Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants

Université de Sherbrooke

Status: Completed

Conditions: Premature Birth; Neonatal Hypoxic Conditions

Treatments: Other: Vanilla scent

Study type: Interventional

Funder types: Other

Identifiers

NCT02630147

2016-1043

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 3 to 4 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Vanilla, Then no vanilla night

Experimental group

Description:

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

Treatment:

Other: Vanilla scent

No vanilla, Then vanilla night

Experimental group

Description:

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

Treatment:

Other: Vanilla scent