NCT00889070

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2008

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2009

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

August 7, 2009

Status Verified

August 1, 2009

Enrollment Period

6 months

First QC Date

April 24, 2009

Last Update Submit

August 6, 2009

Conditions

Respiratory Syncytial Virus

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Evaluate characteristics of infants in RSV risk factor and rate and reason of attrition.

    Seasonal: 2008-09

Study Arms (1)

1

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

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Male or female preterm infants 32-≤36 wGA

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Children's Primary Care Medical Group, Inc.

San Diego, California, 92120, United States

Location

North Florida Pediatrics

Lake City, Florida, 32025, United States

Location

Woburn Pediatric Associates

Woburn, Massachusetts, 18013, United States

Location

Suny Upstate Medical University

Syracuse, New York, 13120, United States

Location

Senders Pediatrics

Cleveland, Ohio, 44421, United States

Location

Study Officials

  • Hanaa Elhefni, MD, MS, MPH

    MedImmune LLC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 24, 2009

First Posted

April 28, 2009

Study Start

November 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

August 7, 2009

Record last verified: 2009-08

Locations

US(5)