Clinical trial NCT03093337: Psychomotor Therapy for Very Premature Infants
Official title: Early Post Hospital Discharge Psychomotor Therapy Intervention Program: Effect on the Development in Very Preterm Infants at 2-years Corrected Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Infant
Keywords: Neuromotor sequelae
Cognitive disorders
Cerebral development
Psychomotoricity
Postural management
Motor coordination
Parenthood
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2017-03-28
Enrollment: 162
Sex: ALL
Minimum age (years): 24
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Psychomotor development assessment.
timeFrame: Year 2
Secondary outcomes:
measure: The acceptability of the protocol by the parents for the intervention group.
timeFrame: Month 9
measure: The quality of parenting.
timeFrame: Month 9; Year 2
measure: The clinical evolution of the child assessed by a standardized neurological examination.
timeFrame: Months 3, 6, 9, 12, 18, 24
Other outcomes:
Locations:
city: Albi
country: France
facility: CH Albi
state: Midi-Pyrénées
city: Auch
country: France
facility: CH Auch
state: Midi-Pyrénées
city: Cahors
country: France
facility: CH Cahors
state: Midi-Pyrénées
city: Castres
country: France
facility: CH Castres
state: Midi-Pyrénées
city: Foix
country: France
facility: CHIVA centre hospitalier du val d'Ariège
state: Midi-Pyrénées
city: Montauban
country: France
facility: CH Montauban
state: Midi-Pyrénées
city: Tarbes
country: France
facility: CH Tarbes
state: Midi-Pyrénées
city: Toulouse
country: France
facility: Hôpital des enfants
state: Midi-Pyrénées
city: Toulouse
country: France
facility: Clinique Sarrus Teinturiers
state: Midi-Pyrénées
city: Toulouse
country: France
facility: Clinique Ambroise Paré
state: Midi-Pyrénées
Study officials:
affiliation: Hôpital des enfants, Toulouse
name: Corinne Alberge, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.