Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants

Premature Birth Clinical Trial

— Vanilla  

Official title:

Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02630147
• Other study ID #: 2016-1043
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: June 2019

Study information

• Verified date: August 2022
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Weeks to 4 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Hypoxia
• Neonatal Hypoxic Conditions
• Premature Birth

Intervention

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).

Locations

Country	Name	City	State
Canada	Nicu - Chus	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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