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Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants — Vanilla  

Premature Birth Clinical Trial

Official title:
Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02630147
Study type Interventional
Source Université de Sherbrooke
Contact
Status Completed
Phase N/A
Start date November 2015
Completion date June 2019
View Details
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