Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424795
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2024-05-16
Brief Title:
Molecular and MicrobiomeMetagenome Correlates of Recurrent Wheeze in RSV Infected Infants
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Molecular and MicrobiomeMetagenome Correlates of Recurrent Wheeze in RSV Infected Infants
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to learn about further wheezing in infants with RSV infection The main question it aims to answer is
If infant factors the infant immune response in the nose and the bacteria that reside in the nose at the time of primary RSV infection can predictclassify infants with recurrent wheezing during the following year
A secondary aim is to identify infant immune response factors in the nose and patterns of bacteria in the nose during primary RSV infection that may help us understand why recurrent wheezing occurs
Researchers will compare infants with repeated episodes of wheezing to infants who do not have further wheezing
Participants will be full term infants with their first RSV infection We will collect information on the pregnancy and birth history as well as the signs and symptoms of RSV infection Two nasal swabs and a nasal wash will be collected from the infants Six weeks following the RSV infection we will begin contact with the families biweekly to determine if the infant has recurrent wheezing confirmed by a medical provider Follow-up will continue for approximately 1 year through a second winter season
If infant factors the infant immune response in the nose and the bacteria that reside in the nose at the time of primary RSV infection can predictclassify infants with recurrent wheezing during the following year
A secondary aim is to identify infant immune response factors in the nose and patterns of bacteria in the nose during primary RSV infection that may help us understand why recurrent wheezing occurs
Researchers will compare infants with repeated episodes of wheezing to infants who do not have further wheezing
Participants will be full term infants with their first RSV infection We will collect information on the pregnancy and birth history as well as the signs and symptoms of RSV infection Two nasal swabs and a nasal wash will be collected from the infants Six weeks following the RSV infection we will begin contact with the families biweekly to determine if the infant has recurrent wheezing confirmed by a medical provider Follow-up will continue for approximately 1 year through a second winter season
Detailed Description:
Respiratory syncytial virus RSV causes yearly epidemics of respiratory infection with a significant burden of disease in those at the extremes of age Infants with RSV infection develop a range of illness from mild or in apparent upper respiratory infections to severe lower respiratory disease with wheezing andor pneumonia RSV infection is the most common cause of hospitalization in infants in the US
The great majority 85 of hospitalized infants are diagnosed with bronchiolitis and 78 are noted to have wheezing RSV infection leads to even greater outpatient utilization of medical care including Emergency Department visits 39-69 per 1000 under 6 months and 45-68 per 1000 from 6-11 months and visits to pediatricians 108-1571000 under 6 months and 160-194 per 1000 from 6-11 months
Following primary RSV infection several epidemiological observations have identified an increased frequency of recurrent wheezing in 34 to 56 of infants
The objectives of this study include
Primary Objective To test whether clinical factors airway gene expression and microbiomemetagenome patterns in the nasal epithelium at the time of primary RSV infection can predictclassify infants with recurrent wheezing
Secondary Objective 1 To identify airway gene expression and microbiomemetagenome correlates of primary RSV infection that may inform pathogenic mechanisms associated with recurrent wheeze
Hypotheses
Primary Hypothesis Infants with recurrent wheeze following primary RSV infection will have a defined set of clinical airway gene expression andor airway microbiomemetagenome characteristics associated with a post bronchial wheezing phenotype
Secondary Hypothesis 1 Respiratory epithelial innate immune responses to primary RSV infection and their interaction with microbiome composition and functional processes will identify biological mechanisms contributing to post bronchial wheeze
This is a single center prospective case-control observational study Full term 36 and 07 gestation infants born after the prior RSV season of the prior year with primary RSV infection and no prior episodes of wheezing will be enrolled during their first RSV season from both outpatient and inpatient locations in Rochester New York During the subsequent seasons of enrollment infants will meet the above eligibility requirements and also be tested and negative for acute infection with Severe Acute Respiratory Syndrome-Coronavirus-2100 infants total with RSV infection will be enrolled with approximately 50 from the hospital and 50 from the Emergency Department ED or outpatient clinic in order to enroll infants with a range of severity but with a focus on those presenting for medical care due to symptoms Active surveillance for subsequent wheezing episodes will be conducted by phonetextemail follow-up every two weeks over the subsequent year including a second full winter season for all subjects beginning six weeks after the index illness At the first report of subsequent wheezing a research clinic or home visit will be conducted to confirm the presence of wheezing by a trained staff member Recurrent wheeze will be defined by two separate episodes of wheezing separated by at least 14 days with the first episode confirmed by study staff In addition to this active surveillance caregivers will be asked to sign a medical records release for their child at the first visit that will cover the period of participation in the study At the end of the study we will review each subjects medical records to determine if the child has had wheezing documented by a medical provider and not reported by the family Once recurrent wheeze has been confirmed the subject will have reached an endpoint At the end of the follow-up period the clinical and biological characteristics of participants with recurrent wheeze and those without recurrent wheeze will be compared
The great majority 85 of hospitalized infants are diagnosed with bronchiolitis and 78 are noted to have wheezing RSV infection leads to even greater outpatient utilization of medical care including Emergency Department visits 39-69 per 1000 under 6 months and 45-68 per 1000 from 6-11 months and visits to pediatricians 108-1571000 under 6 months and 160-194 per 1000 from 6-11 months
Following primary RSV infection several epidemiological observations have identified an increased frequency of recurrent wheezing in 34 to 56 of infants
The objectives of this study include
Primary Objective To test whether clinical factors airway gene expression and microbiomemetagenome patterns in the nasal epithelium at the time of primary RSV infection can predictclassify infants with recurrent wheezing
Secondary Objective 1 To identify airway gene expression and microbiomemetagenome correlates of primary RSV infection that may inform pathogenic mechanisms associated with recurrent wheeze
Hypotheses
Primary Hypothesis Infants with recurrent wheeze following primary RSV infection will have a defined set of clinical airway gene expression andor airway microbiomemetagenome characteristics associated with a post bronchial wheezing phenotype
Secondary Hypothesis 1 Respiratory epithelial innate immune responses to primary RSV infection and their interaction with microbiome composition and functional processes will identify biological mechanisms contributing to post bronchial wheeze
This is a single center prospective case-control observational study Full term 36 and 07 gestation infants born after the prior RSV season of the prior year with primary RSV infection and no prior episodes of wheezing will be enrolled during their first RSV season from both outpatient and inpatient locations in Rochester New York During the subsequent seasons of enrollment infants will meet the above eligibility requirements and also be tested and negative for acute infection with Severe Acute Respiratory Syndrome-Coronavirus-2100 infants total with RSV infection will be enrolled with approximately 50 from the hospital and 50 from the Emergency Department ED or outpatient clinic in order to enroll infants with a range of severity but with a focus on those presenting for medical care due to symptoms Active surveillance for subsequent wheezing episodes will be conducted by phonetextemail follow-up every two weeks over the subsequent year including a second full winter season for all subjects beginning six weeks after the index illness At the first report of subsequent wheezing a research clinic or home visit will be conducted to confirm the presence of wheezing by a trained staff member Recurrent wheeze will be defined by two separate episodes of wheezing separated by at least 14 days with the first episode confirmed by study staff In addition to this active surveillance caregivers will be asked to sign a medical records release for their child at the first visit that will cover the period of participation in the study At the end of the study we will review each subjects medical records to determine if the child has had wheezing documented by a medical provider and not reported by the family Once recurrent wheeze has been confirmed the subject will have reached an endpoint At the end of the follow-up period the clinical and biological characteristics of participants with recurrent wheeze and those without recurrent wheeze will be compared
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None