Odors to Insufflate Life (PREMODEUR)

Civil Hospices of Lyon

Status: Terminated

Conditions: Premature Newborns With Gestational Age 28 to 33 Weeks

Treatments: Other: Olfactory stimulations

Study type: Interventional

Funder types: Other

Identifiers

NCT02851979

69HCL16_0078

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 6+ days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 6 patient groups

S0 - S1 - S2

Experimental group

Description:

S0 = no stimulation; washout; S1 = vehicle; washout; S2 = olfactory stimulation

Treatment:

Other: Olfactory stimulations

S0 - S2 - S1

Experimental group

Description:

S0 = no stimulation; washout; S2 = olfactory stimulation; washout; S1 = vehicle

Treatment:

Other: Olfactory stimulations

S1 - S0 - S2

Experimental group

Description:

S1 = vehicle; washout; S0 = no stimulation; washout; S2 = olfactory stimulation

Treatment:

Other: Olfactory stimulations

S1 - S2 -S0

Experimental group

Description:

S1 = vehicle; washout; S2 = olfactory stimulation; washout; S0 = no stimulation

Treatment:

Other: Olfactory stimulations

S2 - S0 - S1

Experimental group

Description:

S2 = olfactory stimulation; washout; S0 = no stimulation; washout; S1 = vehicle

Treatment:

Other: Olfactory stimulations

S2 - S1 - S0

Experimental group

Description:

S2 = olfactory stimulation; washout; S1 = vehicle; washout S0 = no stimulation

Treatment:

Other: Olfactory stimulations