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 (SENSOCOEUR)

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

Study Overview

• Status: Completed
• Conditions: Great Vessels Transposition Surgery
• Intervention / Treatment: Other: Dunn-2 infant Sensory Profile (PS2-N)

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Necker - Enfants Malades Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Babies with heart disease surgery, great vessels transposition surgery type before 6 months of age

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgery before 6 months of age; Babies with heart disease surgery, great vessels transposition surgery type before 6 months of age	Other: Dunn-2 infant Sensory Profile (PS2-N); The Dunn-2 infant Sensory Profile evaluates the child's sensory integration process

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Dunn-2 infant Sensory Profile Score one 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	1 week after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Dunn-2 infant Sensory Profile Score one month after surgery	The Dunn-2 infant Sensory Profile evaluates a child's sensory integration process	1 month after surgery
The Dunn-2 infant Sensory Profile Score 6 months after surgery	The Dunn-2 infant Sensory Profile evaluates a child's sensory integration process	6 months after surgery
Eating disorders one 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	1 week after surgery
Eating disorders one month after surgery	Eating disorders are assessed by the HME feeding scale	1 month after surgery
Eating disorders 6 months after surgery	Eating disorders are assessed by the HME feeding scale	6 months after surgery
Implementation of functional rehabilitation 1 month after surgery	Collection of physiotherapy and psychomotricity needs	1 month after surgery
Implementation of functional rehabilitation 6 months after surgery	Collection of physiotherapy and psychomotricity needs	6 months after surgery

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin; Imagine Institute
• Investigators: Study Director: Véronique Abadie, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2022
• Primary Completion (Actual): April 25, 2024
• Study Completion (Actual): August 5, 2024

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (Actual): November 30, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: sensory integration disorders; great vessels transposition surgery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Transposition of Great Vessels; Situs Inversus
• Other Study ID Numbers: APHP211266; 2021-A02294-37 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No