Respiratory Events Among Premature Infants | NCT00889070

Studies
Respiratory Events Among Premature Infants

NCT00889070

Sponsor

MedImmune LLC

Status

Completed

Last Update Posted

Aug 7, 2009Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Respiratory Syncytial Virus

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

Aug 2009

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 2008

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Apr 24, 2009

First Submission Date that Met QC Criteria

Apr 24, 2009

First Posted Date

Apr 28, 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

Aug 6, 2009

Last Update Posted Date

Aug 7, 2009Estimated

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

Assess the burden of disease associated with RSV infection with premature children in an outpatient setting.

Detailed Description

The primary objective of this prospective study is to assess the burden of disease associated with RSV infection, as measured/determined by rates of outpatient medically attended LRI, emergency room visits and hospitalization among preterm infants (32-≤36 wGA) during RSV season, and its medical/health consequences, as measured by wheezing events, the infant's first RSV season, up to May 2009.

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Stage 1 (Pilot Study) All infants enrolled in the pilot stage and completing baseline screening will be evaluated as the analyzable set.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The rate of RSV positivity and rate of outpatient and/or inpatient LRI events as well as the rate of outpatient and inpatient wheezing events.		Seasonal: 2008-09

Secondary Outcomes

Measure	Description	Time Frame
Evaluate characteristics of infants in RSV risk factor and rate and reason of attrition.		Seasonal: 2008-09

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent from parent/guardian to participate in study
Male or female preterm infants 32-≤36 wGA
Infant is ≤ 6month old at the time of enrollment
Parent/guardian has the ability and willingness to follow study protocol (during the first RSV season) as required by the protocol

Exclusion Criteria:

Receipt of any RSV prophylactic agent: palivizumab, IGIV, or motavizumab at any time prior to enrollment
Participation in trials of investigational RSV prophylaxis or RSV therapeutic agents
Presence of BPD or CHD (other than surgically treated PDA, ASD or VSD)
Condition that limits life span to 6 months or less from the date of enrollment

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

Male or female preterm infants 32-≤36 wGA

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hanaa Elhefni, MD, MS, MPH	MedImmune LLC	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Primary Care Medical Group, Inc.		San Diego	California	92120	United States
North Florida Pediatrics