Premature BirthVanillaNCT02630147
Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants
A study testing Vanilla scent in people with Premature Birth and Neonatal Hypoxic Conditions, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 4 weeks
- Conditions the study is for
- Premature Birth, Neonatal Hypoxic Conditions
- What is being tested?
- Vanilla scent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 4 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Vanilla scent
- Keywords
- Late preterm, Vanilla, Hypoxic intermittent events
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vanilla scentOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Vanilla, Then no vanilla night | Experimental | 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 Receives: Other: Vanilla scent |
| No vanilla, Then vanilla night | Experimental | 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 Receives: Other: Vanilla scent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desaturation Index
Number per hour of oxygen saturation < 90% for at least 5 seconds
Measured: 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 outcomes (4)
Percentage of Time of Oxygen Saturation Under 90%
Percentage time in overall duration of oxygen saturation under 90%
Measured: 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
Measured: 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
Measured: 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 (%)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Paul Praud, Université de Sherbrooke
- Investigators
- Jean-Paul Praud, MD, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630147
- Sponsor's protocol ID
- 2016-1043
- Acronym
- Vanilla
- Status last verified
- Aug 2022
- First submitted
- 4 Dec 2015
- Last updated
- 17 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: All results will be made available with other researchers on demand, upon reasonable requests
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.
PubMed 24211071Nunez 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.
PubMed 21502823
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants
- ClinicalTrials.gov ID
- NCT02630147
- Acronym / sponsor ID
- Vanilla / 2016-1043
- Conditions
- Premature Birth, Neonatal Hypoxic Conditions
- Keywords
- Late preterm, Vanilla, Hypoxic intermittent events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 15 Dec 2015 (estimated)
- Results
- Posted 17 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vanilla, Then no vanilla night | Experimental | Other: Vanilla scentParticipants 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 |
| No vanilla, Then vanilla night | Experimental | Other: Vanilla scentParticipants 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 |
Who may qualify
- Ages
- 3 to 4 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vanilla scentA 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). | Other | No vanilla, Then vanilla night, Vanilla, Then no vanilla night |
Primary outcome
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
4 secondary outcomes
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 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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24211071Brockmann 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.
- Background: PubMed 21502823Nunez 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.
- Individual participant dataSharing planned: Yes. All results will be made available with other researchers on demand, upon reasonable requests
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Paul Praud, MD, PhD principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vanilla scent in people with Premature Birth and Neonatal Hypoxic Conditions, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02630147, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.