NCT00396838|Completed
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Sponsor study identifier
observational
300
1 country
1
Study Start
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2008
Actual (reported)Study Completion
April 2008
Actual (reported)Background: Heel lancing is a routine procedure for the diagnosis of phenylketonuria in infants. Despite the short- and long-term adverse effects of pain, there are no guidelines for the reduction of such pain. Previous studies evaluated different treatment modalities; however, in most of them, pain response was assessed by subjective measures. Aims of study: 1. To characterize the pain response of infants by using a computerized analysis of the ECG. 2. To compare six different methods of pain reduction during heel lancing in newborns. Methods: The time, geometric and frequency domains of the infants' ECG will be computed during heel lancing. 150 healthy full-term infants will be evaluated in six treatment groups: breastfeeding, bottle feeding, skin-to-skin contact, lying on a table without anything, lying with a pacifier and lying while getting a glucose solution. The differences in pain response to these six treatment modalities will be assessed and compared to the infants' length of cry, and scoring of the infants' behavioral response.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2008
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
November 7, 2006
Actual (reported)November 8, 2006
Actual (reported)April 2008
Actual (reported)April 2008
Actual (reported)Rambam MC
Haifa, Israel
Weissman A, Aranovitch M, Blazer S, Zimmer EZ. Heel-lancing in newborns: behavioral and spectral analysis assessment of pain control methods. Pediatrics. 2009 Nov;124(5):e921-6. doi: 10.1542/peds.2009-0598. Epub 2009 Oct 19.
Amir Weissman, MD
Rambam MC
First Submitted
November 7, 2006
First Posted
November 8, 2006
Study Start
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2008
Actual (reported)Changes in Heart Rate in Response to Heat Pressure and Neural Stimulation
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Study Completion
April 2008
Actual (reported)Last Updated
October 15, 2008
Record last verified: 2008-03
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