Measurements of Colloid Osmotic Pressure in Interstitial... | NCT01044940

Studies
Measurements of Colloid Osmotic Pressure in Interstitial Fluid and Plasma in Healthy and Sick Children

NCT01044940

Sponsor

Haukeland University Hospital

Status

Completed

Last Update Posted

Sep 10, 2015Estimated

Enrollment

17Actual

Phase

Not provided

Conditions

Colloid Osmotic Pressure

Interventions

Not provided

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

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2015Actual

First Submitted Date

Jan 7, 2010

First Submission Date that Met QC Criteria

Jan 7, 2010

First Posted Date

Jan 8, 2010Estimated

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

Sep 9, 2015

Last Update Posted Date

Sep 10, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to measure colloid osmotic pressure in interstitial fluid and plasma in healthy children under two years, in asphyxiated babies and in children undergoing heart surgery.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Birth asphyxia		Babies suffering from birth asphyxia
Blood transfusion		Babies who receives blood transfusion
Heart Surgery		Babies who need heart surgery

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Colloid osmotic pressure		6, 12, 24, 48, 72 hours post partum

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Newborn

Exclusion Criteria:

Syndromes

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Hour

Maximum Age

2 Years

Standard Ages

Child

Study Population

Asphyxiated babyes Children with heart defects who need surgery Newborn who need blood transfusion

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hans Joergen T Guthe, MD	Haukeland University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Haukeland University hospital		Bergen	Bergen	5000	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29471782	Derived	Guthe HJT, Nedrebo T, Damas JK, Wiig H, Berg A. Transcapillary fluid flux and inflammatory response during neonatal therapeutic hypothermia: an open, longitudinal, observational study. BMC Pediatr. 2018 Feb 23;18(1):82. doi: 10.1186/s12887-018-1020-3.