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

NCT05137873 | Completed

• 2 other identifiers: APHP2112662021-A02294-37
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Great Vessels Transposition Surgery

Keywords

sensory integration disorders; great vessels transposition surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

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

  1 month after surgery

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

  6 months after surgery

• Eating disorders one week after surgery

  1 week after surgery

• Eating disorders one month after surgery

  1 month after surgery

• Eating disorders 6 months after surgery

  6 months after surgery

Study Arms (1)

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)

Interventions

Dunn-2 infant Sensory Profile (PS2-N) OTHER

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

Surgery before 6 months of age

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator
• Imagine Institute: collaborator

Study Sites (1)

Necker - Enfants malades hospital

Paris, 75015, France

Location

Related Publications (4)

• 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.

  PMID: 30226082 BACKGROUND

• 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.

  PMID: 18582771 BACKGROUND

• 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.

  PMID: 8978860 BACKGROUND

• 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.

  PMID: 22379377 BACKGROUND

Study Officials

• Véronique Abadie, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: November 30, 2021
• Study Start: April 14, 2022
• Primary Completion: April 25, 2024
• Study Completion: August 5, 2024
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)