- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00447824
Pain Detection and Interception in Neonates
March 13, 2007 updated by: Sorlandet Hospital HF
Pain Detection and Interception in Neonates During Blood Sampling
Hypothesis:
- May the introduction of NIDCAP during blood sample reduced pain in neonates during blood sample
- Compare the effect of venous and capillary blood sample method
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
introducing the: Newborn Individualized Developmental Care and Assessment Program
Study Type
Interventional
Enrollment
160
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 Contact
- Name: Knut G Hernes, Dr
- Phone Number: +(47) 957 99999
- Email: drhernes@gmail.com
Study Locations
-
-
Vest Agder
-
Kristiansand, Vest Agder, Norway, 4600
- Recruiting
- Sorlandet Hospital SSHF
-
Sub-Investigator:
- Liv Normann
-
Sub-Investigator:
- Randi S Dahl
-
-
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
7 months to 8 months (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Born gestation age 31-36
Exclusion Criteria:
- Infection, respiratory distress
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Heart rate
|
value of Premature Infant Pain Profile
|
Saturation
|
Skin conductance changes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
March 1, 2007
Study Completion
November 1, 2009
Study Registration Dates
First Submitted
March 13, 2007
First Submitted That Met QC Criteria
March 13, 2007
First Posted (Estimate)
March 15, 2007
Study Record Updates
Last Update Posted (Estimate)
March 15, 2007
Last Update Submitted That Met QC Criteria
March 13, 2007
Last Verified
March 1, 2007
More Information
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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