Psychomotor Therapy for Very Premature Infants

Premature Infant Clinical Trial

— VPI  

Official title:

Early Post Hospital Discharge Psychomotor Therapy Intervention Program: Effect on the Development in Very Preterm Infants at 2-years Corrected Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03093337
• Other study ID #: 07 227 01
• Status: Completed
• Phase: N/A
• Start date: December 1, 2007
• Est. completion date: July 8, 2017

Study information

• Verified date: May 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: July 8, 2017
• Est. primary completion date: December 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks to 30 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Premature Infant

Intervention

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.

Locations

Country	Name	City	State
France	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	Clinique Ambroise Paré	Toulouse	Midi-Pyrénées
France	Clinique Sarrus Teinturiers	Toulouse	Midi-Pyrénées
France	Hôpital des enfants	Toulouse	Midi-Pyrénées

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (7)

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 May 16. doi: 10.1111/apa.16848. Online ahe — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychomotor development assessment.	Assessed by the Bayley Scale Third Edition BSID-III.	Year 2
Secondary	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
Secondary	The quality of parenting.	Assessed by a grid (established by the team of child psychiatry neonatology).	Month 9; Year 2
Secondary	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