Premature Newborns With Gestational Age 28 to 33 Weeks
Conditions
Keywords
premature newborns, apneas prevention, olfactory stimulation, latin square design
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.
Interventions
OTHEROlfactory stimulations
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.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Days to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of respiratory pauses between S1 and S2 | per 24hours | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| difference of the number of apnea episodes between S1 and S2 | per 24hours | 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 |
| difference of the number of apnea episodes between S0 and S2 | per 24hours | difference in the number of apnea episodes between olfactory stimulation (S2) and no stimulation (S0) |
| adverse events | up to day 8 | — |
Countries
France
Outcome results
None listed