Respiratory Syncytial VirusesNCT00585481
Incidence of Severe Respiratory Syncytial Virus Infections in Preterm Brazilian Children
An observational study of Respiratory Syncytial Viruses and Respiratory Tract Infection, run by Abbott at 2 sites in Brazil.
Trial summary
The primary objective of this study is to determine the incidence of severe RSV LRTI requiring hospitalization among infants born < 35 weeks gestational age for one year of follow-up. Read more about this study
- Who is it for?
- Ages Up to 35 weeksHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Viruses, Respiratory Tract Infection
- What is being tested?
- Samples collection for viral diagnosis and Lung Function Analysis
- Type of treatment
- Surgery or procedure
- How many people
- 310 participants
- Where
- 2 sitesBrazil
- Study dates
- Jan 2008to Dec 2010
- 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 35 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants < 35 wGA born into or transferred to a participating hospital meeting all of the inclusion criteria and none of the exclusion criteria specified in the protocol will be selected to participate. Subjects will be identified in the NICU or newborn nursery and enrolled in the study 24 hours prior to confirmed hospital discharge or up to 72 hours after maternity hospital discharge date.
Who may be able to join
- Male and female infants that were born <35 weeks gestational age
- The inclusion must be done during the following period:
- 24 hours prior confirmed maternity hospital discharge date, or
- Up to 72 hours after documented maternity hospital discharge date. In this case, RSV rapid test must be performed and subjects should be enrolled only if the results is negative.
- Less than 6 months of age at screening
- Born into or transferred to a participating hospital
- Able to receive follow-up medical care at the participating site and provide information during the follow-up period
- The legal representative is capable of understanding and complying with parameters as outlined in the protocol and able and willing to participate in this study, by signing the informed consent approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), after all the aspects of the study that might be relevant for his/her decision to participate are explained and all his/her questions and doubts are elucidated, and prior to the initiation of any screening or study-specific procedures.
Who cannot join
- RSV infection prior inclusion.
- Receipt of palivizumab or other immunoglobulin preparation containing RSV specific antibodies (i.e. RSV hyperimmunoglobulin, polyclonal intravenous immunoglobulin, cytomegalovirus hyperimmunoglobulin, varicella-zoster hyperimmunoglobulin)
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Site Ref # / Investigator 6185
Curitiba, Paraná, 80060-900
Site Ref # / Investigator 6189
Ribeirão Preto, São Paulo, 14049-900
About this study
Official title: Incidence of Severe Respiratory Syncytial Virus Infections in Preterm Brazilian Children - BREVI (Brazilian Respiratory Virus in Premature Infants) Study
The primary objective of this study is to determine the incidence of severe RSV LRTI requiring hospitalization among infants born < 35 weeks gestational age for one year of follow-up.
Read the detailed description
This is an epidemiologic study of the incidence of severe RSV LRTI among Brazilian children born <35WGA. The study will enroll competitively 350 subjects from 3 sites in Brazil. Preterm children will be identified after birth and up to 72 hours after hospital discharge and followed for one year after the enrollment. Subjects will be seen monthly for the first 6 months and bimonthly until one year of follow-up. At each visit, a medical and social history will be updated and a physical examination will be performed. Legal representative will notify study personnel in the event of a respiratory illness or hospital admission at which time the subject will be seen by an investigator. Children with LRTI diagnosed by physical examination will have viral diagnostic tests performed. Subjects with a LRTI not requiring hospitalization will be followed by telephone weekly until illness resolution. Hospitalized children with a LRTI will be followed daily while hospitalized and followed by telephone until illness resolution. All medical interventions and outcomes will be recorded.
- Being tested
- Samples collection for viral diagnosis, Lung Function Analysis
- Keywords
- Epidemiological Study, Incidence of severe Respiratory Syncytial Virus, Preterm Brazilian children
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samples collection for viral diagnosisProcedure or surgery
At Enrollment and Termination Visits all subjects will have phlebotomy performed for RSV antibody levels (3 mL of blood).
Subjects diagnosed with an LRTI during the study will have a nasopharyngeal lavage (NPL) for viral diagnosis. Phlebotomy for antibody levels will be performed if the current episode represents the first LRTI since study enrollment.
Lung Function AnalysisProcedure or surgery
Subjects enrolled in one study site (located in Porto Alegre city) will perform Lung Function Analysis. First measurement will be performed up to Visit 6 and repeated at Termination Visit. Measurements collected in the first analysis will include respiratory compliance and resistance by passive deflation pressure - volume curve, lung volumes by gas dilution method (washout with SF6), lung clearance index with SF6, and maximal flows (rapid thoracic compression from raised volumes).
| Study group | Role | What they receive |
|---|---|---|
| 1 | All subjects will perform samples collection for RSV analysis. Subject's enrolled in Porto Alegre's site will perform lung function tests. Receives: Procedure: Samples collection for viral diagnosis; Procedure: Lung Function Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the incidence of severe RSV LRTI requiring hospitalization among infants born <35 weeks gestational age for one year.
Measured: 1 Year
Secondary outcomes (4)
To evaluate the risk and protective factors for severe RSV LRTI in preterm Brazilian infants.
Measured: 1 Year
To describe the seasonality of RSV infection in three cities in Brazil.
Measured: 1 Year
To compare the incidence of wheezing episodes by 12 months after maternity hospital discharge among children with and without RSV LRTI.
Measured: 1 Year
To evaluate the difference in lung function among children with and without RSV LRTI within the first year after maternity hospital discharge. Only children enrolled at one participating site will be evaluated with lung function analysis.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial VirusesStudies 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
- Time perspective
- Prospective
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Statistika Consultoria Ltda
- Responsible party
- Sponsor
- Investigators
- Lino Rodrigues, MD, Study chair, Abbott Laboratórios do Brasil Ltda.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585481
- Sponsor's protocol ID
- A07-006
- Status last verified
- Nov 2011
- First submitted
- 22 Dec 2007
- Last updated
- 19 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Severe Respiratory Syncytial Virus Infections in Preterm Brazilian Children - BREVI (Brazilian Respiratory Virus in Premature Infants) Study
- ClinicalTrials.gov ID
- NCT00585481
- Acronym / sponsor ID
- A07-006
- Keywords
- Epidemiological Study, Incidence of severe Respiratory Syncytial Virus, Preterm Brazilian children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- Statistika Consultoria Ltda
- Study start
- Jan 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Jan 2008 (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 primary objective of this study is to determine the incidence of severe RSV LRTI requiring hospitalization among infants born < 35 weeks gestational age for one year of follow-up.
Detailed description
This is an epidemiologic study of the incidence of severe RSV LRTI among Brazilian children born <35WGA. The study will enroll competitively 350 subjects from 3 sites in Brazil. Preterm children will be identified after birth and up to 72 hours after hospital discharge and followed for one year after the enrollment. Subjects will be seen monthly for the first 6 months and bimonthly until one year of follow-up. At each visit, a medical and social history will be updated and a physical examination will be performed. Legal representative will notify study personnel in the event of a respiratory illness or hospital admission at which time the subject will be seen by an investigator. Children with LRTI diagnosed by physical examination will have viral diagnostic tests performed. Subjects with a LRTI not requiring hospitalization will be followed by telephone weekly until illness resolution. Hospitalized children with a LRTI will be followed daily while hospitalized and followed by telephone until illness resolution. All medical interventions and outcomes will be recorded.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Samples collection for viral diagnosis, Procedure: Lung Function AnalysisAll subjects will perform samples collection for RSV analysis. Subject's enrolled in Porto Alegre's site will perform lung function tests. |
Who may qualify
- Ages
- Up to 35 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants < 35 wGA born into or transferred to a participating hospital meeting all of the inclusion criteria and none of the exclusion criteria specified in the protocol will be selected to participate. Subjects will be identified in the NICU or newborn nursery and enrolled in the study 24 hours prior to confirmed hospital discharge or up to 72 hours after maternity hospital discharge date.
Key inclusion criteria (8 listed)
- Male and female infants that were born <35 weeks gestational age
- The inclusion must be done during the following period:
- Less than 6 months of age at screening
- Born into or transferred to a participating hospital
- Able to receive follow-up medical care at the participating site and provide information during the follow-up period
Key exclusion criteria (2 listed)
- RSV infection prior inclusion.
- Receipt of palivizumab or other immunoglobulin preparation containing RSV specific antibodies (i.e. RSV hyperimmunoglobulin, polyclonal intravenous immunoglobulin, cytomegalovirus hyperimmunoglobulin, varicella-zoster hyperimmunoglobulin)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Samples collection for viral diagnosisAt Enrollment and Termination Visits all subjects will have phlebotomy performed for RSV antibody levels (3 mL of blood). Subjects diagnosed with an LRTI during the study will have a nasopharyngeal lavage (NPL) for viral diagnosis. Phlebotomy for antibody levels will be performed if the current episode represents the first LRTI since study enrollment. | Procedure or surgery | 1 |
| Lung Function AnalysisSubjects enrolled in one study site (located in Porto Alegre city) will perform Lung Function Analysis. First measurement will be performed up to Visit 6 and repeated at Termination Visit. Measurements collected in the first analysis will include respiratory compliance and resistance by passive deflation pressure - volume curve, lung volumes by gas dilution method (washout with SF6), lung clearance index with SF6, and maximal flows (rapid thoracic compression from raised volumes). | Procedure or surgery | 1 |
Primary outcome
To determine the incidence of severe RSV LRTI requiring hospitalization among infants born <35 weeks gestational age for one year.
Time frame: 1 Year
4 secondary outcomes
To evaluate the risk and protective factors for severe RSV LRTI in preterm Brazilian infants.
Time frame: 1 Year
To describe the seasonality of RSV infection in three cities in Brazil.
Time frame: 1 Year
To compare the incidence of wheezing episodes by 12 months after maternity hospital discharge among children with and without RSV LRTI.
Time frame: 1 Year
To evaluate the difference in lung function among children with and without RSV LRTI within the first year after maternity hospital discharge. Only children enrolled at one participating site will be evaluated with lung function analysis.
Time frame: 1 Year
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 19 Dec 2011.
- Related InfoLink provided by the sponsor.
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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.
Lino Rodrigues, MD study chair
Abbott Laboratórios do Brasil Ltda.
2 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 Viruses and Respiratory Tract Infection, run by Abbott at 2 sites in Brazil.
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 8 inclusion and 2 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 19 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
To determine the incidence of severe RSV LRTI requiring hospitalization among infants born <35 weeks gestational age for one year. (time frame: 1 Year). 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 19 Dec 2011.