Organizing the Information Given to Parents of NICU Infan... | NCT00699127

Studies
Organizing the Information Given to Parents of NICU Infants in Order to Reduce Their Anxiety

NCT00699127

Sponsor

Hillel Yaffe Medical Center

Status

Withdrawn

Last Update Posted

Jul 4, 2008Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Anxiety

Interventions

Lecture

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

Jul 2008

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

After a discussion, we decided to withdraw the study.

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Jul 2008Estimated

Completion Date

Jul 2008Estimated

First Submitted Date

Jun 14, 2008

First Submission Date that Met QC Criteria

Jun 16, 2008

First Posted Date

Jun 17, 2008Estimated

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

Jul 3, 2008

Last Update Posted Date

Jul 4, 2008Estimated

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

Being a parent to a premature infant in NICU is an anxious state. Parents ask a lot of questions, and look for information all the time. Organizing the information given to parents could reduce their anxiety. The parents will be divided into two groups: one group will get organized information, by a lecture at the first week of their infant's life, and the other group will not. Of course, questions will be answered all the time. The parents will answer a questionnaire on the first week of the infant's life, and on the last week, just before releasing the infant home.

Detailed Description

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	The group that will have lecture of information regarding infants in NICU.	Behavioral: Lecture
2	No Intervention	The group that will not have lecture of information regarding NICU hospitalization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lecture	Behavioral	Lecture of information regarding prematurity, NICU hospitalization, etc.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference between questionnaires at the first week and the last week to hospitalization.		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Parents to premature infants, after releasing the mother

Exclusion Criteria:

Term infants
Hospitalized mother

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

4 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erez Nadir, MD	Hillel Yaffe medical center, Hadera, Israel	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe medical center		Hadera	Hadera	38100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D001008	Anxiety Disorders
D047928	Premature Birth

Ancestor Terms

ID	Term
D001523	Mental Disorders
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided