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OpenTrials
Completed

NCT Number: NCT00889070

Respiratory Events Among Premature Infants

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

Completed

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Key information

Conditions

Respiratory Syncytial Virus

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Primary Care Medical Group, Inc., San Diego, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

    Time frame: Seasonal: 2008-09

Secondary outcomes

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

    Time frame: Seasonal: 2008-09

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

Respiratory Events Among Premature Infants (32-<36 w/GA) - Outcomes & Risk Tracking Study (The REPORT Study)

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 28, 2009
Registry last updated
Aug 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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