Thermal Analgesia in Newborns

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2013 by University of Chicago.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
University of Chicago Identifier:
First received: August 20, 2008
Last updated: October 8, 2013
Last verified: October 2013
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.

Condition Intervention
Other: sucrose
Other: warmth

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Thermal Analgesia in Newborns

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Decreased behavioral and physiologic indicators of pain [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2008
Estimated Study Completion Date: July 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Sweet Taste
Other: sucrose
sweet taste
Active Comparator: 2
Other: warmth


Ages Eligible for Study:   up to 2 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy infants

Exclusion Criteria:

  • unhealthy infants
  Contacts and Locations
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Please refer to this study by its identifier: NCT00740298

United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Principal Investigator: Lawrence A Gray, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago Identifier: NCT00740298     History of Changes
Other Study ID Numbers: 15480A, 5K23HD049452
Study First Received: August 20, 2008
Last Updated: October 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
vaccinations processed this record on November 25, 2015