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Completed

NCT Number: NCT00622817

The Influence of Inhaled Adrenalin Versus Decongestant as a Local Nasal Treatment in Bronchiolitis

This was a randomized, double blinded, controlled trial. The aim of the study was to compare xylometazoline HCL nasal drops to inhalation of epinephrine as a treatment for bronchiolitis.

The study hypothesis is:xylometazoline HCL nasal drops treatment is good as epinephrine inhalation for treatment of bronchiolitis.

Signed informed consent was obtained from a parent of each child. And the human ethics committee of our hospital approved the study according to the principles of the Declaration of Helsinki.(Approved - 2002)

Patients:

65 infants who were admitted to Pediatric A- a general pediatric ward, in Schneider Children's Medical Center because of bronchiolitis during winter in two consecutive years 2004-2005.

The inclusion criteria were: Full term previously healthy Infants, ages 1-12 months, after informed consent was signed with clinical presentation of mild to moderate bronchiolitis according to a clinical score .Exclusion criteria were as follows: prematurity, congenital lung or cardiac disease, infants who had past hospitalization due to respiratory illness and severe bronchiolitis (score>7 with a range scale 0-10).

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Key information

Conditions

Bronchiolitis Bronchial Diseases Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

All eligible patients were randomly assigned to one of two groups: Group 1 (control) received inhalation of epinephrine 1mg, in 2cc of 0.9% saline solution four times a day, and nasal drops of 0.9% saline for each nostril every twelve hours. Group 2 - the study group received four inhalation of 0.9% saline four times a day and one nasal drop of xylometazoline HCL to each nostril twice a day. This treatment continued until the patient was ready for discharge.

Patients were examined and evaluated at the study entry and were re-evaluated every 10-12 hours. Length of hospital stay,time to improve Oxygen saturation, time to the need of IV fluid and clinical score between the two groups of treatment were compared.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Full term previously healthy Infants
  • Ages 1-12 months
  • After informed consent was signed with clinical presentation of mild to moderate bronchiolitis

Exclusion criteria

  • Prematurity, congenital lung or cardiac disease
  • Infants who had past hospitalization due to respiratory illness and severe bronchiolitis (score >7 with a range scale 0-10)

Treatment and study plan

xylometazoline HCL 0.05%

Drug

Receive four inhalation of 0.9% saline four times a day and one nasal drop of xylometazoline HCL 0.05% to each nostril twice a day.

Other names: xylometazoline HCL = Otrivin nasal drops

Epinephrine 1mg

Drug

Patients are treated with inhalation of epinephrine 1mg and nasal drops of 0.9% saline for each nostril every twelve hours.

Primary outcomes

  1. Length of hospital stay

    Time frame: Two years

Secondary outcomes

  1. Time to improve oxygen saturation, comparison of clinical scores , Needs of IV fluids

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Schneider Children's Medical Center, Israel

Other

Registry information

Official study title

Double Blinded Controled Study:Treatment With Adrenaline Inhalation Versus Nasal Decongestant Drops for Bronchiolitis

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Feb 25, 2008
Registry last updated
Feb 26, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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