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Breathing machine may ease lung risk for kids with sickle cell

NCT ID NCT01501643

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

What the study statuses mean

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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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a non-invasive breathing machine (ventilation) could prevent acute chest syndrome, a serious lung complication, in children with sickle cell disease who were hospitalized for severe pain. The standard prevention is spirometry, which requires active deep breathing, but pain and sleep can make that hard. The trial planned to compare the two approaches in children aged 6–20, but it was stopped early after enrolling only 6 participants, so no firm conclusions can be drawn.

What this could mean

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

Active substance
non-invasive positive pressure ventilation (device)
What this could lead to
If it worked, this approach could offer a more comfortable way to prevent a serious lung complication in children with sickle cell disease during painful crises.
What could go wrong
The trial was terminated early with only 6 participants, so we have very little data. It is unclear if the device is better than standard care, and results may not apply broadly.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

6 people

The number who actually took part.

Started

Nov 2011

Finished

Apr 2015

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.

Ages

6 to 20 years

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: * Patient with SS or S-Beta sickle cell disease aged more than 6 years old and less then 20 years old * Hospitalised since less then 24 hours for severe vaso-occlusive crisis (either peripheric localisation or thoracic crisis) with morphinic requirements according to local pain management protocol * With a signed informed consent from the patient or his legal representative if the patient is under 18 years old * Benefiting of the French social security system Exclusion Criteria: * Patient that has already participated in the study * Oxygen requirements, pneumonia, acute chest syndrome or other condition necessitating non invasive ventilation on admission * No understanding of spirometry or ventilation techniques * Other condition that forbid the use of non invasive ventilation or spirometry as defined by french consensus conference (2006) on non invasive ventilation

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Conditions

The condition(s) this trial relates to.

sickle cell disease Vaso-Occlusive Crises acute chest syndrome prevention target

As listed by the trial registrant

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

Sickle cell-hemoglobin SS disease Vaso-occlusive crisis

Contacts and locations

Locations

  • Hôpital Necker - Enfants Malades Hospital

    Paris, 75015, France

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