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Pain Detection and Interception in Neonates

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2007 by Sorlandet Hospital HF.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00447824
First Posted: March 15, 2007
Last Update Posted: March 15, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Helse sor
Information provided by:
Sorlandet Hospital HF
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
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

Information from the National Library of Medicine

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Ages Eligible for Study:   31 Weeks to 36 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Born gestation age 31-36

Exclusion Criteria:

  • Infection, respiratory distress
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00447824


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

Locations
Norway
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
  More Information

ClinicalTrials.gov Identifier: NCT00447824     History of Changes
Other Study ID Numbers: S-06471a
First Submitted: March 13, 2007
First Posted: March 15, 2007
Last Update Posted: March 15, 2007
Last Verified: March 2007

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