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Completed

NCT Number: NCT05137873

Measurement of the Prevalence of Sensory Integration Disorders in Babies Having Heart Disease Surgery for Transposition of the Great Vessels Before 6 Months of Age

The purpose of this study is to mesure the prevalence of severe sensory integration disorders in babies after one week of their heart surgery.

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Key information

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Necker - Enfants malades hospital

Paris, 75015, France

About this study

Baby's development takes its roots in sensorimotricity. Baby coordinates different senses (visual, auditory, tactile, taste, vestibular) to understand the space around him and to implement voluntary motor strategies. These sensory links also allow him to invest hisoral zone and consolidate his oral feeding. Another good sensory integration is necessary for a child to develop harmoniously on motor and psychic levels. In 2018 the study of L. Dagenais revealed a gap in posturomotor development on babies operated on for isolated congenital heart disease. However nobody assess sensory disorders in these babies. With this study the investigators wish to clarify the sensory impact in this situation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Infant born at term (over 37 weeks)
  • With heart disease, of the transposition of the great vessels type, whether or not associated with an interventricular communication
  • Having a cranial perimeter in the norm at birth: between 32 and 37 cm.
  • Surgery scheduled before the age of 6 months
  • No opposition from parents

Exclusion criteria

  • Other disease or malformation
  • Parents who do not speak French

Treatment and study plan

Dunn-2 infant Sensory Profile (PS2-N)

Other

The Dunn-2 infant Sensory Profile evaluates the child's sensory integration process

Primary outcomes

  1. The Dunn-2 infant Sensory Profile Score one week after surgery

    Time frame: 1 week after surgery

    The Dunn-2 infant Sensory Profile evaluates a child's sensory integration process. PS2-N has 25 variables rated from 0 to 5.

    The sum of these variables is the total raw score:

    0 to 30: much less than others 31 to 40: less than the others 41 to 61 : Like the majority 62 to 71: more than the others 72 to 125 : much less than the others

Secondary outcomes

  1. The Dunn-2 infant Sensory Profile Score one month after surgery

    Time frame: 1 month after surgery

    The Dunn-2 infant Sensory Profile evaluates a child's sensory integration process

  2. The Dunn-2 infant Sensory Profile Score 6 months after surgery

    Time frame: 6 months after surgery

    The Dunn-2 infant Sensory Profile evaluates a child's sensory integration process

  3. Eating disorders one week after surgery

    Time frame: 1 week after surgery

    Eating disorders are assessed by the Montréal Children's Hospital (HME) feeding scale. HME feeding scale has 14 variables rated from 1 to 7.

    A score above 45 identifies feeding problems

  4. Eating disorders one month after surgery

    Time frame: 1 month after surgery

    Eating disorders are assessed by the HME feeding scale

  5. Eating disorders 6 months after surgery

    Time frame: 6 months after surgery

    Eating disorders are assessed by the HME feeding scale

  6. Implementation of functional rehabilitation 1 month after surgery

    Time frame: 1 month after surgery

    Collection of physiotherapy and psychomotricity needs

  7. Implementation of functional rehabilitation 6 months after surgery

    Time frame: 6 months after surgery

    Collection of physiotherapy and psychomotricity needs

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Imagine Institute
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: SENSOCOEUR

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 30, 2021
Registry last updated
Mar 23, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.