In-Vivo Evaluation of Nebulized Aerosols Delivered Via Nasal Route
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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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 Previous unpublished data from our laboratory showed that alignment of the aerosol stream with the nostrils is very important for pulmonary deposition.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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Arkansas
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Little Rock, Arkansas, Vereinigte Staaten, 72202
- Arkansas Children's Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Born at term
- Healthy
- Pacifier user
- Newborn 1-6 week old
- Infants 6-8 month old
Exclusion Criteria:
- Chronic respiratory disease
- Cardiac disease
- Prematurity
- Neurological disease
- Allergy to Normal Saline
- Allergy to any components of the interfaces
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: Term newborns 1-6 week old
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.
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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.
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Aktiver Komparator: Infants 6-8 month old
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.
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Acceptance of different interfaces while they receive inhaled therapy
Zeitfenster: within the 3 minutes of nebulization for 3 consecutive times with 5 minutes rest in between the each nebulization
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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
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within the 3 minutes of nebulization for 3 consecutive times with 5 minutes rest in between the each nebulization
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Amounts of time with the aerosol well aligned with the nostrils during transnasal aerosol delivery
Zeitfenster: during the 3 minutes of nebulization
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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
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during the 3 minutes of nebulization
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Katia El Taoum, MD, UAMS
- Hauptermittler: Ariel Berlinski, MD, UAMS/ACHRI
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 202438
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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