Odors to Insufflate Life

Not Applicable

Terminated

• Conditions: Premature Newborns With Gestational Age 28 to 33 Weeks
• Interventions: Other: Olfactory stimulations

• Registration Number: NCT02851979
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-28
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-08-02
• Study Start: 2018-11-09
• Primary Completion: 2023-03-28
• Study Completion: 2023-03-28
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
S2 - S1 - S0	Olfactory stimulations	S2 = olfactory stimulation; washout; S1 = vehicle; washout S0 = no stimulation
S2 - S0 - S1	Olfactory stimulations	S2 = olfactory stimulation; washout; S0 = no stimulation; washout; S1 = vehicle
S0 - S1 - S2	Olfactory stimulations	S0 = no stimulation; washout; S1 = vehicle; washout; S2 = olfactory stimulation
S0 - S2 - S1	Olfactory stimulations	S0 = no stimulation; washout; S2 = olfactory stimulation; washout; S1 = vehicle
S1 - S2 -S0	Olfactory stimulations	S1 = vehicle; washout; S2 = olfactory stimulation; washout; S0 = no stimulation
S1 - S0 - S2	Olfactory stimulations	S1 = vehicle; washout; S0 = no stimulation; washout; S2 = olfactory stimulation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
adverse events	up to day 8
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)

Trial Locations

Locations (2)

CHU de Saint-Etienne; 🇫🇷 Saint-Étienne, France

Hopital Femme Mère Enfant; 🇫🇷 Bron, France