Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants

NCT02630147 | Completed Results DMC

• 1 other identifier: 2016-1043
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth; Neonatal Hypoxic Conditions

Keywords

Late preterm; Vanilla; Hypoxic intermittent events

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Percentage of Time 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

  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

  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

  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

Study Arms (2)

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

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

Other: Vanilla scent

Interventions

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).

No vanilla, Then vanilla night; Vanilla, Then no vanilla night

Eligibility Criteria

• Age: 3 Weeks - 4 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Nicu - Chus

Sherbrooke, Quebec, J1H5N4, Canada

Location

Related 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.

  PMID: 24211071 BACKGROUND

• 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.

  PMID: 21502823 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Dr Jean-Paul Praud
• Organization: University of Sherbrooke Hospital Research Center, QC, Canada

jean-paul.praud@usherbrooke.ca

819-346-1110

Study Officials

• Jean-Paul Praud, MD, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: December 15, 2015
• Study Start: November 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: July 17, 2023
• Results First Posted: July 17, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Available if requested, up to 2023
• Access Criteria: Similar study protocol

Locations

CA (1)