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few inclusions - DSMB recommendation
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Apneas concern about 85% of premature newborns (NB) born after less than 34 weeks of pregnancy. They are considered as an important risk factor for subsequent neuropsychological deficiency. Current pharmacological treatments are not very effective, and have side effects (agitation, irritability, sleep disorders, tachycardia). Some studies suggest that in NBs with apneas resisting to drugs, a permanent odorisation with a drop of vanillin on the incubator's pillow might reduce the frequency of apneas. This latin square design study will test a controlled olfactory stimulation method, i.e. an olfactometer which controls the odor duration, intensity, and sequence using three different odors, to reduce apneic episodes measured using 24-registration of heart and respiratory rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S0 - S1 - S2 | Experimental | S0 = no stimulation; washout; S1 = vehicle; washout; S2 = olfactory stimulation |
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| S0 - S2 - S1 | Experimental | S0 = no stimulation; washout; S2 = olfactory stimulation; washout; S1 = vehicle |
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| S1 - S0 - S2 | Experimental | S1 = vehicle; washout; S0 = no stimulation; washout; S2 = olfactory stimulation |
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| S1 - S2 -S0 | Experimental | S1 = vehicle; washout; S2 = olfactory stimulation; washout; S0 = no stimulation |
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| S2 - S0 - S1 | Experimental | S2 = olfactory stimulation; washout; S0 = no stimulation; washout; S1 = vehicle |
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| S2 - S1 - S0 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olfactory stimulations | Other | Odors are disseminated using a portable fragrance device, a prototype developed by a research unit, CNRS UMR5292. The device is outside the incubator, the only part inside is a disposable Teflon tube. The odor flux stimulates distally the NBs' nostrils. Odoriferous compounds are placed in glass tubes. This allows the olfactometer to deliver three distinct odors (to avoid habituation) in a random scheme: spearmint odor, vanilla odor, and grapefruit odor (chemicals registered by Chemical Abstracts Service), while controlling for intensity (amount of compound), duration, and odor sequence. For the vehicle period, the glass tubes remain empty. Stimulations occur every 5 minutes, for 5 seconds, they are mixed in medical gas to avoid infection. There are three 24-hour periods, and two 24-hour wash out periods, followed by a maximum of 3 days of surveillance. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of respiratory pauses between S1 and S2 | variation of the number of apnea episodes per 24hours -registered on the continuous heart / respiratory monitoring device, defined as a total cessation of breathing superior to 20 seconds (single apnea) or ≤ 20 seconds with decreased heart rate <80 beats / min) - between olfactory stimulation (S2) and placebo stimulation (S1). | per 24hours |
| Measure | Description | Time Frame |
|---|---|---|
| difference of the number of apnea episodes between S1 and S2 | difference of the number of apnea episodes between S1 and S2 adjusted on the order of stimulations, gestational age, concomitant treatments likely to interfere with breathing and their dosage | per 24hours |
| difference of the number of apnea episodes between S0 and S2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HELENE GAUTHIER MOULINIER | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Femme Mère Enfant | Bron | France | ||||
| CHU de Saint-Etienne |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34518252 | Derived | Duchamp-Viret P, Nguyen HK, Maucort-Boulch D, Remontet L, Guyon A, Franco P, Cividjian A, Thevenet M, Iwaz J, Galletti S, Kassai B, Cornaton E, Plaisant F, Claris O, Gauthier-Moulinier H. Protocol of controlled odorant stimulation for reducing apnoeic episodes in premature newborns: a randomised open-label Latin-square study with independent evaluation of the main endpoint (PREMODEUR). BMJ Open. 2021 Sep 13;11(9):e047141. doi: 10.1136/bmjopen-2020-047141. |
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S2 = olfactory stimulation; washout; S1 = vehicle; washout S0 = no stimulation
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difference in the number of apnea episodes between olfactory stimulation (S2) and no stimulation (S0) |
| per 24hours |
| adverse events | up to day 8 |
| Saint-Etienne |
| France |