An interventional study of NAVA in Infantile Spinal Muscular Atrophy, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2022-03-29.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
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Among 11 studies in Spinal Muscular Atrophies of Childhood with a site in France — 3 open to participants now, 5 under way, 2 of them phase 3. Spinal Muscular Atrophies of Childhood · France.
Among the 11 studies in Spinal Muscular Atrophies of Childhood with a site in France, this one is the 10th largest by enrollment, is the only one that started in 2018, is one of 6 with no phase, and was the 4th registered.
61 studies on the registry are indexed under Spinal Muscular Atrophies of Childhood; 18 are open to participants now.
Browse Spinal Muscular Atrophies of Childhood studies →3 of the 11 studies in Spinal Muscular Atrophies of Childhood with a site in France are open now. Recruiting first, the newest first:
Scholar Rock, Inc. · Sites in France, United States, Belgium and 4 more countries
Ages up to 2
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages up to 12 mo
Centre Hospitalier Universitaire de Saint Etienne · Sites in France
Ages 6+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 12 Spinal Muscular Atrophies of Childhood studies recruiting now, 5 (42%) set no upper age limit and 7 (58%) stop at 75 or younger; 11 take children under 18; 2 take healthy volunteers.
This study: 1 Year to 18 Years · all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 1 started in 2018.
This study's enrollment of 1 is below the median of 15 across 41 interventional studies indexed under Spinal Muscular Atrophies of Childhood.
Median enrollment 80 across the 11 interventional studies. Of the 5 that completed or were terminated, 0 (0%) have results posted.
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5 of 11 have an industry lead sponsor. The 6 most frequent:
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,596 studies on the registry; 1,037 are open to participants now.
Assistance Publique - Hôpitaux de Paris has 3 studies filed under Spinal Muscular Atrophies of Childhood — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Spinal Muscular Atrophies of Childhood with a site in France, from their registry updates:
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The new NAVA® ventilatory mode with the SERVO-i ventilator (Maquet®) uses the electrical activity of the diaphragm (EADi) as a marker for triggering the respiratory cycle. The EADi is captured by the electrodes of a specific catheter (the Edi® catheter) placed in the esophagus as a regular gastric feeding tube, and relayed to the SERVO-i who displays it and delivers respiratory assistance according to measured Edi signal which allows synchronous assistance, proportional to the respiratory efforts of the patient.
To date, no measure of the effectiveness of NAVA NAV has been performed in children with neuromuscular pathology whereas this technique could reduce the use of invasive ventilation, very iatrogenic in these fragile subjects.
This is a prospective, interventional, sequential, open-label research involving ASI II children with acute respiratory decompensation requiring ventilatory support by NIV. Airway pressure, transcutaneous CO2 monitoring and hemodynamic parameters will be recorded continuously during the study, after inclusion of the patient.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single arm trial, every patient enroll in this study will follow the same protocol with classic and NAVA mode non-invasive ventilation.
Device: NAVA
The study has 3 phases: 1. Phase 1: The patient is connected to the SERVOi® ventilator in classic VNI mode, which is parameterized according to the patient's needs and then maintained for 30min for measurements. 2. Phase 2: Switch to NAVA mode (1h). * Definition of NAVA parameters: The positive expiratory pressure will not be modified. The NAVA level (the proportionality factor that converts the EADi (microV) to the pressure level in cmH2O was first adjusted according to the actual assisted pressure in the patient in the normal VNI mode. * NAVA period: The ventilatory pressure, as well as the EADI is recorded continuously for 30min after a NAVA adaptation period of about 30min. 3. Phase 3: The patient returns to classic VNI mode with Phase 1 ventilatory settings for a 30 minute recording.
Asynchrony percentage
Asynchrony percentage of non-synchronous breath cycles over all cycles of the measurement period, unaided breaths, self-initiated cycles.
Time frame: At baseline
Feasibility
Frequency of obtaining an EADi signal
Time frame: At baseline
Feasibility
Percentage of effective time spent in activated NAVA mode
Time frame: At baseline
Efficacy and tolerance
Efficacy and tolerance: during the whole of the study period (2h30), the monitoring of transcutaneous CO2 pressure (PtcCO2) will be collected.
Time frame: At 30 minutes and 60 minutes
Efficacy and tolerance
Efficacy and tolerance: during the whole of the study period (2h30), evolution of respiratory rate will be collected.
Time frame: At 30 minutes and 60 minutes
Efficacy and tolerance
O2 saturation will be collected.
Time frame: At 30 minutes and 60 minutes
Efficacy and tolerance
FiO2 after 30 and 60 minutes under each ventilation mode will be collected.
Time frame: At 30 minutes and 60 minutes
Rate of recourse to intubation
Rate of recourse to intubation, patient preference.
Time frame: At baseline
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Dec 2019, 22 months.
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Spinal Muscular Atrophies of Childhood →
Assistance Publique - Hôpitaux de Paris →