Clinical trial NCT02851979: Odors to Insufflate Life
Official title: PREMODEUR. "Odors to Insufflate Life". Implementation of a Controlled Olfactory Sensorial Method to Decrease Apneas in Premature Newborns. Proof of Concept Study. Latin-square Open Study With Blind Evaluation of Primary Outcome.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Premature Newborns With Gestational Age 28 to 33 Weeks
Keywords: premature newborns
apneas prevention
olfactory stimulation
latin square design
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Newborns from a single or multiple pregnancy
* Newborns hospitalized in the Lyon East or Saint-Etienne neonatology services, of both sexes, born before 33 weeks of amenorrhea and after at least 6 days of life, without respiratory disease beside premature birth.
* Newborns must present at least 3 bradycardia during 3 days, or presenting apneas at observation.
* Newborns will be randomized if they present at least 3 apnea episodes per 24 hour monitored by RECAN for 3 consecutive days prior to randomization.
* Written informed consents obtained from the newborns parents or legal representatives

Exclusion Criteria:

* Severe congenital malformation
* History of allergic reaction to smell stimulation (cough, sneeze, watery eyes, breathing pauses)
* No social insurance

Primary outcomes:
measure: Number of respiratory pauses between S1 and S2
timeFrame: per 24hours
Secondary outcomes:
measure: difference of the number of apnea episodes between S1 and S2
timeFrame: per 24hours
measure: difference of the number of apnea episodes between S0 and S2
timeFrame: per 24hours
measure: adverse events
timeFrame: up to day 8
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Femme Mère Enfant
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: Hospices Civils de Lyon
name: HELENE GAUTHIER MOULINIER
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.