Telephone Follow-up From an Intensive Care Nursery | NCT00604240

Studies
Telephone Follow-up From an Intensive Care Nursery

NCT00604240

Sponsor

Christiana Care Health Services

Status

Completed

Last Update Posted

May 10, 2017Actual

Enrollment

175Actual

Phase

Not provided

Conditions

Information Retention

Interventions

Not provided

Countries

United States

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

May 2017

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 2007

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Jan 17, 2008

First Submission Date that Met QC Criteria

Jan 29, 2008

First Posted Date

Jan 30, 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

May 9, 2017

Last Update Posted Date

May 10, 2017Actual

Name	Class
Thomas Jefferson University	OTHER

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 first few weeks after leaving the Neonatal Intensive Care Unit (NICU) can be a difficult transition time for caregivers of a previously hospitalized infant. To help ease this stressful period, doctors and nurses give caregivers a large amount of information prior to their infant leaving the NCIU. How much caregivers remember about medications, follow-up appointments, and general well-child care has not been studied. Caregivers who choose to participate will receive a phone call 2-7 days after discharge where they will be asked questions pertaining to the information that was discussed with them at the time of discharge. The purpose of the study is to determine how much information caregivers retain after leaving the NICU.

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

No data available

No data is available for this block.

Enrollment

175Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Parents / caregivers of any infant who has a length of stay of at least 1 week in the NICU at Christiana Hospital or Thomas Jefferson University Hospital.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amount of information that parents / caregivers are able to retain		Within one week after the infant is discharged from the NICU

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Parents/caregivers of infants who have spent one week or longer in the NICU at Christiana Hospital or Thomas Jefferson University Hospital.

Exclusion Criteria:

Parents / caregivers of infants who have spent less than one week in the NICU at Christiana Hospital or Thomas Jefferson University Hospital.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Parents/caregivers of infants who are hospitalized in the NICU

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Constance Andrejko, DO	Christiana Hospital and Thomas Jefferson University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Christiana Hospital		Newark	Delaware	19711	United States
Thomas Jefferson University Hospital