Clinical trial NCT05878925: Nasal Olfactory Stimulation and Its Effect on Respiratory Drive in Preterm Infants
Official title: Nasal Olfactory Stimulation and Its Effect on Respiratory Drive in Preterm Infants - A Randomized Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apnea of Prematurity
Prematurity
Infant, Premature, Diseases
Keywords: Olfactory stimulation
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Bangerter-Rhyner Foundation
First posted: 2023-05-30
Enrollment: 80
Sex: ALL
Minimum age (years): 72
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Paired difference in the combined number of desaturations and bradycardia
timeFrame: 12-hour recording periods for each intervention
Secondary outcomes:
measure: Paired difference in fraction of inspired oxygen (FiO2)
timeFrame: 12-hour recording periods for each intervention
measure: Paired difference in mean peripheral oxygen saturation
timeFrame: 12-hour recording periods for each intervention
measure: Paired difference in time spent with peripheral oxygen saturations <80%
timeFrame: 12-hour recording periods for each intervention
measure: Paired difference in time spent with heart rate <80 bpm
timeFrame: 12-hour recording periods for each intervention
measure: Paired difference in mean respiratory rate (as counted by nurses and manually) documented according to clinical routine) and heart rate
timeFrame: 12-hour recording periods for each intervention
measure: Paired difference in the apnea score documented by nurses
timeFrame: 12-hour recording periods for each intervention
measure: Paired difference in desaturations requiring stimulation or increase in FiO2
timeFrame: 12-hour recording periods for each intervention
measure: 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)
timeFrame: 12-hour recording periods for each intervention
Other outcomes:
measure: Prespecified subgroup analyses of the primary outcome will be performed according to the type of aroma (vanilla or strawberry) that was administered.
timeFrame: 12-hour recording periods for each intervention
Locations:
city: Zürich
country: Switzerland
facility: Department of Neonatology, Newborn Research, University Hospital and University of Zurich,
Study officials:
affiliation: Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland
name: Janine Thomann, MD
role: PRINCIPAL_INVESTIGATOR
References: