Odors to Insufflate Life

NCT02851979 | Terminated DMC

• 1 other identifier: 69HCL16_0078
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Premature Newborns With Gestational Age 28 to 33 Weeks

Keywords

premature newborns; apneas prevention; olfactory stimulation; latin square design

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• difference of the number of apnea episodes between S1 and S2

  per 24hours

• difference of the number of apnea episodes between S0 and S2

  per 24hours

• adverse events

  up to day 8

Study Arms (6)

S0 - S1 - S2

EXPERIMENTAL

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

Other: Olfactory stimulations

S0 - S2 - S1

EXPERIMENTAL

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

Other: Olfactory stimulations

S1 - S0 - S2

EXPERIMENTAL

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

Other: Olfactory stimulations

S1 - S2 -S0

EXPERIMENTAL

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

Other: Olfactory stimulations

S2 - S0 - S1

EXPERIMENTAL

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

Other: Olfactory stimulations

S2 - S1 - S0

EXPERIMENTAL

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

Other: Olfactory stimulations

Interventions

Olfactory stimulations OTHER

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.

S0 - S1 - S2; S0 - S2 - S1; S1 - S0 - S2; S1 - S2 -S0; S2 - S0 - S1; S2 - S1 - S0

Eligibility Criteria

• Age: 6 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Hopital Femme Mère Enfant

Bron, France

Location

CHU de Saint-Etienne

Saint-Etienne, France

Location

Related Publications (1)

• Duchamp-Viret P, Nguyen HK, Maucort-Boulch D, Remontet L, Guyon A, Franco P, Cividjian A, Thevenet M, Iwaz J, Galletti S, Kassai B, Cornaton E, Plaisant F, Claris O, Gauthier-Moulinier H. Protocol of controlled odorant stimulation for reducing apnoeic episodes in premature newborns: a randomised open-label Latin-square study with independent evaluation of the main endpoint (PREMODEUR). BMJ Open. 2021 Sep 13;11(9):e047141. doi: 10.1136/bmjopen-2020-047141.

  PMID: 34518252 DERIVED

Study Officials

• HELENE GAUTHIER MOULINIER

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 2, 2016
• Study Start: November 9, 2018
• Primary Completion: March 28, 2023
• Study Completion: March 28, 2023
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)