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Odors to Insufflate Life (PREMODEUR)

Primary Purpose

Premature Newborns With Gestational Age 28 to 33 Weeks

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Olfactory stimulations
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

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

6 Days - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

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

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

S0 - S1 - S2

S0 - S2 - S1

S1 - S0 - S2

S1 - S2 -S0

S2 - S0 - S1

S2 - S1 - S0

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
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)
adverse events

Full Information

First Posted
July 28, 2016
Last Updated
December 20, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02851979
Brief Title
Odors to Insufflate Life
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2018 (Actual)
Primary Completion Date
November 21, 2024 (Anticipated)
Study Completion Date
November 21, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Newborns With Gestational Age 28 to 33 Weeks
Keywords
premature newborns, apneas prevention, olfactory stimulation, latin square design

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
S0 - S1 - S2
Arm Type
Experimental
Arm Description
S0 = no stimulation; washout; S1 = vehicle; washout; S2 = olfactory stimulation
Arm Title
S0 - S2 - S1
Arm Type
Experimental
Arm Description
S0 = no stimulation; washout; S2 = olfactory stimulation; washout; S1 = vehicle
Arm Title
S1 - S0 - S2
Arm Type
Experimental
Arm Description
S1 = vehicle; washout; S0 = no stimulation; washout; S2 = olfactory stimulation
Arm Title
S1 - S2 -S0
Arm Type
Experimental
Arm Description
S1 = vehicle; washout; S2 = olfactory stimulation; washout; S0 = no stimulation
Arm Title
S2 - S0 - S1
Arm Type
Experimental
Arm Description
S2 = olfactory stimulation; washout; S0 = no stimulation; washout; S1 = vehicle
Arm Title
S2 - S1 - S0
Arm Type
Experimental
Arm Description
S2 = olfactory stimulation; washout; S1 = vehicle; washout S0 = no stimulation
Intervention Type
Other
Intervention Name(s)
Olfactory stimulations
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of respiratory pauses between S1 and S2
Description
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).
Time Frame
per 24hours
Secondary Outcome Measure Information:
Title
difference of the number of apnea episodes between S1 and S2
Description
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
Time Frame
per 24hours
Title
difference of the number of apnea episodes between S0 and S2
Description
difference in the number of apnea episodes between olfactory stimulation (S2) and no stimulation (S0)
Time Frame
per 24hours
Title
adverse events
Time Frame
up to day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Days
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HELENE GAUTHIER MOULINIER, MD
Phone
472 117 647
Ext
+33
Email
helene.gauthier-moulinier@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sonia GALLETTI
Phone
4 72 35 72 31
Ext
+33
Email
sonia.galletti@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HELENE GAUTHIER MOULINIER
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Femme Mère Enfant
City
Bron
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène GAUTHIER MOULINIER
Phone
472 117 647
Ext
+33
Email
helene.gauthier-moulinier@chu-lyon.fr
Facility Name
CHU de Saint-Etienne
City
Saint-Étienne
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugues PATURAL, Pr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34518252
Citation
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.
Results Reference
derived

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Odors to Insufflate Life

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