Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02630147

Acronym

Vanilla

Enrollment

Registered

2015-12-15

Start date

2015-11-30

Completion date

2019-06-30

Last updated

2023-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Hypoxic Conditions, Premature Birth

Keywords

Late preterm, Vanilla, Hypoxic intermittent events

Brief summary

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.

Detailed description

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.

Interventions

OTHERVanilla 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).

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Weeks to 4 Weeks

Healthy volunteers

Inclusion criteria

* Infants born between 30.0 and 34.0 weeks of gestational age; * Postnatal age between 3 and 4 weeks; * No current respiratory or ventilatory support; * Stable state for at least the last 48 hours; * Parental consent to enroll in the study.

Exclusion criteria

* Respiratory diseases other than apnea; * Intraventricular hemorrhage grade 3 or 4 OR leukomalacia; * Chromosomal abnormality; * Congenital malformations which may result in cardiorespiratory or neurodevelopmental abnormality; * Clinical deterioration during the study.

Design outcomes

Primary

Measure	Time frame	Description
Desaturation Index	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	Number per hour of oxygen saturation \< 90% for at least 5 seconds

Secondary

Measure	Time frame	Description
Percentage of Time 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 time in overall duration of oxygen saturation under 90%
Percentage of Time of Periodic Breathing	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	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
Time 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	Percent of time of the recording spent in apnea
Mean 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	Mean value of oxygen saturation (%)

Countries

Canada

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

Arm	Count
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.	14
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.	13
Total	27

Baseline characteristics

Characteristic	No Vanilla, Then Vanilla Night	Vanilla, Then no Vanilla Night	Total
Age, Categorical <=18 years	13 Participants	14 Participants	27 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Age, Continuous	23.93 Days STANDARD_DEVIATION 3.61	24.57 Days STANDARD_DEVIATION 4.48	24.26 Days STANDARD_DEVIATION 4.02
Caffeine	10 Participants	13 Participants	23 Participants
Chronological age	25 Days	23 Days	24 Days
Gestational age	32 Weeks	32 Weeks	32 Weeks
Race and Ethnicity Not Collected	—	—	0 Participants
Region of Enrollment Canada	13 participants	14 participants	27 participants
Sex: Female, Male Female	3 Participants	8 Participants	11 Participants
Sex: Female, Male Male	10 Participants	6 Participants	16 Participants
Weight	1.75 kg	1.595 kg	1.67 kg

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 27	0 / 27
other Total, other adverse events	0 / 27	0 / 27
serious Total, serious adverse events	0 / 27	0 / 27