Interface Acceptance During Delivery of Aerosol Medicine to an Infant or ChildNCT02082379
In-Vivo Evaluation of Nebulized Aerosols Delivered Via Nasal Route
A study testing inhaled normal saline using different interfaces. in people with Interface Acceptance During Delivery of Aerosol Medicine to an Infant or Child, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
We hypothesize that infant and children will show different levels of acceptance of different interfaces while they receive inhaled therapy. We also hypothesize that children will exhibit different amounts of time with the aerosol well aligned with the nostrils during transnasal aerosol delivery. Read more about this study
- Who is it for?
- Ages 1 week to 8 monthsHealthy volunteers can take part
- Conditions the study is for
- Interface Acceptance During Delivery of Aerosol Medicine to an Infant or Child
- What is being tested?
- inhaled normal saline using different interfaces.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 8 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Born at term
- Healthy
- Pacifier user
- Newborn 1-6 week old
- Infants 6-8 month old
Who cannot join
- Chronic respiratory disease
- Cardiac disease
- Prematurity
- Neurological disease
- Allergy to Normal Saline
- Allergy to any components of the interfaces
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
About this study
We hypothesize that infant and children will show different levels of acceptance of different interfaces while they receive inhaled therapy.
We also hypothesize that children will exhibit different amounts of time with the aerosol well aligned with the nostrils during transnasal aerosol delivery.
Read the detailed description
Aerosol medicine is widely used in treating pulmonary diseases in children. Delivering drugs via aerosol faces several challenges; some are related to the drug and the delivery methods and others to the patient behavior. The latter are crucial and can significantly affect the lung deposition of the drug. Infants are known to be obligate nose breathers making the transnasal route the natural approach for drug delivery in this age group. Different interfaces are already available in the market and are specifically designed to be used in children to improve the child acceptability of the interface and by the result to improve drug deposition. Due to limitations in the use of radiolabeled aerosols and pharmacokinetics/pharmacodynamics studies in infants and children, in-vitro models were developed. These models still lack biological variability which leads to overestimating lung deposition. So, real life correction factors are needed to improve current in-vitro modeling. Previous unpublished data from our laboratory showed that alignment of the aerosol stream with the nostrils is very important for pulmonary deposition.
Our objectives are to provide real life data of acceptance of different interfaces by infants and children and to provide a real life correction factor to improve current in-vitro modeling.
- Being tested
- inhaled normal saline using different interfaces.
- Keywords
- Interface, aerosol, child, acceptance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled normal saline using different interfaces.Behavioural
A Hudson nebulizer will be loaded with 3 mls of normal saline and operated at 7 L/min of wall air for 3 minutes with each scenario with a 5-minute interval between interfaces. The infants will be videotape while they receive inhaled aerosol, and sound will be captured. The camera will be positioned so the face of the parent holding the child will not be visible.
| Study group | Role | What they receive |
|---|---|---|
| Term newborns 1-6 week old | Active comparator | A Hudson nebulizer will be loaded with 3 mls of normal saline and operated at 7 L/min of wall air for 3 minutes with each scenario with a 5-minute interval between interfaces. The interfaces that will be used are: tight mask, the angled PediNeb, the B\&B adapter, mask placed at 2 cm from the face, the PediNeb T-piece, and a capped corrugated tubing placed 2 cm away from the face. Receives: Behavioral: inhaled normal saline using different interfaces. |
| Infants 6-8 month old | Active comparator | A Hudson nebulizer will be loaded with 3 mls of normal saline and operated at 7 L/min of wall air for 3 minutes with each scenario with a 5-minute interval between interfaces. The interfaces that will be used are: tight mask, the angled PediNeb, the B\&B adapter, mask placed at 2 cm from the face, the PediNeb T-piece, and a capped corrugated tubing placed 2 cm away from the face. Receives: Behavioral: inhaled normal saline using different interfaces. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance of different interfaces while they receive inhaled therapy
The recordings will be analyzed by the 2 investigators for acceptance of the patient of the interface (likert scale 1 to 5: 5= Complete acceptance, 4= Accepting most of the time, 3= Accepting/rejecting half of the time, 2= Rejecting most of the time, 1= Complete rejection). The data will be expressed as average of value assigned by each of the 2 researchers. Analysis of variance for repeated measures followed by Tukey test will be used to compare the 2 endpoints. A p value < 0.05 will be considered statistically significant
Measured: within the 3 minutes of nebulization for 3 consecutive times with 5 minutes rest in between the each nebulization
Secondary outcomes (1)
Amounts of time with the aerosol well aligned with the nostrils during transnasal aerosol delivery
The recordings will be analyzed by the 2 investigators for percentage of time spent with aerosol aligned with the patient nostrils when using different interfaces
Measured: during the 3 minutes of nebulization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interface Acceptance During Delivery of Aerosol Medicine to an Infant or ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katia El Taoum, MD, Principal investigator, UAMSAriel Berlinski, MD, Principal investigator, UAMS/ACHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082379
- Sponsor's protocol ID
- 202438
- Status last verified
- Jan 2016
- First submitted
- 11 Feb 2014
- Last updated
- 7 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Vivo Evaluation of Nebulized Aerosols Delivered Via Nasal Route
- ClinicalTrials.gov ID
- NCT02082379
- Acronym / sponsor ID
- 202438
- Keywords
- Interface, aerosol, child, acceptance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 10 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesize that infant and children will show different levels of acceptance of different interfaces while they receive inhaled therapy.
We also hypothesize that children will exhibit different amounts of time with the aerosol well aligned with the nostrils during transnasal aerosol delivery.
Detailed description
Aerosol medicine is widely used in treating pulmonary diseases in children. Delivering drugs via aerosol faces several challenges; some are related to the drug and the delivery methods and others to the patient behavior. The latter are crucial and can significantly affect the lung deposition of the drug. Infants are known to be obligate nose breathers making the transnasal route the natural approach for drug delivery in this age group. Different interfaces are already available in the market and are specifically designed to be used in children to improve the child acceptability of the interface and by the result to improve drug deposition. Due to limitations in the use of radiolabeled aerosols and pharmacokinetics/pharmacodynamics studies in infants and children, in-vitro models were developed. These models still lack biological variability which leads to overestimating lung deposition. So, real life correction factors are needed to improve current in-vitro modeling. Previous unpublished data from our laboratory showed that alignment of the aerosol stream with the nostrils is very important for pulmonary deposition.
Our objectives are to provide real life data of acceptance of different interfaces by infants and children and to provide a real life correction factor to improve current in-vitro modeling.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Term newborns 1-6 week old | Active comparator | Behavioral: inhaled normal saline using different interfaces.A Hudson nebulizer will be loaded with 3 mls of normal saline and operated at 7 L/min of wall air for 3 minutes with each scenario with a 5-minute interval between interfaces. The interfaces that will be used are: tight mask, the angled PediNeb, the B\&B adapter, mask placed at 2 cm from the face, the PediNeb T-piece, and a capped corrugated tubing placed 2 cm away from the face. |
| Infants 6-8 month old | Active comparator | Behavioral: inhaled normal saline using different interfaces.A Hudson nebulizer will be loaded with 3 mls of normal saline and operated at 7 L/min of wall air for 3 minutes with each scenario with a 5-minute interval between interfaces. The interfaces that will be used are: tight mask, the angled PediNeb, the B\&B adapter, mask placed at 2 cm from the face, the PediNeb T-piece, and a capped corrugated tubing placed 2 cm away from the face. |
Who may qualify
- Ages
- 1 week to 8 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Born at term
- Healthy
- Pacifier user
- Newborn 1-6 week old
- Infants 6-8 month old
Key exclusion criteria (6 listed)
- Chronic respiratory disease
- Cardiac disease
- Prematurity
- Neurological disease
- Allergy to Normal Saline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inhaled normal saline using different interfaces.A Hudson nebulizer will be loaded with 3 mls of normal saline and operated at 7 L/min of wall air for 3 minutes with each scenario with a 5-minute interval between interfaces. The infants will be videotape while they receive inhaled aerosol, and sound will be captured. The camera will be positioned so the face of the parent holding the child will not be visible. | Behavioural | Infants 6-8 month old, Term newborns 1-6 week old |
Primary outcome
Acceptance of different interfaces while they receive inhaled therapy
Time frame: within the 3 minutes of nebulization for 3 consecutive times with 5 minutes rest in between the each nebulization
The recordings will be analyzed by the 2 investigators for acceptance of the patient of the interface (likert scale 1 to 5: 5= Complete acceptance, 4= Accepting most of the time, 3= Accepting/rejecting half of the time, 2= Rejecting most of the time, 1= Complete rejection). The data will be expressed as average of value assigned by each of the 2 researchers. Analysis of variance for repeated measures followed by Tukey test will be used to compare the 2 endpoints. A p value < 0.05 will be considered statistically significant
1 secondary outcome
Amounts of time with the aerosol well aligned with the nostrils during transnasal aerosol delivery
Time frame: during the 3 minutes of nebulization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katia El Taoum, MD principal investigator
UAMS
Ariel Berlinski, MD principal investigator
UAMS/ACHRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inhaled normal saline using different interfaces. in people with Interface Acceptance During Delivery of Aerosol Medicine to an Infant or Child, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance of different interfaces while they receive inhaled therapy (time frame: within the 3 minutes of nebulization for 3 consecutive times with 5 minutes rest in between the each nebulization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016.