Trial Outcomes & Findings for Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants (NCT NCT02630147)
NCT ID: NCT02630147
Last Updated: 2023-07-17
Results Overview
Number per hour of oxygen saturation \< 90% for at least 5 seconds
COMPLETED
NA
32 participants
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
2023-07-17
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
No Vanilla, Then Vanilla Night
The only difference with the experimental arm is the absence of vanilla (usual, standard care)
|
|---|---|---|
|
First Intervention (First Night)
STARTED
|
14
|
13
|
|
First Intervention (First Night)
COMPLETED
|
14
|
13
|
|
First Intervention (First Night)
NOT COMPLETED
|
0
|
0
|
|
Washout, no Intervention (Second Night)
STARTED
|
14
|
13
|
|
Washout, no Intervention (Second Night)
COMPLETED
|
14
|
13
|
|
Washout, no Intervention (Second Night)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (Third Night)
STARTED
|
14
|
13
|
|
Second Intervention (Third Night)
COMPLETED
|
14
|
13
|
|
Second Intervention (Third Night)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Vanilla, Then no Vanilla Night
n=14 Participants
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.
|
No Vanilla, Then Vanilla Night
n=13 Participants
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.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=14 Participants
|
13 Participants
n=13 Participants
|
27 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=14 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=14 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
24.57 Days
STANDARD_DEVIATION 4.48 • n=14 Participants
|
23.93 Days
STANDARD_DEVIATION 3.61 • n=13 Participants
|
24.26 Days
STANDARD_DEVIATION 4.02 • n=27 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=14 Participants
|
3 Participants
n=13 Participants
|
11 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=14 Participants
|
10 Participants
n=13 Participants
|
16 Participants
n=27 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
14 participants
n=14 Participants
|
13 participants
n=13 Participants
|
27 participants
n=27 Participants
|
|
Gestational age
|
32 Weeks
n=14 Participants
|
32 Weeks
n=13 Participants
|
32 Weeks
n=27 Participants
|
|
Chronological age
|
23 Days
n=14 Participants
|
25 Days
n=13 Participants
|
24 Days
n=27 Participants
|
|
Caffeine
|
13 Participants
n=14 Participants
|
10 Participants
n=13 Participants
|
23 Participants
n=27 Participants
|
|
Weight
|
1.595 kg
n=14 Participants
|
1.75 kg
n=13 Participants
|
1.67 kg
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odorPopulation: 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.
Number per hour of oxygen saturation \< 90% for at least 5 seconds
Outcome measures
| Measure |
Night-vanilla
n=27 Participants
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).
|
Night-no Vanilla
n=27 Participants
The only difference with the experimental arm is the absence of vanilla (usual, standard care)
|
|---|---|---|
|
Desaturation Index
|
51.7 Number of events
Standard Deviation 22.0
|
56.9 Number of events
Standard Deviation 25.7
|
SECONDARY outcome
Timeframe: 12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odorPopulation: 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.
Percentage time in overall duration of oxygen saturation under 90%
Outcome measures
| Measure |
Night-vanilla
n=27 Participants
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).
|
Night-no Vanilla
n=27 Participants
The only difference with the experimental arm is the absence of vanilla (usual, standard care)
|
|---|---|---|
|
Percentage of Time of Oxygen Saturation Under 90%
|
1.8 % of overall time
Standard Deviation 1.23
|
2.2 % of overall time
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odorPopulation: The number of usable recordings was 11 out of the 27, because the of technical recordings issues
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
Outcome measures
| Measure |
Night-vanilla
n=11 Participants
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).
|
Night-no Vanilla
n=11 Participants
The only difference with the experimental arm is the absence of vanilla (usual, standard care)
|
|---|---|---|
|
Percentage of Time of Periodic Breathing
|
12.2 % of overall time
Standard Deviation 12.4
|
8.7 % of overall time
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: 12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odorPopulation: The number of usable recordings was 11 out of the 27, because the of technical recordings issues
Percent of time of the recording spent in apnea
Outcome measures
| Measure |
Night-vanilla
n=11 Participants
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).
|
Night-no Vanilla
n=11 Participants
The only difference with the experimental arm is the absence of vanilla (usual, standard care)
|
|---|---|---|
|
Time in Apnea
|
0.99 % of overall time
Standard Deviation 0.4
|
1.02 % of overall time
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odorMean value of oxygen saturation (%)
Outcome measures
| Measure |
Night-vanilla
n=27 Participants
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).
|
Night-no Vanilla
n=27 Participants
The only difference with the experimental arm is the absence of vanilla (usual, standard care)
|
|---|---|---|
|
Mean SpO2
|
98 % of SpO2
Standard Deviation 1.2
|
97.5 % of SpO2
Standard Deviation 1.5
|
Adverse Events
Night-vanilla
Night-no Vanilla
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Jean-Paul Praud
University of Sherbrooke Hospital Research Center, QC, Canada
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place