Nasal olfactory stimulation (odor stimulation) and its effect on respiratory drive in preterm infants
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
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)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
Prof. Dirk Bassler, Neonatal Department, University Hospital Zurich
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Janine Thomann
+41796840280
janine.thomann@clutterusz.chNeonatal Department University Hospital Zurich
(BASEC)
Informazioni generali
Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland,
0041432538774;+41432538774
janine.thomann@clutterusz.ch(ICTRP)
Informazioni generali
Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland
(ICTRP)
Informazioni scientifiche
Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland,
0041432538774;+41432538774
janine.thomann@clutterusz.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
02.05.2023
(BASEC)
ID di studio ICTRP
NCT05878925 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Nasal Olfactory Stimulation and its Effect on Respiratory Drive in Preterm Infants - A Randomized Cross-over Study (BASEC)
Titolo accademico
Nasal Olfactory Stimulation and Its Effect on Respiratory Drive in Preterm Infants - A Randomized Cross-over Study (ICTRP)
Titolo pubblico
Nasal Olfactory Stimulation and Its Effect on Respiratory Drive in Preterm Infants (ICTRP)
Malattie studiate
Apnea of PrematurityPrematurityInfant, Premature, Diseases (ICTRP)
Intervento studiato
Other: AromaOther: Placebo (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
Bangerter-Rhyner Foundation (ICTRP)
Contatti aggiuntivi
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)
ID secondari
NOSE (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT05878925 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile