"Iatrogenesis Imperfecta"- Extent and Characteristic in N... | NCT00264563

Studies
"Iatrogenesis Imperfecta"- Extent and Characteristic in NICU in Israel.

NCT00264563

Sponsor

Bnai Zion Medical Center

Status

Completed

Last Update Posted

Jun 17, 2011Estimated

Enrollment

750Estimated

Phase

Not provided

Conditions

Iatrogenesis in NICU

Interventions

Increasing the level of awareness to Iatrogenesis
Increasing awareness .

Countries

Israel

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

Aug 2005

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

Nov 2005

Primary Completion Date

Not provided

Completion Date

Apr 2006

First Submitted Date

Dec 12, 2005

First Submission Date that Met QC Criteria

Dec 12, 2005

First Posted Date

Dec 13, 2005Estimated

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

Jun 16, 2011

Last Update Posted Date

Jun 17, 2011Estimated

Description Module

Brief Summary

Iatrogenesis is inevitable in the NICUs.

Detailed Description

In the first 3 months of the study we will document Iatrogenic events in 3 NICUs in Israel without informing the medical and nursing staff. In the second 3 months of the study we will try to draw the attention of the medical and nursing staff that we are documenting iatogenesis, and we will assess wether this intervention will decrease the events of Iatrogenesis.

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

No data available

No data is available for this block.

Enrollment

750Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Behavioral		The intervention is basically by letting the care givers to be aware that there is active recording of iatrogenesis	Behavioral: Increasing the level of awareness to Iatrogenesis Behavioral: Increasing awareness .

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Increasing the level of awareness to Iatrogenesis	Behavioral	Increasing the level of awareness to Iatrogenesis	Behavioral

Eligibility Module

Eligibility Criteria

Inclusion Criteria:All infants in NICU -

Exclusion Criteria:None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

6 Months

Standard Ages

Child

Study Population

Ifants admitted to NICU during the study period

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amir Kugelman	Senior Neonatologist	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bnai Zion Medical Center		Haifa			Israel
Bnai Zion Medical Center, Rambam Medical Center, Barzilay Medical Center