N/A
Completed N=27
Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants
Premature Birth · Neonatal Hypoxic Conditions
Source: ClinicalTrials.gov NCT02630147 ↗
Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcomePrimary: Desaturation Index — 51.7; 56.9 Number of events
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.
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 | — |
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. Informational only — not medical advice.