Apnea, Bronchiolitis, Pneumonia, Respiratory Infections
Conditions
Keywords
Acute Lower Respiratory Infection, Retractions, Bronchiolitis or pneumonia, Wheezing, Rales, Crackles
Brief summary
The primary objective of this study is to describe the incidence of RSV-associated LRI among infants \<1 year of age presenting to the ED during selected shoulder months.
Detailed description
* The primary objective of this study is to describe the incidence of RSV-associated LRI or apnea (% RSV positive) among infants \<1 year of age presenting to the ED during selected shoulder months. The total number of events will also be described. * To characterize the clinical outcomes and demographic data of infants presenting to the ED with RSV-associated LRI or apnea * To characterize the social burden (in the form of number of days lost from work by parent/ guardian) for these infants through 14 days after the index ED visit and through hospital discharge will also be described. * Based on a sample of cases collected in a cohort of patients enrolled at or near the peak of RSV disease during the traditional season, a comparison of the rate of RSV between shoulder and peak periods will be described. * To describe the overall rates of RSV-associated LRI or apnea based on the general ED statistics collected during the entire study period.
Interventions
OTHEREmergency Dept. Subjects with LRI or Apnea
No intervention; Epidemiological Study
Sponsors
MedImmune LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 12 Months
Healthy volunteers
No
Inclusion criteria
* Written informed consent from parent/guardian to participate in this study * Male and female infants \<1 year of age (child must be entered before his/her 1st birthday) * Physician diagnosis of either a) acute LRI or b) apnea below: A) Acute LRI, defined as: 1. Medical diagnosis of bronchiolitis or pneumonia, or 2. In the absence of either of these diagnoses, LRI will be determined by the investigator after review of the medical record and must include at least one of the following: * Retractions * Wheezing * Rales or crackles * The presence of a new infiltrate, if a chest X-ray is available, which must be diagnosed by the ED physician or radiologist B) Apnea, defined as either: 1. Cessation of breathing for \>20 seconds by history or observation, or 2. Cessation of breathing for any length of time if accompanied by cyanosis or pallor, bradycardia as detected by a monitor, or 3. ED primary diagnosis of apnea * Parent/guardian has the ability and willingness to be available for a follow-up interview by telephone
Exclusion criteria
* Use of palivizumab or RSV-IGIV at any time prior to enrollment * Participation in trials of investigational RSV prophylaxis or therapeutic agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measuring the incidence of RSV-associated, LRI or apnea among infants <1 yr. old presenting the Emergency Dept. during shoulder months. | July 2008 |
Secondary
| Measure | Time frame |
|---|---|
| Clinical outcome of infants at Emergency Dept. with RSV-associated LRI or apnea.(hospital admission, 23 hr.-observations,no. of outpatient and/or urgent care visits,ICU,mechanical ventilation,supplemental oxygen use, meds,admission rate) | July 2008 |
| Societal burden(no. of days lost from work by parent/guardian) for infants through 14 days after index ED visit and through hospital discharge. | July 2008 |
| Comparison of rates of RSV-associated LRI or apnea during the peak periods and between shoulder and peak periods. | July 2008 |
| Overall rates of RSV-associated LRI or apnea based on general ED statistics collected during the entire study period, including outside recruitment periods. | July 2008 |
Countries
United States
Outcome results
None listed