N/A
N=27
Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants
Premature Birth · Neonatal Hypoxic Conditions
Bottom Line
View on ClinicalTrials.gov: NCT02630147 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Desaturation Index — 51.7; 56.9 Number of events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vanilla scent (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Université de Sherbrooke
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Desaturation Index |
51.7; 56.9 | — |
| SECONDARY Percentage of Time of Oxygen Saturation Under 90% |
1.8; 2.2 | — |
| SECONDARY Percentage of Time of Periodic Breathing |
12.2; 8.7 | — |
| SECONDARY Time in Apnea |
0.99; 1.02 | — |
| SECONDARY Mean SpO2 |
98; 97.5 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02630147). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.