Pain Detection and Interception in Neonates

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Sorlandet Hospital HF.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Helse sor
Information provided by:
Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT00447824
First received: March 13, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

No publications provided

ClinicalTrials.gov Identifier: NCT00447824     History of Changes
Other Study ID Numbers: S-06471a
Study First Received: March 13, 2007
Last Updated: March 13, 2007
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

ClinicalTrials.gov processed this record on September 14, 2014