NCT00447824

Brief Summary

Hypothesis:

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2007

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

March 15, 2007

Status Verified

March 1, 2007

First QC Date

March 13, 2007

Last Update Submit

March 13, 2007

Conditions

Pain DetectionPain Intervention

Keywords

PainNeonatesNIDCAPVenousCapillary

Outcome Measures

Primary Outcomes (4)

  • value of Premature Infant Pain Profile

  • Heart rate

  • Saturation

  • Skin conductance changes

Interventions

Introduction of better conditions during blood samplingPROCEDURE

Eligibility Criteria

Age31 Weeks - 36 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Born gestation age 31-36

You may not qualify if:

  • Infection, respiratory distress

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sorlandet Hospital SSHF

Kristiansand, Vest Agder, 4600, Norway

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Knut G Hernes, Dr

    STUDY CHAIR

Central Study Contacts

Knut G Hernes, Dr

CONTACT

+(47) 957 99999drhernes@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 13, 2007

First Posted

March 15, 2007

Study Start

March 1, 2007

Study Completion

November 1, 2009

Last Updated

March 15, 2007

Record last verified: 2007-03

Locations

NO(1)