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

Primary Purpose

Apnea of Prematurity, Prematurity, Infant, Premature, Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Aroma
Placebo
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apnea of Prematurity focused on measuring Olfactory stimulation

Eligibility Criteria

72 Hours - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aroma

Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

Paired difference in the combined number of desaturations and bradycardia
A desaturation is defined as a fall in the SpO2 to <80% for more than 10 seconds, a bradycardia is defined as a fall in heart rate <80 bpm for more than 10 seconds. Desaturation episodes and bradycardia separated by a time interval of five seconds or less will be counted as a single event. A desaturation episode as part of a bradycardia (or vice versa) will be counted as a two events. Peripheral oxygen saturation and heart rate will be monitored with an oximeter sensor placed around the infants' wrist or ankle and connected to the oximeter in 2 seconds averaging mode and maximum sensitivity.

Secondary Outcome Measures

Paired difference in fraction of inspired oxygen (FiO2)
Paired difference in oxygen requirement between the two intervention periods. The FiO2 will be measured by the infant ventilator and documented in the patient data management system
Paired difference in mean peripheral oxygen saturation
Paired difference in oxygen saturation between the two intervention periods. Peripheral oxygen saturation and heart rate will be monitored with an oximeter sensor placed around the infants' wrist or ankle and connected to the oximeter in 2 seconds averaging mode and maximum sensitivity.
Paired difference in time spent with peripheral oxygen saturations <80%
Paired difference in total time spent with an oxygen saturation <80% between intervention periods. Peripheral oxygen saturation and heart rate will be monitored with an oximeter sensor placed around the infants' wrist or ankle and connected to the oximeter in 2 seconds averaging mode and maximum sensitivity.
Paired difference in time spent with heart rate <80 bpm
Paired difference in total time spent with a heart rate <80 beats per minute between intervention periods. Peripheral oxygen saturation and heart rate will be monitored with an oximeter sensor placed around the infants' wrist or ankle and connected to the oximeter in 2 seconds averaging mode and maximum sensitivity.
Paired difference in mean respiratory rate (as counted by nurses and manually) documented according to clinical routine) and heart rate
Paired difference in mean respiratory rate between intervention periods. Respiratory rate will be counted and documented by nurses every 4 to 8 hours according to clinical standard and documented in the patient data management system.
Paired difference in the apnea score documented by nurses
Paired difference in the apnea score (objective scoring system for the number and severity of apneas during a dedicated time frame) between intervention periods. Definition of the apnea score: Cumulative number of bradycardia <80 bpm and desaturations <80% during sleep and unimpaired wakefulness. Score 1 for event without need for intervention, score 2 for event requiring tactile stimulation, score 3 for event requiring increase of FiO2, score 8 for event requiring mask ventilation.
Paired difference in desaturations requiring stimulation or increase in FiO2
Paired difference in the total number of desaturations requiring manual stimulation or an increase in supplemental oxygen between intervention periods. Manual stimulation will be documented by nurses in the patient data management system.
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)
Paired difference in amount of gastric residuals (mL) between intervention periods. Before each feed, nurses routinely aspirate orogastric tubes to check for the liquid volume and document the amount in mL in the patient data management system.

Full Information

First Posted
May 1, 2023
Last Updated
July 25, 2023
Sponsor
University of Zurich
Collaborators
Bangerter-Rhyner Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05878925
Brief Title
Nasal Olfactory Stimulation and Its Effect on Respiratory Drive in Preterm Infants
Acronym
NOSE
Official Title
Nasal Olfactory Stimulation and Its Effect on Respiratory Drive in Preterm Infants - A Randomized Cross-over Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2023 (Actual)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Bangerter-Rhyner Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apnea of Prematurity, Prematurity, Infant, Premature, Diseases
Keywords
Olfactory stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
To blind the study team and the medical team, identically looking pens will be provided with and without vanilla or strawberry aroma.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aroma
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Aroma
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Paired difference in the combined number of desaturations and bradycardia
Description
A desaturation is defined as a fall in the SpO2 to <80% for more than 10 seconds, a bradycardia is defined as a fall in heart rate <80 bpm for more than 10 seconds. Desaturation episodes and bradycardia separated by a time interval of five seconds or less will be counted as a single event. A desaturation episode as part of a bradycardia (or vice versa) will be counted as a two events. Peripheral oxygen saturation and heart rate will be monitored with an oximeter sensor placed around the infants' wrist or ankle and connected to the oximeter in 2 seconds averaging mode and maximum sensitivity.
Time Frame
12-hour recording periods for each intervention
Secondary Outcome Measure Information:
Title
Paired difference in fraction of inspired oxygen (FiO2)
Description
Paired difference in oxygen requirement between the two intervention periods. The FiO2 will be measured by the infant ventilator and documented in the patient data management system
Time Frame
12-hour recording periods for each intervention
Title
Paired difference in mean peripheral oxygen saturation
Description
Paired difference in oxygen saturation between the two intervention periods. Peripheral oxygen saturation and heart rate will be monitored with an oximeter sensor placed around the infants' wrist or ankle and connected to the oximeter in 2 seconds averaging mode and maximum sensitivity.
Time Frame
12-hour recording periods for each intervention
Title
Paired difference in time spent with peripheral oxygen saturations <80%
Description
Paired difference in total time spent with an oxygen saturation <80% between intervention periods. Peripheral oxygen saturation and heart rate will be monitored with an oximeter sensor placed around the infants' wrist or ankle and connected to the oximeter in 2 seconds averaging mode and maximum sensitivity.
Time Frame
12-hour recording periods for each intervention
Title
Paired difference in time spent with heart rate <80 bpm
Description
Paired difference in total time spent with a heart rate <80 beats per minute between intervention periods. Peripheral oxygen saturation and heart rate will be monitored with an oximeter sensor placed around the infants' wrist or ankle and connected to the oximeter in 2 seconds averaging mode and maximum sensitivity.
Time Frame
12-hour recording periods for each intervention
Title
Paired difference in mean respiratory rate (as counted by nurses and manually) documented according to clinical routine) and heart rate
Description
Paired difference in mean respiratory rate between intervention periods. Respiratory rate will be counted and documented by nurses every 4 to 8 hours according to clinical standard and documented in the patient data management system.
Time Frame
12-hour recording periods for each intervention
Title
Paired difference in the apnea score documented by nurses
Description
Paired difference in the apnea score (objective scoring system for the number and severity of apneas during a dedicated time frame) between intervention periods. Definition of the apnea score: Cumulative number of bradycardia <80 bpm and desaturations <80% during sleep and unimpaired wakefulness. Score 1 for event without need for intervention, score 2 for event requiring tactile stimulation, score 3 for event requiring increase of FiO2, score 8 for event requiring mask ventilation.
Time Frame
12-hour recording periods for each intervention
Title
Paired difference in desaturations requiring stimulation or increase in FiO2
Description
Paired difference in the total number of desaturations requiring manual stimulation or an increase in supplemental oxygen between intervention periods. Manual stimulation will be documented by nurses in the patient data management system.
Time Frame
12-hour recording periods for each intervention
Title
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)
Description
Paired difference in amount of gastric residuals (mL) between intervention periods. Before each feed, nurses routinely aspirate orogastric tubes to check for the liquid volume and document the amount in mL in the patient data management system.
Time Frame
12-hour recording periods for each intervention
Other Pre-specified Outcome Measures:
Title
Prespecified subgroup analyses of the primary outcome will be performed according to the type of aroma (vanilla or strawberry) that was administered.
Description
A prespecified subgroup analysis for the primary outcome will be performed between infants receiving vanilla and strawberry aroma.
Time Frame
12-hour recording periods for each intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
72 Hours
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janine Thomann, MD
Phone
0041432538774
Email
janine.thomann@usz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Christoph Rüegger, PD
Phone
0041432539810
Email
christoph.rueegger@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janine Thomann, MD
Organizational Affiliation
Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neonatology, Newborn Research, University Hospital and University of Zurich,
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janine Thomann, MD
Phone
+41432538774

12. IPD Sharing Statement

Plan to Share IPD
No

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

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