- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00740298
Thermal Analgesia in Newborns
April 24, 2023 updated by: University of Chicago
Newborns routinely experience pain associated with invasive procedures such as blood sampling, immunization, vitamin K injection, or circumcision.
Prevention of pain is both an ethical expectation and a professional imperative, as untreated pain has deleterious consequences including altered pain sensitivity in later childhood and may be related to the permanent neuroanatomical and behavioral abnormalities as found in animal models.
Moreover, pain is a source of concern and distress for new parents.
Yet, pain reducing therapies are often underused for the numerous minor procedures that are a part of routine medical and nursing care for neonates.
Growing scientific and clinical literature provides evidence for the effectiveness of natural, non-pharmacological techniques in both animal and human newborns.
This study compares the pain reliving effects of sweet taste to the combination of sweet taste and warmth.
Study Overview
Study Type
Interventional
Enrollment (Actual)
178
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- The University of Chicago
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 2 days (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- healthy infants
Exclusion Criteria:
- unhealthy infants
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Sweet Taste
|
sweet taste
|
Active Comparator: 2
warmth
|
warmth
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Decreased behavioral and physiologic indicators of pain
Time Frame: 5 minutes
|
5 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lawrence A Gray, MD, University of Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2008
Primary Completion (Actual)
April 26, 2018
Study Completion (Actual)
April 26, 2018
Study Registration Dates
First Submitted
August 20, 2008
First Submitted That Met QC Criteria
August 21, 2008
First Posted (Estimate)
August 22, 2008
Study Record Updates
Last Update Posted (Actual)
April 26, 2023
Last Update Submitted That Met QC Criteria
April 24, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 15480A
- 5K23HD049452 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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