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The purpose of this study is to evaluate the effect of vanilla odor on hypoxic intermittent events in premature infants born between 32.0 and 33.6 weeks of gestational age.
A weekly screening will be done on all new hospitalized infants at the neonatal care unit of the CHUS born between 32.0 and 33.6 weeks of gestational age. At the beginning of their 2nd week in the neonatal care unit, infant's medical record will be consulted for inclusion and exclusion criteria. At this moment, no information will be noted. Then, team research will discuss with neonatologist to have their opinion concerning the inclusion of a patient in the study. If they agree, the doctor or the nurse having a therapeutic link with the infant will ask parents' infant if they agree to meet the research team to discuss about the research project. Once the agreement will be obtained, parents will be approached by a member of the research team. Project will be explained, questions will be answered and consent form will be obtained. When an infant will be enrolled in the study, a code will be attributed to him and a randomization will established the order of the intervention.
Option A) night 1: a 12h cardiorespiratory recording with vanilla, night 2: no recording and night 3: a 12h cardiorespiratory recording without vanilla OR Option B): night 1: a 12h cardiorespiratory recording without vanilla, night 2: no recording and night 3: a 12h cardiorespiratory recording recording with vanilla.
All data will be entered in a secured database and a double checked will be done by team members to assess the accuracy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vanilla, Then no vanilla night | Experimental | Participants were exposed to vanilla odor (2 mL of 2% vanillin on the bib, close to the face) on the first night (12-hour recording), and not exposed to vanilla on the third night (control night,12-hour recording) No intervention, no recordings were made on the second night |
|
| No vanilla, Then vanilla night | Experimental | Participants were exposed to the "control" condition on the first night, which consisted of no vanilla odor (12-hour recording), and then exposed to vanilla odor on the third night (2 mL of 2% vanillin on the bib, close to the face;12-hour recording) No intervention, no recordings were made on the second night |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vanilla scent | Other | A 12-hour continuous recording for monitoring hemoglobin oxygen saturation, electrocardiogram and respiratory movements will be performed while the infant is exposed to vanilla scent (from vanilla solution on the infant's pyjamas). |
| Measure | Description | Time Frame |
|---|---|---|
| Desaturation Index | Number per hour of oxygen saturation < 90% for at least 5 seconds | 12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odor |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time of Oxygen Saturation Under 90% | Percentage time in overall duration of oxygen saturation under 90% | 12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odor |
| Percentage of Time of Periodic Breathing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Paul Praud, MD, PhD | Université de Sherbrooke | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nicu - Chus | Sherbrooke | Quebec | J1H5N4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24211071 | Background | Brockmann PE, Poets A, Poets CF. Reference values for respiratory events in overnight polygraphy from infants aged 1 and 3months. Sleep Med. 2013 Dec;14(12):1323-7. doi: 10.1016/j.sleep.2013.07.016. Epub 2013 Oct 14. | |
| 21502823 | Background | Nunez J, Cristofalo E, McGinley B, Katz R, Glen DR, Gauda E. Temporal association of polysomnographic cardiorespiratory events with GER detected by MII-pH probe in the premature infant at term. J Pediatr Gastroenterol Nutr. 2011 May;52(5):523-31. doi: 10.1097/MPG.0b013e3181fa06d7. |
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All results will be made available with other researchers on demand, upon reasonable requests
Available if requested, up to 2023
Similar study protocol
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Every baby was his own control (cross-over design)
The aim was to get at least 30 enrolled newborns to have more than 20 valid recordings.
We enrolled a total of 32 patients. 5 babies were withdrawed before recordings. This gave us 27 complete and analyzable recordings.
Patients were screened for eligibility and recruited in the neonatal care unit of the University of Sherbrooke Hospital Center, Canada, from November 2015 to February 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vanilla, Then no Vanilla Night | Intervention = exposition to vanilla scent A quantity of 2 ml of a saturated vanilla solution (2% vanillin) will be applied on premature pyjamas infant's, close to his face (on each shoulder and on the upper chest). Vanilla scent: A 12-hour continuous recording for monitoring hemoglobin oxygen saturation, electrocardiogram and respiratory movements will be performed while the infant is exposed to vanilla scent (from vanilla solution on the infant's pyjamas). In addition, a 3-hour polysomnography will be done in a sub-sample on the morning following the night recording with vanilla solution. |
| FG001 | No Vanilla, Then Vanilla Night | The only difference with the experimental arm is the absence of vanilla (usual, standard care) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (First Night) |
| |||||||||||||
| Washout, no Intervention (Second Night) |
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| Second Intervention (Third Night) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vanilla, Then no Vanilla Night | First night: exposition to vanilla scent and recordings A quantity of 2 ml of a saturated vanilla solution (2% vanillin) were applied on premature pyjamas infant's, close to the face (on each shoulder and on the upper chest). Second night: No interventions, no recordings were made Third night: Control night, no vanilla, recordings for 12 hours Recordings: A 12-hour continuous recording for monitoring hemoglobin oxygen saturation, electrocardiogram and respiratory movements were performed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Desaturation Index | Number per hour of oxygen saturation < 90% for at least 5 seconds | The population in each group consists of the total participants number (27), since all children were exposed to the vanilla odor on one night, and all children were exposed to the control treatment on another night. In other words, all children were both in the vanilla night group, and the control night group. | Posted | Mean | Standard Deviation | Number of events | 12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odor |
|
The period when adverse events was observed was during the 3 nights period.
The participants were observed for any clinical changes that could happen during the trial, over the 3 days. A close collaboration with the neonatal team was performed to monitor any impacts.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Night-vanilla | Intervention = exposition to vanilla scent A quantity of 2 ml of a saturated vanilla solution (2% vanillin) will be applied on premature pyjamas infant's, close to his face (on each shoulder and on the upper chest). Vanilla scent: A 12-hour continuous recording for monitoring hemoglobin oxygen saturation, electrocardiogram and respiratory movements will be performed while the infant is exposed to vanilla scent (from vanilla solution on the infant's pyjamas). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jean-Paul Praud | University of Sherbrooke Hospital Research Center, QC, Canada | 819-346-1110 | 14851 | jean-paul.praud@usherbrooke.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 13, 2015 | Aug 29, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Percent of time of the recording spent in periodic breathing or in apnea. A periodic beathing epoch was defined as a series of 3 episodes or more of apneas lasting at least 3 seconds and separated by less than 20 seconds of normal breathing Apneas were defined as the absence of respiratory movements for at least 20 seconds or for at least 2 breathing cycles with a decrease of at least 3% in SpO2 |
| 12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odor |
| Time in Apnea | Percent of time of the recording spent in apnea | 12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odor |
| Mean SpO2 | Mean value of oxygen saturation (%) | 12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odor |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | No Vanilla, Then Vanilla Night | First night: no exposition to vanilla scent, recordings (control night) Second night: No interventions, no recordings were made Third night: Vanilla exposition, with 2 ml of a saturated vanilla solution (2% vanillin) applied on premature pyjamas infant's, close to the face (on each shoulder and on the upper chest). Recordings for 12 hours Recordings: A 12-hour continuous recording for monitoring hemoglobin oxygen saturation, electrocardiogram and respiratory movements were performed. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gestational age | Median | Full Range | Weeks |
|
| Chronological age | Median | Full Range | Days |
|
| Caffeine | Number of participants that were being treated with caffeine at the time of the study. Prolonged apneas of prematurity and periodic breathing have been treated primarily with caffeine which, overall, is accepted as a safe respiratory stimulant at standard dosage, though it may have unwanted side effects and is not always efficient. | Count of Participants | Participants |
|
| Weight | Mean | Full Range | kg |
|
| OG001 | Night-no Vanilla | The only difference with the experimental arm is the absence of vanilla (usual, standard care) |
|
|
| Secondary | Percentage of Time of Oxygen Saturation Under 90% | Percentage time in overall duration of oxygen saturation under 90% | The population in each group consists of the total participants number (27), since all children were exposed to the vanilla odor on one night, and all children were exposed to the control treatment on another night. In other words, all children were both in the vanilla night group, and the control night group. | Posted | Mean | Standard Deviation | % of overall time | 12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odor |
|
|
|
| Secondary | Percentage of Time of Periodic Breathing | Percent of time of the recording spent in periodic breathing or in apnea. A periodic beathing epoch was defined as a series of 3 episodes or more of apneas lasting at least 3 seconds and separated by less than 20 seconds of normal breathing Apneas were defined as the absence of respiratory movements for at least 20 seconds or for at least 2 breathing cycles with a decrease of at least 3% in SpO2 | The number of usable recordings was 11 out of the 27, because the of technical recordings issues | Posted | Mean | Standard Deviation | % of overall time | 12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odor |
|
|
|
| Secondary | Time in Apnea | Percent of time of the recording spent in apnea | The number of usable recordings was 11 out of the 27, because the of technical recordings issues | Posted | Mean | Standard Deviation | % of overall time | 12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odor |
|
|
|
| Secondary | Mean SpO2 | Mean value of oxygen saturation (%) | Posted | Mean | Standard Deviation | % of SpO2 | 12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odor |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Night-no Vanilla | The only difference with the experimental arm is the absence of vanilla (usual, standard care) | 0 | 27 | 0 | 27 | 0 | 27 |
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| D000091642 | Urogenital Diseases |