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

NCT ID: NCT05878925

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-14
• Study Completion Date: 2025-01-24

Brief Summary

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.

Conditions

Apnea of Prematurity; Prematurity; Infant, Premature, Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Aroma

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.

Group Type: EXPERIMENTAL

Aroma

Intervention Type: OTHER

The study intervention is an olfactory stimulation with vanilla or strawberry aroma. The aroma will be applied to the inner surface of the nCPAP mask of preterm infants using designated scent pens every 3-4 hours over a period of 12 hours. The two aromas will be applied in blocks of 5 consecutive infants (5 infants vanilla, 5 infants strawberry, and so forth).

Control

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

During the control intervention, identically looking placebo pens will be used to apply a colored carrier solution (without aroma) to the inner surface of the nCPAP mask of preterm infants in the same manner.

Interventions

Aroma

The study intervention is an olfactory stimulation with vanilla or strawberry aroma. The aroma will be applied to the inner surface of the nCPAP mask of preterm infants using designated scent pens every 3-4 hours over a period of 12 hours. The two aromas will be applied in blocks of 5 consecutive infants (5 infants vanilla, 5 infants strawberry, and so forth).

Intervention Type: OTHER

Placebo

During the control intervention, identically looking placebo pens will be used to apply a colored carrier solution (without aroma) to the inner surface of the nCPAP mask of preterm infants in the same manner.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 72 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bangerter-Rhyner Foundation

UNKNOWN

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janine Thomann, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland

Locations

Department of Neonatology, Newborn Research, University Hospital and University of Zurich,

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

NOSE

Identifier Type: -

Identifier Source: org_study_id