Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants (Vanilla)

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.

Study Overview

• Status: Completed
• Conditions: Premature Birth; Neonatal Hypoxic Conditions
• Intervention / Treatment: Other: Vanilla scent

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Paul Praud, MD, PhD; Phone Number: 14851 819-346-1110; Email: jean-paul.praud@usherbrooke.ca

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H5N4
      • Nicu - Chus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 weeks to 4 weeks (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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).
Experimental: 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	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Desaturation Index	Number per hour of oxygen saturation < 90% for at least 5 seconds	12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odor

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Time of Oxygen Saturation Under 90%	Percentage time in overall duration of oxygen saturation under 90%	12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odor
Percentage of Time of Periodic Breathing	Percent of time of the recording spent in periodic breathing or in apnea. A periodic beathing epoch was defined as a series of 3 episodes or more of apneas lasting at least 3 seconds and separated by less than 20 seconds of normal breathing Apneas were defined as the absence of respiratory movements for at least 20 seconds or for at least 2 breathing cycles with a decrease of at least 3% in SpO2	12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odor
Time in Apnea	Percent of time of the recording spent in apnea	12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odor
Mean SpO2	Mean value of oxygen saturation (%)	12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odor

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Investigators: Principal Investigator: Jean-Paul Praud, MD, PhD, Université de Sherbrooke

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: J Pediatr Gastroenterol Nutr. 2011 Jun;52(6):787.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: December 4, 2015
• First Submitted That Met QC Criteria: December 14, 2015
• First Posted (Estimated): December 15, 2015

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Late preterm; Vanilla; Hypoxic intermittent events
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Hypoxia
• Other Study ID Numbers: 2016-1043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All results will be made available with other researchers on demand, upon reasonable requests
• IPD Sharing Time Frame: Available if requested, up to 2023
• IPD Sharing Access Criteria: Similar study protocol
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR