NCT01575821|Completed
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Sponsor study identifier
interventional
300
1 country
1
Study Start
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2012
Actual (reported)Study Completion
April 2012
Actual (reported)Cough is a common symptom in pediatric practice. It can be particularly troubling to children and their parents.It often results in discomfort to the child and loss of sleep to both the child and the parent. The objective of this trial was to compare the effects on nocturnal cough and the sleep difficulty associated with URIs of a single nocturnal dose of three different honey products compared to placebo
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
April 2012
Actual (reported)April 2012
Actual (reported)April 8, 2012
Actual (reported)April 12, 2012
Actual (reported)The principal outcome measure of interest was the change in the frequency of cough between the 2 nights (before treatment and tthe night with treatment).
Pre intervention study questionnaire: The parents were asked to complete a five item questionnaire regarding parental subjective assessments of the child's cough and sleep difficulty on the previous night.Survey responses were graded on a seven point scale ranging from extremely (6 points) to not at all (0 points). On the day following the treatment,the parent completed the same questionnaire that had been answered before the intervention, this time regarding the previous evening when the child had received the treatment.
changes between two nights ( the night before treatment and the night with treatment)
changes in the cough severity, the bothersome nature of the cough, the effect of the cough on sleep for both the child and parents between the two nights
changes between two nights ( the night before treatment and the night with treatment)
75 children
75 children allocated
75 children allocated
Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.
Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.
6 General Pediatric Community Clinics
Petah Tikva, 56000, Israel
Paul IM, Beiler J, McMonagle A, Shaffer ML, Duda L, Berlin CM Jr. Effect of honey, dextromethorphan, and no treatment on nocturnal cough and sleep quality for coughing children and their parents. Arch Pediatr Adolesc Med. 2007 Dec;161(12):1140-6. doi: 10.1001/archpedi.161.12.1140.
Cohen HA, Rozen J, Kristal H, Laks Y, Berkovitch M, Uziel Y, Kozer E, Pomeranz A, Efrat H. Effect of honey on nocturnal cough and sleep quality: a double-blind, randomized, placebo-controlled study. Pediatrics. 2012 Sep;130(3):465-71. doi: 10.1542/peds.2011-3075. Epub 2012 Aug 6.
Cohen AV Herman
Israel Clalit Health Services
300 participants (actual enrollment reported by the registry).
First Submitted
April 8, 2012
First Posted
April 12, 2012
Study Start
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
Efficacy and Safety of the Device Siesta-SystemTM for Inducing Objective Sleep and re Rest
75 children allocated
Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.
Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.
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Primary Completion
April 2012
Actual (reported)Study Completion
April 2012
Actual (reported)Last Updated
April 12, 2012
Record last verified: 2012-04
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Source: ClinicalTrials.gov.
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