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
- Conditions
- Great Vessels Transposition Surgery
- Interventions
- Other: Dunn-2 infant Sensory Profile (PS2-N)
- Registration Number
- NCT05137873
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
The purpose of this study is to mesure the prevalence of severe sensory integration disorders in babies after one week of their heart surgery.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
- Other disease or malformation
- Parents who do not speak French
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Surgery before 6 months of age Dunn-2 infant Sensory Profile (PS2-N) Babies with heart disease surgery, great vessels transposition surgery type before 6 months of age
- Primary Outcome Measures
Name Time Method The Dunn-2 infant Sensory Profile Score one week after surgery 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 Outcome Measures
Name Time Method The Dunn-2 infant Sensory Profile Score one month after surgery 1 month after surgery The Dunn-2 infant Sensory Profile evaluates a child's sensory integration process
Eating disorders 6 months after surgery 6 months after surgery Eating disorders are assessed by the HME feeding scale
Eating disorders one month after surgery 1 month after surgery Eating disorders are assessed by the HME feeding scale
The Dunn-2 infant Sensory Profile Score 6 months after surgery 6 months after surgery The Dunn-2 infant Sensory Profile evaluates a child's sensory integration process
Implementation of functional rehabilitation 1 month after surgery 1 month after surgery Collection of physiotherapy and psychomotricity needs
Implementation of functional rehabilitation 6 months after surgery 6 months after surgery Collection of physiotherapy and psychomotricity needs
Eating disorders one week after surgery 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
Trial Locations
- Locations (1)
Necker - Enfants malades hospital
🇫🇷Paris, France