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Nasal Olfactory Stimulation and Its Effect on Respiratory Drive in Preterm Infants

Recruiting
72 years of age
Both
Phase N/A

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Overview

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

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

Study details

Apnea of Prematurity, Prematurity, Infant, Premature, Diseases

NCT05878925

University of Zurich

25 January 2024

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