Clinical trial NCT02630147: Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants
Official title: Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Neonatal Hypoxic Conditions
Keywords: Late preterm
Vanilla
Hypoxic intermittent events
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2015-12-15
Enrollment: 32
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Desaturation Index
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 odor
Secondary outcomes:
measure: Percentage of Time of Oxygen Saturation Under 90%
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 odor
measure: Percentage of Time of Periodic Breathing
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 odor
measure: Time in Apnea
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 odor
measure: Mean SpO2
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 odor
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Nicu - Chus
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Jean-Paul Praud, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.