Pain Detection and Interception in Neonates

Pain Detection Clinical Trial

Official title:

Pain Detection and Interception in Neonates During Blood Sampling

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00447824
• Other study ID #: S-06471a
• Status: Recruiting
• Phase: N/A
• First received: March 13, 2007
• Last updated: March 13, 2007
• Start date: March 2007
• Est. completion date: November 2009

Study information

• Verified date: March 2007
• Source: Sorlandet Hospital HF
• Contact: Knut G Hernes, Dr
• Phone: +(47) 957 99999
• Email: drhernes[@]gmail.com
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

Description:

introducing the: Newborn Individualized Developmental Care and Assessment Program

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 31 Weeks to 36 Weeks

Eligibility

Inclusion Criteria:

• Born gestation age 31-36

Exclusion Criteria:

• Infection, respiratory distress

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain Detection
• Pain Intervention

Intervention

Procedure:
• Introduction of better conditions during blood sampling

Locations

Country	Name	City	State
Norway	Sorlandet Hospital SSHF	Kristiansand	Vest Agder

Sponsors (2)

Lead Sponsor	Collaborator
Sorlandet Hospital HF	Helse sor

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	value of Premature Infant Pain Profile
Primary	Heart rate
Primary	Saturation
Primary	Skin conductance changes