi-Pyrénées, France
CH Montauban
Montauban, Midi-Pyrénées, France
CH Tarbes
Tarbes, Midi-Pyrénées, France
Hôpital des enfants
Toulouse, Midi-Pyrénées, France
Clinique Sarrus Teinturiers
Toulouse, Midi-Pyrénées, France
Clinique Ambroise Paré
Toulouse, Midi-Pyrénées, France
Countries
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References
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Shevell MI, Bodensteiner JB. Cerebral palsy: defining the problem. Semin Pediatr Neurol. 2004 Mar;11(1):2-4. doi: 10.1016/j.spen.2004.01.001.
Hagberg B, Hagberg G, Beckung E, Uvebrant P. Changing panorama of cerebral palsy in Sweden. VIII. Prevalence and origin in the birth year period 1991-94. Acta Paediatr. 2001 Mar;90(3):271-7.
Nelson KB. Can we prevent cerebral palsy? N Engl J Med. 2003 Oct 30;349(18):1765-9. doi: 10.1056/NEJMsb035364. No abstract available.
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.
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.
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.
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.
Other Identifiers
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07 227 01
Identifier Type: -
Identifier Source: org_study_id
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