Respiratory Syncytial Virus InfectionsNCT00384462
Study to Evaluate the Incidence of Hospitalizations and Respiratory Tract Infections in Premature Infants
An observational study of Respiratory Syncytial Virus Infections, run by MedImmune LLC at 59 sites in United States.
Trial summary
The purpose of this study is to describe respiratory syncytial virus (RSV) hospitalization rates and to begin to address the utilization of outpatient resources for RSV medically-attended lower respiratory tract infections (MALRI) in 32-35 week gestational age (GA) premature infants who are less than 6 months of age… Read more about this study
- Who is it for?
- Ages 1 month to 6 months
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- How many people
- 346 participants
- Where
- 59 sitesUnited States
- Study dates
- Oct 2006to Jan 2008
- 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 1 month to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: 2 cohorts of premature infants and premature newborns 32-35 weeks
Who may be able to join
- Parent/legal guardian able to understand and provide written informed consent
- Male or female infants born at 32-35 weeks GA. GA will be determined according to available medical records.
- Clinically stable, in the opinion of the investigator
- Ability and willingness of the subject's parent/legal guardian to complete all protocol mandated follow-up telephone calls, visits and procedures
- Not more than one of the following American Academy of Pediatrics (AAP)-defined risk factors:
- Childcare attendance
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- School-aged siblings in the home
- Exposure to environmental air pollutants (not including passive exposure to tobacco smoke)
- Congenital abnormalities of the airways
- Severe neuromuscular disease, as determined by the investigator
- Subject must meet the criteria listed below for either Cohort 1 or Cohort 2:
- Cohort 1
- Date of enrollment between 01/Oct and 15/Dec
- Chronological age of < 6 months (i.e., has not yet reached 6-month birthday) at the traditional start of the local RSV season (as used to determine eligibility for RSV prophylaxis)
- Cohort 2
- Date of enrollment between 16/Dec and 15/Feb
- Born during the current RSV season and discharged from the hospital nursery after 01/Dec
Who cannot join
- Previous (within 90 days of enrollment) or concurrent treatment with palivizumab or RSV-IGIV or IVIG
- Hospitalization at the time of enrollment (unless discharge is anticipated within 10 days)
- Two or more AAP-defined risk factors as listed under Inclusion Criteria
- Participation in trials of investigational RSV prophylaxis or therapeutic agents
- Confirmed prior or current RSV infection (a child with current signs/symptoms of respiratory infection must have negative RSV testing)
- Diagnosis of chronic lung disease (CLD) of prematurity (formerly referred to as bronchopulmonary dysplasia [BPD])
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- Diagnosis of hemodynamically significant congenital heart disease (CHD), defined as requiring medication or supplemental oxygen for their CHD
- Known immunodeficiency
- Life expectancy of < 6 months
Trial locations and contacts
59 sites in 1 country.
59 sites in 1 country
United States59 sites
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Albany Medical Center
Albany, New York, 12208
Georgia Pediatric Pulmonology Associates
Atlanta, Georgia, 30342
University of Maryland, School of Medicine
Baltimore, Maryland, 21201
Central Arkansas Pediatric Clinic, P.A.
Benton, Arkansas, 72019
St. Luke's Hospital
Bethlehem, Pennsylvania, 18015
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Beehly Medical Park Women's and Children's Pavilion
Boardman, Ohio, 44512
Tufts-New England Medical Center
Boston, Massachusetts, 02111
Boston Medical Center
Boston, Massachusetts, 02118
Carolinas Medical Center
Charlotte, North Carolina, 28203
University of Illinois at Chicago
Chicago, Illinois, 60612
Children's Memorial Hospital
Chicago, Illinois, 60614
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267
Metro Health Medical Center
Cleveland, Ohio, 44109
Driscoll Children's Hospital
Corpus Christi, Texas, 78414
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Geisinger Medical Center - JW Children's Hospital
Danville, Pennsylvania, 17822
Children's Medical Center
Dayton, Ohio, 45404
Children's Hospital
Denver, Colorado, 82018
Duke University Medical Center
Durham, North Carolina, 27710
Shands Hospital at the University of Florida
Gainesville, Florida, 32610
Raleigh Pediatric Associates
Gardner, North Carolina, 27529
Kapiolani Medical Center
Honolulu, Hawaii, 96826
University of Texas Houston Medical Center
Houston, Texas, 77030
University Physicians Internal Medicine
Huntington, West Virginia, 25701
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, 72401
Pediatric Associates of Dayton, Inc.
Kettering, Ohio, 45429
Midwest Children's Health Research Institute, LLC
Lincoln, Nebraska, 68505
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72205
Arkansas Pediatric Clinic
Little Rock, Arkansas, 72205
Little Rock Children's Clinic
Little Rock, Arkansas, 72205
Miller Children's Hospital
Long Beach, California, 90806
University of Miami Medical Center
Miami, Florida, 33136
Winthrop University Hospital
Mineola, New York, 11501
West Virginia University
Morgantown, West Virginia, 26506
Children's Hospital of Oakland
Oakland, California, 94609
Creighton University Medical Center
Omaha, Nebraska, 68198
Children's Hospital of Orange County
Orange, California, 92868
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19017
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Oregon Health & Science University
Portland, Oregon, 97239
Rhode Island Hospital
Providence, Rhode Island, 02903
Raleigh Pediatric Associates
Raleigh, North Carolina, 27615
VCU Medical Center, Children's Pavillion
Richmond, Virginia, 23298
University of Rochester Medical Center
Rochester, New York, 14624
Children's Healthcare D.B.A. Hospitals & Clinics
Saint Paul, Minnesota, 55102
Memorial Hospital of South Bend
South Bend, Indiana, 46601
Pediatrix Medical Group, St. John's Mercy Medical Center
St Louis, Missouri, 63141
Pediatric Pulmonology, LLC
Stamford, Connecticut, 06902
University Hospital, State University of New York at Stony Brook
Stony Brook, New York, 11794
Crouse Hospital NICU
Syracuse, New York, 13210
University of South Florida Pediatrics Ambulatory Care Center
Tampa, Florida, 33136
Bronx-Lebanon Hospital Center
The Bronx, New York, 10457
Jacobi Medical Center
The Bronx, New York, 10461
Montefiore Medical Center
The Bronx, New York, 10467
St. Vincent Medical Center
Toledo, Ohio, 43608
Children's Hospital Waukesha Memorial
Waukesha, Wisconsin, 53118
Children's Corporate Center
Wauwatosa, Wisconsin, 53226
About this study
Official title: A Prospective, Non-Interventional Study to Evaluate the Incidence of Hospitalizations and Medically-Attended Lower Respiratory Tract Infection (MALRI) in Premature Infants 32 to 35 Weeks Gestational Age Who Are Not Recommended to Receive Prophylaxis for RSV
The purpose of this study is to describe respiratory syncytial virus (RSV) hospitalization rates and to begin to address the utilization of outpatient resources for RSV medically-attended lower respiratory tract infections (MALRI) in 32-35 week gestational age (GA) premature infants who are less than 6 months of age and do not receive treatment.
Read the detailed description
The goals of this study are:
- To estimate the incidence of hospitalization attributable to RSV within 150 days from enrollment in premature infants who are:
- 32-35 weeks GA
- less than 6 months of age at the start of the RSV season
- not receiving palivizumab prophylaxis and not recommended to receive palivizumab according to the AAP guidelines
- To estimate the incidence rate of hospitalization attributable to RSV in the other relevant study populations and time periods (e.g., Cohort 2, Cohorts 1 and 2 combined, and subgroups based on chronological age at the start of the RSV season, GA, etc. within 150 days from enrollment and other time periods based on RSV activity, etc.)
- To estimate the incidence of RSV-associated MALRI in the study populations
- To characterize the incidence and type of clinical interventions for MALRI in the study populations
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Premature infants (32-35 weeks GA) <6 months of age at the start of the RSV season who are not receiving palivizumab and do not have CLD of prematurity, Respiratory Syncytial Viruses
- Medical subject headings
- Respiratory Syncytial Virus Infections, Premature Birth
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 | Premature Infants (32-35 wks. GA) who are less than six months of age at start of RSV season and followed until May of the following year. | |
| 2 | Premature newborns (32-35 wks. GA) who are born during the current RSV season and discharged from the hospital after 01 Dec and followed until May of the next year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the incidence of hospitalization attributable to RSV within 150 days from enrollment in premature infants
Measured: 150 days from enrollment
Secondary outcomes (2)
Estimate the incidence rate of hospitalization attributable to RSV in the other relevant study populations
Measured: 150 days after enrollment
Estimate the incidence rate of MALRI attributable to RSV in the study populations;
Measured: during follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionNov 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies 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
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Frank Malinoski, M.D., PhD, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384462
- Sponsor's protocol ID
- MI-MA140
- Status last verified
- Feb 2009
- First submitted
- 4 Oct 2006
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-Interventional Study to Evaluate the Incidence of Hospitalizations and Medically-Attended Lower Respiratory Tract Infection (MALRI) in Premature Infants 32 to 35 Weeks Gestational Age Who Are Not Recommended to Receive Prophylaxis for RSV
- ClinicalTrials.gov ID
- NCT00384462
- Acronym / sponsor ID
- MI-MA140
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Premature infants (32-35 weeks GA) <6 months of age at the start of the RSV season who are not receiving palivizumab and do not have CLD of prematurity, Respiratory Syncytial Viruses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 6 Oct 2006 (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.
The purpose of this study is to describe respiratory syncytial virus (RSV) hospitalization rates and to begin to address the utilization of outpatient resources for RSV medically-attended lower respiratory tract infections (MALRI) in 32-35 week gestational age (GA) premature infants who are less than 6 months of age and do not receive treatment.
Detailed description
The goals of this study are:
- To estimate the incidence of hospitalization attributable to RSV within 150 days from enrollment in premature infants who are:
- 32-35 weeks GA
- less than 6 months of age at the start of the RSV season
- not receiving palivizumab prophylaxis and not recommended to receive palivizumab according to the AAP guidelines
- To estimate the incidence rate of hospitalization attributable to RSV in the other relevant study populations and time periods (e.g., Cohort 2, Cohorts 1 and 2 combined, and subgroups based on chronological age at the start of the RSV season, GA, etc. within 150 days from enrollment and other time periods based on RSV activity, etc.)
- To estimate the incidence of RSV-associated MALRI in the study populations
- To characterize the incidence and type of clinical interventions for MALRI in the study populations
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Premature Infants (32-35 wks. GA) who are less than six months of age at start of RSV season and followed until May of the following year. |
| 2 | – | –Premature newborns (32-35 wks. GA) who are born during the current RSV season and discharged from the hospital after 01 Dec and followed until May of the next year. |
Who may qualify
- Ages
- 1 month to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 2 cohorts of premature infants and premature newborns 32-35 weeks
Key inclusion criteria (17 listed)
- Parent/legal guardian able to understand and provide written informed consent
- Male or female infants born at 32-35 weeks GA. GA will be determined according to available medical records.
- Clinically stable, in the opinion of the investigator
- Ability and willingness of the subject's parent/legal guardian to complete all protocol mandated follow-up telephone calls, visits and procedures
- Not more than one of the following American Academy of Pediatrics (AAP)-defined risk factors:
Key exclusion criteria (9 listed)
- Previous (within 90 days of enrollment) or concurrent treatment with palivizumab or RSV-IGIV or IVIG
- Hospitalization at the time of enrollment (unless discharge is anticipated within 10 days)
- Two or more AAP-defined risk factors as listed under Inclusion Criteria
- Participation in trials of investigational RSV prophylaxis or therapeutic agents
- Confirmed prior or current RSV infection (a child with current signs/symptoms of respiratory infection must have negative RSV testing)
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
Estimate the incidence of hospitalization attributable to RSV within 150 days from enrollment in premature infants
Time frame: 150 days from enrollment
2 secondary outcomes
Estimate the incidence rate of hospitalization attributable to RSV in the other relevant study populations
Time frame: 150 days after enrollment
Estimate the incidence rate of MALRI attributable to RSV in the study populations;
Time frame: during follow up
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 4 Feb 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.
Frank Malinoski, M.D., PhD study director
MedImmune LLC
59 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 Infections, run by MedImmune LLC at 59 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 17 inclusion and 9 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 4 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 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?
Estimate the incidence of hospitalization attributable to RSV within 150 days from enrollment in premature infants (time frame: 150 days from enrollment). 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 4 Feb 2009.