Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants

NCT ID: NCT02630147

Last Updated: 2023-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2019-06-30

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.

Conditions

Premature Birth; Neonatal Hypoxic Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vanilla, Then no vanilla night

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

Group Type: EXPERIMENTAL

Vanilla scent

Intervention Type: OTHER

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).

No vanilla, Then vanilla night

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

Group Type: EXPERIMENTAL

Vanilla scent

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 3 Weeks
• Maximum Eligible Age: 4 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Jean-Paul Praud

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean-Paul Praud, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

Nicu - Chus

Sherbrooke, Quebec, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 24211071 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21502823 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016-1043

Identifier Type: -

Identifier Source: org_study_id