Clinical trial 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Great Vessels Transposition Surgery
Keywords: sensory integration disorders
great vessels transposition surgery
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: URC-CIC Paris Descartes Necker Cochin
name: Imagine Institute
First posted: 2021-11-30
Enrollment: 60
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Babies with heart disease surgery, great vessels transposition surgery type before 6 months of age

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Dunn-2 infant Sensory Profile Score one week after surgery
timeFrame: 1 week after surgery
Secondary outcomes:
measure: The Dunn-2 infant Sensory Profile Score one month after surgery
timeFrame: 1 month after surgery
measure: The Dunn-2 infant Sensory Profile Score 6 months after surgery
timeFrame: 6 months after surgery
measure: Eating disorders one week after surgery
timeFrame: 1 week after surgery
measure: Eating disorders one month after surgery
timeFrame: 1 month after surgery
measure: Eating disorders 6 months after surgery
timeFrame: 6 months after surgery
measure: Implementation of functional rehabilitation 1 month after surgery
timeFrame: 1 month after surgery
measure: Implementation of functional rehabilitation 6 months after surgery
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker - Enfants malades hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Véronique Abadie, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Dagenais L, Materassi M, Desnous B, Vinay MC, Doussau A, Sabeh P, Prud'homme J, BSc KG, Lenoir M, Charron MA, Nuyt AM, Poirier N, Beaulieu-Genest L, Carmant L, Birca A. Superior Performance in Prone in Infants With Congenital Heart Disease Predicts an Earlier Onset of Walking. J Child Neurol. 2018 Dec;33(14):894-900. doi: 10.1177/0883073818798194. Epub 2018 Sep 18.
citation: Abadie V. [Apparently isolated feeding behavior troubles in infant]. Arch Pediatr. 2008 Jun;15(5):837-9. doi: 10.1016/S0929-693X(08)71932-8. No abstract available. French.
citation: Dunn W, Westman K. The sensory profile: the performance of a national sample of children without disabilities. Am J Occup Ther. 1997 Jan;51(1):25-34. doi: 10.5014/ajot.51.1.25.
citation: Ramsay M, Martel C, Porporino M, Zygmuntowicz C. The Montreal Children's Hospital Feeding Scale: A brief bilingual screening tool for identifying feeding problems. Paediatr Child Health. 2011 Mar;16(3):147-e17. doi: 10.1093/pch/16.3.147.