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Psychomotor Therapy for Very Premature Infants (VPI)

T

Toulouse University Hospital

Status

Completed

Conditions

Premature Infant

Treatments

Other: Early post hospital discharge psychomotor therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03093337
07 227 01

Details and patient eligibility

About

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).

Full 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.

Enrollment

162 patients

Sex

All

Ages

24 to 30 weeks old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

162 participants in 2 patient groups

Psychomotor therapy
Experimental group
Description:
Early post hospital discharge psychomotor therapy.
Treatment:
Other: Early post hospital discharge psychomotor therapy
Control
No Intervention group
Description:
No specific support.

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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