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

University of Zurich (UZH)

Status: Completed

Conditions: Infant, Premature, Diseases; Prematurity; Apnea of Prematurity

Treatments: Other: Placebo; Other: Aroma

Study type: Interventional

Funder types: Other

Identifiers

NCT05878925

NOSE

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 72+ hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Aroma

Experimental group

Description:

Preterm infants on CPAP support will be exposed to either vanilla or strawberry aroma. A pen with and without vanilla or strawberry aroma will be used to apply the aroma to the inner surface of the CPAP mask.

Treatment:

Other: Aroma

Control

Placebo Comparator group

Description:

Preterm infants on CPAP support will be exposed to placebo. The placebo pen will contain the carrier solution and natural coloring agents but no aroma.

Treatment:

Other: Placebo