Nasal olfactory stimulation (odor stimulation) and its effect on respiratory drive in preterm infants
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
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)
Studienstandort
Zürich
(BASEC)
Sponsor
Prof. Dirk Bassler, Neonatal Department, University Hospital Zurich
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Janine Thomann
+41796840280
janine.thomann@clutterusz.chNeonatal Department University Hospital Zurich
(BASEC)
Allgemeine Auskünfte
Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland,
0041432538774;+41432538774
janine.thomann@clutterusz.ch(ICTRP)
Allgemeine Auskünfte
Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland
(ICTRP)
Wissenschaftliche Auskünfte
Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland,
0041432538774;+41432538774
janine.thomann@clutterusz.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
02.05.2023
(BASEC)
ICTRP Studien-ID
NCT05878925 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Nasal Olfactory Stimulation and its Effect on Respiratory Drive in Preterm Infants - A Randomized Cross-over Study (BASEC)
Wissenschaftlicher Titel
Nasal Olfactory Stimulation and Its Effect on Respiratory Drive in Preterm Infants - A Randomized Cross-over Study (ICTRP)
Öffentlicher Titel
Nasal Olfactory Stimulation and Its Effect on Respiratory Drive in Preterm Infants (ICTRP)
Untersuchte Krankheit(en)
Apnea of PrematurityPrematurityInfant, Premature, Diseases (ICTRP)
Untersuchte Intervention
Other: AromaOther: Placebo (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Bangerter-Rhyner Foundation (ICTRP)
Weitere Kontakte
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)
Sekundäre IDs
NOSE (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT05878925 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar