Respiratory Syncytial VirusNCT00889070
Respiratory Events Among Premature Infants
An observational study of Respiratory Syncytial Virus, run by MedImmune LLC at 5 sites in United States.
Trial summary
Assess the burden of disease associated with RSV infection with premature children in an outpatient setting. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Respiratory Syncytial Virus
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2008to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Male or female preterm infants 32-≤36 wGA
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Senders Pediatrics
Cleveland, Ohio, 44421
North Florida Pediatrics
Lake City, Florida, 32025
Children's Primary Care Medical Group, Inc.
San Diego, California, 92120
Suny Upstate Medical University
Syracuse, New York, 13120
Woburn Pediatric Associates
Woburn, Massachusetts, 18013
About this study
Official title: Respiratory Events Among Premature Infants (32-<36 w/GA) - Outcomes & Risk Tracking Study (The REPORT Study)
Assess the burden of disease associated with RSV infection with premature children in an outpatient setting.
Read the detailed 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.
- Conditions
- Respiratory Syncytial Virus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Stage 1 (Pilot Study) All infants enrolled in the pilot stage and completing baseline screening will be evaluated as the analyzable set. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Seasonal: 2008-09
Secondary outcomes (1)
Evaluate characteristics of infants in RSV risk factor and rate and reason of attrition.
Measured: Seasonal: 2008-09
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startNov 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hanaa Elhefni, MD, MS, MPH, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889070
- Sponsor's protocol ID
- MI-MA192
- Status last verified
- Aug 2009
- First submitted
- 24 Apr 2009
- Last updated
- 7 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Events Among Premature Infants (32-<36 w/GA) - Outcomes & Risk Tracking Study (The REPORT Study)
- ClinicalTrials.gov ID
- NCT00889070
- Acronym / sponsor ID
- MI-MA192
- Conditions
- Respiratory Syncytial Virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 28 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the burden of disease associated with RSV infection with premature children in an outpatient setting.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Stage 1 (Pilot Study) All infants enrolled in the pilot stage and completing baseline screening will be evaluated as the analyzable set. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Male or female preterm infants 32-≤36 wGA
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Evaluate characteristics of infants in RSV risk factor and rate and reason of attrition.
Time frame: Seasonal: 2008-09
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanaa Elhefni, MD, MS, MPH study director
MedImmune LLC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus, run by MedImmune LLC at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2009.