Odors to Insufflate Life

Premature Newborns With Gestational Age 28 to 33 Weeks Clinical Trial

— PREMODEUR  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02851979
• Other study ID #: 69HCL16_0078
• Status: Terminated
• Phase: N/A
• Start date: November 9, 2018
• Est. completion date: March 28, 2023

Study information

• Verified date: February 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: March 28, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Days and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Premature Newborns With Gestational Age 28 to 33 Weeks

Intervention

Other:
• Olfactory 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.

Locations

Country	Name	City	State
France	Hopital Femme Mère Enfant	Bron
France	CHU de Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of respiratory pauses between S1 and S2	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).	per 24hours
Secondary	difference of the number of apnea episodes between S1 and S2	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	per 24hours
Secondary	difference of the number of apnea episodes between S0 and S2	difference in the number of apnea episodes between olfactory stimulation (S2) and no stimulation (S0)	per 24hours
Secondary	adverse events		up to day 8