Nasal olfactory stimulation (odor stimulation) and its effect on respiratory drive in preterm infants
Résumé de l'étude
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 étudiée
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)
Maladie en cours d'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)
Critères d'exclusion
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)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
Prof. Dirk Bassler, Neonatal Department, University Hospital Zurich
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Janine Thomann
+41796840280
janine.thomann@clutterusz.chNeonatal Department University Hospital Zurich
(BASEC)
Informations générales
Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland,
0041432538774;+41432538774
janine.thomann@clutterusz.ch(ICTRP)
Informations générales
Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland
(ICTRP)
Informations scientifiques
Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland,
0041432538774;+41432538774
janine.thomann@clutterusz.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
02.05.2023
(BASEC)
Identifiant de l'essai ICTRP
NCT05878925 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Nasal Olfactory Stimulation and its Effect on Respiratory Drive in Preterm Infants - A Randomized Cross-over Study (BASEC)
Titre académique
Nasal Olfactory Stimulation and Its Effect on Respiratory Drive in Preterm Infants - A Randomized Cross-over Study (ICTRP)
Titre public
Nasal Olfactory Stimulation and Its Effect on Respiratory Drive in Preterm Infants (ICTRP)
Maladie en cours d'investigation
Apnea of PrematurityPrematurityInfant, Premature, Diseases (ICTRP)
Intervention étudiée
Other: AromaOther: Placebo (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
Bangerter-Rhyner Foundation (ICTRP)
Contacts supplémentaires
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 secondaires
NOSE (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05878925 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible