Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants

Conditions
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Premature Birth, Neonatal Hypoxic Conditions

Intervention / Treatment
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* Other: Vanilla scent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Weeks
Maximum Age: 4 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vanilla, Then no vanilla night<br>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 | Other: Vanilla scent<br>* 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).<br>|
| Experimental: No vanilla, Then vanilla night<br>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 | Other: Vanilla scent<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Late preterm, Vanilla, Hypoxic intermittent events