Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants
Nyckelord
Abstrakt
Beskrivning
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 consult 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.
A 3h polysomnography will be done in a sub-sample of 10-15 infants in the morning by the night 1 and 3 according by the pre-existing condition of vanilla or not.
All data will be entered in a secured database and a double checked will be done by team members to assess the accuracy.
Datum
| Senast verifierad: | 06/30/2019 |
| Först skickat: | 12/03/2015 |
| Beräknad anmälan inlämnad: | 12/13/2015 |
| Först publicerad: | 12/14/2015 |
| Senaste uppdatering skickad: | 07/10/2019 |
| Senaste uppdatering publicerad: | 07/14/2019 |
| Faktiskt startdatum för studien: | 08/31/2015 |
| Uppskattat primärt slutdatum: | 11/30/2019 |
| Beräknat slutfört datum: | 05/31/2020 |
Tillstånd eller sjukdom
Intervention / behandling
Other: Night-vanilla
Fas
Armgrupper
| Ärm | Intervention / behandling |
|---|---|
| Experimental: Night-vanilla Intervention = exposition to vanilla scent A quantity of 2 ml of a saturated vanilla solution (2% vanillin) will be applied on premature pyjamas infant's, close to his face (on each shoulder and on the upper chest). | Other: Night-vanilla 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).
In addition, a 3-hour polysomnography will be done in a sub-sample on the morning following the night recording with vanilla solution. |
| No Intervention: Night-no vanilla The only difference with the experimental arm is the absence of vanilla (usual, standard care) |
Urvalskriterier
| Kön som är berättigade till studier | All |
| Accepterar friska volontärer | Ja |
| Kriterier | Inclusion Criteria: - Infants born between 32.0 and 33.6 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. |
Resultat
Primära resultatåtgärder
1. Number of hypoxic intermittent events [night 1 and 3]
Sekundära resultatåtgärder
1. Duration of oxygen saturation under 80% and under 90% [night 1 and 3]
2. Number of bradycardias [night 1 and 3]
3. Duration of periodic breathing [night 1 and 3]
4. Heart rate variability [night 1 and 3]
5. Respiratory rate variability [night 1 and 3]
