Odors to Insufflate Life (PREMODEUR)
Premature Newborns With Gestational Age 28 to 33 Weeks
About this trial
This is an interventional treatment trial for Premature Newborns With Gestational Age 28 to 33 Weeks focused on measuring premature newborns, apneas prevention, olfactory stimulation, latin square design
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
Sites / Locations
- Hopital Femme Mère EnfantRecruiting
- CHU de Saint-Etienne
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
S0 - S1 - S2
S0 - S2 - S1
S1 - S0 - S2
S1 - S2 -S0
S2 - S0 - S1
S2 - S1 - S0
S0 = no stimulation; washout; S1 = vehicle; washout; S2 = olfactory stimulation
S0 = no stimulation; washout; S2 = olfactory stimulation; washout; S1 = vehicle
S1 = vehicle; washout; S0 = no stimulation; washout; S2 = olfactory stimulation
S1 = vehicle; washout; S2 = olfactory stimulation; washout; S0 = no stimulation
S2 = olfactory stimulation; washout; S0 = no stimulation; washout; S1 = vehicle
S2 = olfactory stimulation; washout; S1 = vehicle; washout S0 = no stimulation