Pain Detection and Interception in Neonates | NCT00447824

Studies
Pain Detection and Interception in Neonates

NCT00447824

Sponsor

Sorlandet Hospital HF

Status

Unknown status

Last Update Posted

Mar 15, 2007Estimated

Enrollment

160

Phase

Not Applicable

Conditions

Pain Detection
Pain Intervention

Interventions

Introduction of better conditions during blood sampling

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Not provided

Completion Date

Nov 2009

First Submitted Date

Mar 13, 2007

First Submission Date that Met QC Criteria

Mar 13, 2007

First Posted Date

Mar 15, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2007

Last Update Posted Date

Mar 15, 2007Estimated

Name	Class
Helse sor	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

introducing the: Newborn Individualized Developmental Care and Assessment Program

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160

Name	Type	Description	Arm Group Labels	Other Names
Introduction of better conditions during blood sampling	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
value of Premature Infant Pain Profile
Heart rate
Saturation
Skin conductance changes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Born gestation age 31-36

Exclusion Criteria:

Infection, respiratory distress

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

31 Weeks

Maximum Age

36 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Knut G Hernes, Dr	Contact	+(47) 957 99999		drhernes@gmail.com

Overall Officials

Name	Affiliation	Role
Knut G Hernes, Dr		Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sorlandet Hospital SSHF	Recruiting	Kristiansand	Vest Agder	4600	Norway

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided