Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Vanilla, Then no vanilla night	Vanilla scent	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	Vanilla scent	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 (%)