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Completed

NCT Number: NCT03093337

Psychomotor Therapy for Very Premature Infants

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).

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Key information

Conditions

Premature Infant Cognition Disorders Cognitive Dysfunction Female Urogenital Diseases and Pregnancy Complications Mental Disorders Neurocognitive Disorders Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

24 week–30 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Albi, Albi, Midi-Pyrénées, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Psychomotor development assessment.

    Time frame: Year 2

    Assessed by the Bayley Scale Third Edition BSID-III.

Secondary outcomes

  1. The acceptability of the protocol by the parents for the intervention group.

    Time frame: Month 9

    Assessed by a self-questionnaire given by the neonatologist at the end of the treatment.

  2. The quality of parenting.

    Time frame: Month 9; Year 2

    Assessed by a grid (established by the team of child psychiatry neonatology).

  3. The clinical evolution of the child assessed by a standardized neurological examination.

    Time frame: Months 3, 6, 9, 12, 18, 24

    Assessed during the consultations planned in the network (neonatologists of the CHU), based on a standardized neurological examination.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: VPI

Important dates

Study start
2007
Primary completion
2013
Study completion
2017
First posted
Mar 28, 2017
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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