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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05137873
Acronym
SENSOCOEUR
Enrollment
60
Registered
2021-11-30
Start date
2022-04-14
Completion date
2024-08-05
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Great Vessels Transposition Surgery

Keywords

sensory integration disorders, great vessels transposition surgery

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.

Interventions

OTHERDunn-2 infant Sensory Profile (PS2-N)

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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER
Imagine Institute
CollaboratorOTHER
URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The Dunn-2 infant Sensory Profile Score one week after surgery1 week after surgeryThe 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

MeasureTime frameDescription
The Dunn-2 infant Sensory Profile Score one month after surgery1 month after surgeryThe Dunn-2 infant Sensory Profile evaluates a child's sensory integration process
The Dunn-2 infant Sensory Profile Score 6 months after surgery6 months after surgeryThe Dunn-2 infant Sensory Profile evaluates a child's sensory integration process
Eating disorders one week after surgery1 week after surgeryEating 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
Eating disorders one month after surgery1 month after surgeryEating disorders are assessed by the HME feeding scale
Eating disorders 6 months after surgery6 months after surgeryEating disorders are assessed by the HME feeding scale
Implementation of functional rehabilitation 1 month after surgery1 month after surgeryCollection of physiotherapy and psychomotricity needs
Implementation of functional rehabilitation 6 months after surgery6 months after surgeryCollection of physiotherapy and psychomotricity needs

Countries

France

Contacts

STUDY_DIRECTORVéronique Abadie, MD, PhD

Assistance Publique - Hôpitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026