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Heart surgery babies may face hidden sensory struggles

NCT ID NCT05137873

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study looked at 60 babies who had heart surgery for a condition called transposition of the great vessels before 6 months of age. Researchers used a special questionnaire to check for sensory integration disorders one week after surgery, and again at one month and six months. The goal was to find out how common these sensory problems are in this group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If this study finds a high rate of sensory issues, it could lead to better screening and early support for these babies after heart surgery.
What could go wrong
This is a small, observational study with only 60 babies. It measures sensory profiles shortly after surgery, so long-term outcomes are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

60 people

The number who actually took part.

Started

Apr 2022

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

Up to 6 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

transposition of the great arteries

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Great vessels transposition surgery

Contacts and locations

Locations

  • Necker - Enfants malades hospital

    Paris, 75015, France