Respiratory Events Among Premature Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Respiratory Syncytial Virus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

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

No interventions assigned to this group

Eligibility Criteria

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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

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No