NCT02630147

Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Université de Sherbrooke · Academic / Other
• Sex: All
• Age: 3 Weeks – 4 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Premature Birth
• Neonatal Hypoxic Conditions

Interventions

Type	Name	Description
OTHER	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).

Timeline

• Start date: 2015-11-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2015-12-15
• Last updated: 2023-07-17
• Results posted: 2023-07-17

Locations

1 site across 1 country: Canada