Respiratory Events Among Premature Infants

MedImmune

Status: Completed

Conditions: Respiratory Syncytial Virus

Study type: Observational

Funder types: Industry

Identifiers

NCT00889070

MI-MA192

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

1

Description:

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