Great Vessels Transposition SurgerySENSOCOEURNCT05137873
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
An observational study of Great Vessels Transposition Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Great Vessels Transposition Surgery
- What is being tested?
- Dunn-2 infant Sensory Profile (PS2-N)
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2022to 5 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Babies with heart disease surgery, great vessels transposition surgery type before 6 months of age
Who may be able to join
- 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
Who cannot join
- Other disease or malformation
- Parents who do not speak French
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to mesure the prevalence of severe sensory integration disorders in babies after one week of their heart surgery.
Read the 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.
- Conditions
- Great Vessels Transposition Surgery
- Being tested
- Dunn-2 infant Sensory Profile (PS2-N)
- Keywords
- sensory integration disorders, great vessels transposition surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dunn-2 infant Sensory Profile (PS2-N)Other
The Dunn-2 infant Sensory Profile evaluates the child's sensory integration process
| Study group | Role | What they receive |
|---|---|---|
| Surgery before 6 months of age | Babies with heart disease surgery, great vessels transposition surgery type before 6 months of age Receives: Other: Dunn-2 infant Sensory Profile (PS2-N) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week after surgery
Secondary outcomes (7)
The Dunn-2 infant Sensory Profile Score one month after surgery
The Dunn-2 infant Sensory Profile evaluates a child's sensory integration process
Measured: 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
Measured: 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
Measured: 1 week after surgery
Eating disorders one month after surgery
Eating disorders are assessed by the HME feeding scale
Measured: 1 month after surgery
Eating disorders 6 months after surgery
Eating disorders are assessed by the HME feeding scale
Measured: 6 months after surgery
Implementation of functional rehabilitation 1 month after surgery
Collection of physiotherapy and psychomotricity needs
Measured: 1 month after surgery
Implementation of functional rehabilitation 6 months after surgery
Collection of physiotherapy and psychomotricity needs
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start14 Apr 2022
- Primary completion25 Apr 2024
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Great Vessels Transposition SurgeryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Imagine Institute, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Véronique Abadie, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137873
- Sponsor's protocol ID
- APHP211266
- Other IDs
- 2021-A02294-37
- Acronym
- SENSOCOEUR
- Status last verified
- Mar 2026
- First submitted
- 16 Nov 2021
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30226082Abadie 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.
PubMed 18582771Dunn 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.
PubMed 8978860Ramsay 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.
PubMed 22379377
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05137873
- Acronym / sponsor ID
- SENSOCOEUR / APHP211266
- Conditions
- Great Vessels Transposition Surgery
- Keywords
- sensory integration disorders, great vessels transposition surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Imagine Institute, URC-CIC Paris Descartes Necker Cochin
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery before 6 months of age | – | Other: Dunn-2 infant Sensory Profile (PS2-N)Babies with heart disease surgery, great vessels transposition surgery type before 6 months of age |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Babies with heart disease surgery, great vessels transposition surgery type before 6 months of age
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Other disease or malformation
- Parents who do not speak French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dunn-2 infant Sensory Profile (PS2-N)The Dunn-2 infant Sensory Profile evaluates the child's sensory integration process | Other | Surgery before 6 months of age |
Primary outcome
The Dunn-2 infant Sensory Profile Score one week after surgery
Time frame: 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
7 secondary outcomes
The Dunn-2 infant Sensory Profile Score one month after surgery
Time frame: 1 month after surgery
The Dunn-2 infant Sensory Profile Score 6 months after surgery
Time frame: 6 months after surgery
Eating disorders one week after surgery
Time frame: 1 week after surgery
Eating disorders one month after surgery
Time frame: 1 month after surgery
Eating disorders 6 months after surgery
Time frame: 6 months after surgery
Implementation of functional rehabilitation 1 month after surgery
Time frame: 1 month after surgery
Implementation of functional rehabilitation 6 months after surgery
Time frame: 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Background: PubMed 30226082Dagenais 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.
- Background: PubMed 18582771Abadie 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.
- Background: PubMed 8978860Dunn 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.
- Background: PubMed 22379377Ramsay 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Véronique Abadie, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Great Vessels Transposition Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Dunn-2 infant Sensory Profile Score one week after surgery (time frame: 1 week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05137873, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.