Nasal Olfactory Stimulation and Its Effect on Respiratory Drive in Preterm Infants - A Randomized Cross-over Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Apnea of Prematurity
- Sponsor
- University of Zurich
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Paired difference in the combined number of desaturations and bradycardia
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This trial analyzes the effect of an olfactory stimulation with vanilla or strawberry aroma compared to placebo on desaturations and bradycardia in preterm infants with apnea of prematurity. Infants on continuous positive airway pressure (CPAP) support will be included and the aroma will be applied to the inner surface of the CPAP mask using designated scent pens. The trial uses a cross-over design. Infants are randomised to begin the study with either aroma or placebo which will be applied into the breathing mask every 3 to 4 hours during 12 hours for each of the two intervention periods. Identically looking pens with either aroma or placebo are used and patients, parents, medical staff and the study team are blinded to this allocation. Infants are monitored with an oximetry sensor to measure peripheral oxygen saturation (SpO2) and pulse rate.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Gestational age at birth: 23 0/7 to 31 6/7 weeks
- •Postnatal age: \>72 hours old
- •Respiratory support: nCPAP
- •Treatment with caffeine citrate for apnea of prematurity
- •Written informed consent by one of the patient's parents
Exclusion Criteria
- •Olfactory impairment such as choanal atresia
- •Intraparenchymal intracranial hemorrhage or intraventricular hemorrhage with ventricular dilation
- •Culture-proven sepsis during the study period or any acute clinical deterioration requiring an intervention such as intubation or a new start of antibiotic treatment.
- •Severe congenital malformation adversely affecting life expectancy
Outcomes
Primary Outcomes
Paired difference in the combined number of desaturations and bradycardia
Time Frame: 12-hour recording periods for each intervention
A desaturation is defined as a fall in the SpO2 to \<80% for more than 10 seconds, a bradycardia is defined as a fall in heart rate \<80 bpm for more than 10 seconds. Desaturation episodes and bradycardia separated by a time interval of five seconds or less will be counted as a single event. A desaturation episode as part of a bradycardia (or vice versa) will be counted as a two events. Peripheral oxygen saturation and heart rate will be monitored with an oximeter sensor placed around the infants' wrist or ankle and connected to the oximeter in 2 seconds averaging mode and maximum sensitivity.
Secondary Outcomes
- Paired difference in time spent with heart rate <80 bpm(12-hour recording periods for each intervention)
- Paired difference in mean respiratory rate (as counted by nurses and manually) documented according to clinical routine) and heart rate(12-hour recording periods for each intervention)
- Paired difference in time spent with peripheral oxygen saturations <80%(12-hour recording periods for each intervention)
- Paired difference in desaturations requiring stimulation or increase in FiO2(12-hour recording periods for each intervention)
- Paired difference in fraction of inspired oxygen (FiO2)(12-hour recording periods for each intervention)
- Paired difference in mean peripheral oxygen saturation(12-hour recording periods for each intervention)
- Paired difference in the apnea score documented by nurses(12-hour recording periods for each intervention)
- Paired difference in tolerance of enteral nutrition as assessed by gastric residuals (the amount of stomach liquid detected prior to the next meal, in mL)(12-hour recording periods for each intervention)