Nasal olfactory stimulation (odor stimulation) and its effect on respiratory drive in preterm infants
Summary description of the study
As part of the NOSE study, we aim to stimulate the breathing of preterm infants with food scents using two different aromas. We want to find out whether and how strongly stimulation with vanilla or strawberry scent may reduce the occurrence of drops in oxygen saturation and heart rate. The NOSE study will be conducted at the neonatal clinic of the University Hospital Zurich.
(BASEC)
Intervention under investigation
During two phases of 12 hours, the respiratory mask of the preterm infants will be rubbed every 3-4 hours with a pen containing either a fragrance (vanilla or strawberry) or a placebo. Randomization will determine which child receives vanilla or strawberry scent and whether the scent pen or the placebo pen is used first. There is a 12-hour break between the two measurement phases.
(BASEC)
Disease under investigation
Apneas in preterm infants that can lead to drops in oxygen saturation and heart rate
(BASEC)
To participate in the NOSE study, the preterm infant must • be born between 23 and 32 weeks of gestation, • be at least 3 days old at the time of the study • be supported by CPAP (continuous positive airway pressure via a mask) and receive a medication therapy with caffeine. (BASEC)
Exclusion criteria
Children with congenital malformations that limit life expectancy Congenital severe olfactory disorders An acute severe illness (e.g., an infection) during the duration of the study (BASEC)
Trial sites
Zurich
(BASEC)
Sponsor
Prof. Dirk Bassler, Neonatal Department, University Hospital Zurich
(BASEC)
Contact
Contact Person Switzerland
Janine Thomann
+41796840280
janine.thomann@clutterusz.chNeonatal Department University Hospital Zurich
(BASEC)
General Information
Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland,
0041432538774;+41432538774
janine.thomann@clutterusz.ch(ICTRP)
General Information
Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland
(ICTRP)
Scientific Information
Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland,
0041432538774;+41432538774
janine.thomann@clutterusz.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
02.05.2023
(BASEC)
ICTRP Trial ID
NCT05878925 (ICTRP)
Official title (approved by ethics committee)
Nasal Olfactory Stimulation and its Effect on Respiratory Drive in Preterm Infants - A Randomized Cross-over Study (BASEC)
Academic title
Nasal Olfactory Stimulation and Its Effect on Respiratory Drive in Preterm Infants - A Randomized Cross-over Study (ICTRP)
Public title
Nasal Olfactory Stimulation and Its Effect on Respiratory Drive in Preterm Infants (ICTRP)
Disease under investigation
Apnea of PrematurityPrematurityInfant, Premature, Diseases (ICTRP)
Intervention under investigation
Other: AromaOther: Placebo (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Inclusion/Exclusion 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 (ICTRP)
not available
Primary and secondary end points
Paired difference in the combined number of desaturations and bradycardia (ICTRP)
Paired difference in fraction of inspired oxygen (FiO2);Paired difference in mean peripheral oxygen saturation;Paired difference in time spent with peripheral oxygen saturations <80%;Paired difference in time spent with heart rate <80 bpm;Paired difference in mean respiratory rate (as counted by nurses and manually) documented according to clinical routine) and heart rate;Paired difference in the apnea score documented by nurses;Paired difference in desaturations requiring stimulation or increase in FiO2;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) (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
Bangerter-Rhyner Foundation (ICTRP)
Additional contacts
Janine Thomann, MD;Janine Thomann, MD;Janine Thomann, MD, janine.thomann@usz.ch, 0041432538774;+41432538774, Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland, (ICTRP)
Secondary trial IDs
NOSE (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT05878925 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available