Skip to main content
OpenTrials
Completed

NCT Number: NCT02630147

Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Neonatal Hypoxic Conditions Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

3 week–4 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nicu - Chus

Sherbrooke, Quebec, J1H5N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vanilla scent

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).

Primary outcomes

  1. Desaturation Index

    Time frame: 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

    Number per hour of oxygen saturation < 90% for at least 5 seconds

Secondary outcomes

  1. Percentage of Time of Oxygen Saturation Under 90%

    Time frame: 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 time in overall duration of oxygen saturation under 90%

  2. Percentage of Time of Periodic Breathing

    Time frame: 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

    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

  3. Time in Apnea

    Time frame: 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

    Percent of time of the recording spent in apnea

  4. Mean SpO2

    Time frame: 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 value of oxygen saturation (%)

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Acronym: Vanilla

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 15, 2015
Registry last updated
Jul 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.