Odors to Insufflate Life (PREMODEUR)

February 14, 2024 updated by: Hospices Civils de Lyon

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Bron, France
        • Hopital Femme Mere Enfant
      • Saint-Étienne, France
        • CHU de Saint-Étienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 days and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: S0 - S1 - S2
S0 = no stimulation; washout; S1 = vehicle; washout; S2 = olfactory stimulation
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.
Experimental: S0 - S2 - S1
S0 = no stimulation; washout; S2 = olfactory stimulation; washout; S1 = vehicle
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.
Experimental: S1 - S0 - S2
S1 = vehicle; washout; S0 = no stimulation; washout; S2 = olfactory stimulation
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.
Experimental: S1 - S2 -S0
S1 = vehicle; washout; S2 = olfactory stimulation; washout; S0 = no stimulation
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.
Experimental: S2 - S0 - S1
S2 = olfactory stimulation; washout; S0 = no stimulation; washout; S1 = vehicle
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.
Experimental: S2 - S1 - S0
S2 = olfactory stimulation; washout; S1 = vehicle; washout S0 = no stimulation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of respiratory pauses between S1 and S2
Time Frame: 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).
per 24hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
difference of the number of apnea episodes between S1 and S2
Time Frame: 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
per 24hours
difference of the number of apnea episodes between S0 and S2
Time Frame: per 24hours
difference in the number of apnea episodes between olfactory stimulation (S2) and no stimulation (S0)
per 24hours
adverse events
Time Frame: up to day 8
up to day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: HELENE GAUTHIER MOULINIER, Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2016

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL16_0078

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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