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Pain Detection and Interception in Neonates
This study is currently recruiting participants.
Verified by Sorlandet Hospital HF, March 2007
Sponsors and Collaborators: Sorlandet Hospital HF
Helse sor
Information provided by: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT00447824
  Purpose

Hypothesis:

  1. May the introduction of NIDCAP during blood sample reduced pain in neonates during blood sample
  2. Compare the effect of venous and capillary blood sample method

Condition Intervention
Pain Detection
Pain Intervention
 Procedure: Introduction of better conditions during blood sampling

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Pain Detection and Interception in Neonates During Blood Sampling

Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:
  • value of Premature Infant Pain Profile
  • Heart rate
  • Saturation
  • Skin conductance changes

Estimated Enrollment: 160
Study Start Date: March 2007
Estimated Study Completion Date: November 2009
Detailed Description:

introducing the: Newborn Individualized Developmental Care and Assessment Program

  Eligibility

Ages Eligible for Study:   31 Weeks to 36 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Born gestation age 31-36

Exclusion Criteria:

  • Infection, respiratory distress
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447824

Contacts
Contact: Knut G Hernes, Dr +(47) 957 99999 drhernes@gmail.com

Locations
Norway, Vest Agder
Sorlandet Hospital SSHF Recruiting
Kristiansand, Vest Agder, Norway, 4600
Sub-Investigator: Liv Normann            
Sub-Investigator: Randi S Dahl            
Sponsors and Collaborators
Sorlandet Hospital HF
Helse sor
Investigators
Study Chair: Knut G Hernes, Dr Unaffiliated
  More Information

Study ID Numbers: S-06471a
Study First Received: March 13, 2007
Last Updated: March 13, 2007
ClinicalTrials.gov Identifier: NCT00447824  
Health Authority: Norway: The National Committees for Research Ethics in Norway

Keywords provided by Sorlandet Hospital HF:
Pain
Neonates
NIDCAP
Venous
Capillary

Study placed in the following topic categories:
Pain

ClinicalTrials.gov processed this record on January 16, 2009



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