Association Between the Support of NICU Team and Subjecti... | NCT01006928

Studies
Association Between the Support of NICU Team and Subjective Health of Parents

NCT01006928

Sponsor

Hillel Yaffe Medical Center

Status

Completed

Last Update Posted

Jun 8, 2011Estimated

Enrollment

150Actual

Phase

Not provided

Conditions

Conditions Influencing Health Status

Interventions

Questionaire

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

Jun 2011

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

Dec 2009

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Nov 1, 2009

First Submission Date that Met QC Criteria

Nov 2, 2009

First Posted Date

Nov 3, 2009Estimated

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 5, 2011

Last Update Posted Date

Jun 8, 2011Estimated

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

Preterm birth is a traumatic event for parents. They cope with threatening and unfamiliar environment of hospital, losing the parental role, and frustration. The NICU team is the main support source for these parents. Support and providing information are most important for parents, as they can have some control, involvement and self confidence during the hospitalization, and also feel healthier. The hypothesis of this study is that better support to parents lead to better subjective health feeling by them.

The study will be held among mothers to infants in NICU who are at least 7 days old. The study will use a questionaire to assess the subjective health feeling and the estimation of the support from the team. Sample size is about 150 mothers.

Detailed Description

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

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mothers		Mother of infants in NICU	Other: Questionaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionaire	Other	Questionaire to mothers	Mothers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Good subjective health feeling of mother.		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mothers to preterm infants in NICU

Exclusion Criteria:

Mothers to Infants in NICU who are not preterm
Mothers to Infants in NICU who died during hospitalization
Mothers to Infants in NICU who were transferred to another hospital during hospitalization

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Mothers of infants in NICU

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erez Nadir, MD	Hillel Yaffe medical centet, Hadera, Israel	Principal Investigator

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18182470	Background	Arockiasamy V, Holsti L, Albersheim S. Fathers' experiences in the neonatal intensive care unit: a search for control. Pediatrics. 2008 Feb;121(2):e215-22. doi: 10.1542/peds.2007-1005. Epub 2008 Jan 8.
7567484	Background	Bloom KC. The development of attachment behaviors in pregnant adolescents. Nurs Res. 1995 Sep-Oct;44(5):284-9.