Status:
COMPLETED
Skin Blood Flow Changes Using Laser Doppler Imager for Assessment of Pain and Analgesia in Newborn Infants
Lead Sponsor:
Children's Hospital of Michigan
Conditions:
Procedural Pain
Eligibility:
All Genders
1-7 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess whether an instrument, the Laser Doppler Imager, is able to measure the effect of pain related changes in skin blood flow in newborn infants. The study will also...
Detailed Description
During the last 25 years evidence that newborns can experience pain has been increasing. Painful procedures (injections, heel lances, and circumcisions) are part of normal routine newborn care. Studie...
Eligibility Criteria
Inclusion
- Informed consent from parent or legal guardian.
- Term, newborn infant, between 1 and 7 days of age.
- Appropriate for gestational age (weight 5th through 95th percentile).
Exclusion
- Small or large for gestational age (weight\<5th or \>95th percentile).
- Physical or biochemical abnormalities.
- History of maternal drug dependence.
- Apgar score \<7 at 5 minutes.
- Current use of analgesics.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00694174
Start Date
September 1 2005
End Date
September 1 2007
Last Update
June 10 2008
Active Locations (1)
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1
Hutzel Women's University Hospital, The Detroit Medical Center
Detroit, Michigan, United States, 48201