Respiratory Tract InfectionNCT01789268
Impact of Respiratory Pathogens in Infants
An observational study of Respiratory Tract Infection, run by University of Rochester at 1 site in United States.
Trial summary
This clinical study will investigate the relationships between sequential respiratory viral infections, patterns of intestinal and respiratory bacterial colonization, and adaptive cellular immune phenotypes which are associated with increased susceptibility to respiratory infections and long term respiratory morbidity… Read more about this study
- Who is it for?
- Ages 0 days to 3 years
- Conditions the study is for
- Respiratory Tract Infection
- What is being tested?
- Respiratory Inductive Plethysmography
- Type of treatment
- Medical device
- How many people
- 267 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2013to 31 Dec 2019
- 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 0 days to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: Study subjects were enrolled from sequential preterm and full term births at the University of Rochester
Who may be able to join
- Inclusion Criteria for Preterm Cohort: - Signed Informed Consent from parent(s) or legal guardian(s) - Preterm infants born at gestational age 23 0/7 to 35 6/7 weeks - Preterm infants admitted to the URMC NICU or Normal Newborn Nursery - Infants less than or equal to 7 days old - Attending physician agreement Inclusion Criteria for Full Term Cohort: - Healthy term infants 37 0/7 to 41 6/7 weeks gestation - Recruited prior to delivery, or from the birthing centers and labor and delivery floor at URMC and Highland Hospital - Infants less than or equal to 7 days old - Signed Informed Consent from parent(s) or legal guardian(s)
Who cannot join
- Considered to be non-viable (decision made by clinical care team to not provide life-saving therapies) - Known congenital heart disease, not including patent ductus arteriosus (PDA), hemodynamically insignificant ventricular septal defect (VSD) or atrial septal defect (ASD) - Known structural abnormalities of the upper airway, lungs, or chest wall - Known other congenital malformations or syndromes that adversely affect life expectancy or cardiopulmonary development (i.e., neuromuscular disease, trisomy 21) - Known to be born to women who are human immunodeficiency virus (HIV) positive (HIV testing is not required prior to study entry but is available for most mothers-to-be and is performed on all newborns in NY state) - Known congenital or acquired immune deficiency - Family is unlikely to be available for long-term follow-up as determined by the site investigators - No legal guardian who speaks and reads English - Specifically for the term Infants, as healthy infants, they will not have been admitted to the URMC NICU prior to consent. - Any infant with a diagnosis of hypertension, hyperthyroidism, seizures, arrhythmias, or sensitivity to sympathomimetic amines will be excluded from the BDR assessment. - Any infant with hypersensitivity to any of components of albuterol sulfate will be excluded from the BDR assessment. An infant or child with such history may remain eligible for the remainder of the study if they qualify by other inclusion and exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases
Rochester, New York, 14642-0001
About this study
Official title: Impact of Respiratory Virus Infections and Bacterial Microbiome Shifts on Lymphocyte and Respiratory Function in Infants Born Prematurely or Full Term
This clinical study will investigate the relationships between sequential respiratory viral infections, patterns of intestinal and respiratory bacterial colonization, and adaptive cellular immune phenotypes which are associated with increased susceptibility to respiratory infections and long term respiratory morbidity in preterm and full term infants. This is a prospective, cohort study, enrolling at a single center via two sites (URMC and URMC-affiliated Highland Hospital and Rochester General Hospital). Enrollment will be accomplished in approximately 15 - 36 months. The study will enroll 280 subjects, 150 pre-term and 130 full-term.
Read the detailed description
This clinical study will investigate the relationships between sequential respiratory viral infections, patterns of intestinal and respiratory bacterial colonization, and adaptive cellular immune phenotypes which are associated with increased susceptibility to respiratory infections and long term respiratory morbidity in preterm and full term infants. This is a prospective, cohort study, enrolling at a single center via two sites (URMC and URMC-affiliated Highland Hospital and Rochester General Hospital). Enrollment will be accomplished in approximately 15 - 36 months. The study will enroll 280 subjects, 150 pre-term and 130 full-term. This protocol does not study an agent or intervention. However, the bronchodilator, albuterol, a beta 2 agonist, will be administered as part of the Respiratory Inductive Plethysmography (RIP) pulmonary function assessments. All infants will remain in the study up to 3 years plus 17 weeks, depending on gestational age at birth. The full-term infants are expected to be typically developing newborns and generally healthy. Enrolled newborns will have a sample of cord blood (CB) for evaluation of lymphocyte phenotype and baseline neutralizing antibody titers. Maternal saliva samples will be collected to test exposure to environmental tobacco smoke. A nose, throat and rectal swab will be obtained for the assessment of the respiratory and gut microbiome and testing for known respiratory pathogens and pathogen discovery. Prior to hospital discharge, infants will have an evaluation of lymphocyte phenotype and function, and will undergo a respiratory assessment via RIP prior to and after a bronchodilator. Co-morbidities, familial and environmental risk factors for atopy, asthma and respiratory symptoms will be assessed. Following hospital discharge, all babies (full-term and former preterm infants) will be followed longitudinally through 3 years CGA as outpatients. During the first year of follow-up, all infants will have rectal and nose, throat swabs obtained monthly. Screening for symptomatic respiratory dysfunction and illnesses will also occur during the time of follow-up as per schedule.
- Conditions
- Respiratory Tract Infection
- Being tested
- Respiratory Inductive Plethysmography
- Keywords
- acute, adaptive cellular immune phenotypes, infants, Lymphocyte, premature, respiratory viral infections
- Medical subject headings
- Respiratory Tract Infections, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Inductive PlethysmographyDevice
Respiratory Inductive Plethysmography (RIP) will be used to document thoracoabdominal motion, relative minute ventilation, and apnea during the minimally invasive respiratory assessments (NIRAs). Both Full and Preterm Infants will undergo a respiratory assessment via RIP prior to and after a bronchodilator (albuterol)
| Study group | Role | What they receive |
|---|---|---|
| Full-Term Healthy Infants (> /=37 weeks gestational age) | 130 male and female term infants born at a gestational age of 37 0/7 to 41 6/7 weeks (Healthy comparator) will be observed for sequential respiratory viral infections, patterns of intestinal and respiratory bacterial colonization, and adaptive cellular immune phenotypes which are associated with increased susceptibility to respiratory infections and long term respiratory morbidity Receives: Device: Respiratory Inductive Plethysmography | |
| Preterm Infants (<36 weeks gestational age) | 150 male and female preterm infants born at gestational age 23 0/7 to 35 6/7 weeks will be observed for sequential respiratory viral infections, patterns of intestinal and respiratory bacterial colonization, and adaptive cellular immune phenotypes which are associated with increased susceptibility to respiratory infections and long term respiratory morbidity Receives: Device: Respiratory Inductive Plethysmography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculate presence of at/near term gestation cellular immune response to mitogen and antigen specific responses to > /=1 viral pathogens isolated over 1st 2yrs CGA via lymphocyte assessment
Measured: 2 years CGA
Degree of adaptive immune system maturation utilizing flow cytometric analysis of lymphocytes in blood
Assess blood lymphocyte subsets at birth (cord blood), discharge and at 1 year of age
Measured: From 41 weeks gestation through 3 years CGA
Degree of immune system maturation utilizing flow cytometric analysis of lymphocytes in umbilical cord blood and peripheral blood
Measured: From 41 weeks gestation through 3 years CGA
Etiology of symptomatic viral respiratory infections as assessed by TLDA PCR Assays of biospecimens
Measured: 2 years CGA
Number of respiratory tract symptomatic and asymptomatic viral infections weekly.
Measured: 41weeks gestation
Number of symptomatic viral respiratory infections
Measured: 2 years CGA
Occurrence of respiratory tract viral infections (asymptomatic and symptomatic)
Measured: From 37- 41 weeks gestation, through the first 1 and 2 years CGA, respectively
Patterns of respiratory and gut bacterial microbiome as they develop weekly
Measured: 41 weeks gestation
Pulmonary function via Respiratory Inductive Plethysmography (RIP) with Bronchodilator Response (BDR)
Measured: 41 weeks gestation
Rate of adaptive immune system maturation utilizing flow cytometric analysis of lymphocytes in blood
Measured: From 37- 41 weeks, through the first 1 and 3 years CGA
Rate of immune system maturation utilizing flow cytometric analysis of lymphocytes in umbilical cord blood and peripheral blood
Measured: 41 weeks gestation
Severity of illness due to viral respiratory tract infections
Measured: 2 years CGA
Severity of respiratory tract viral infections (asymptomatic and symptomatic) as assessed by the COAST Respiratory Symptom Scale.
Measured: 2 years CGA
Viral load of respiratory pathogens in the nasopharynx of infants with symptomatic RTIs
Measured: 2 years CGA
Secondary outcomes (4)
Patterns of respiratory and gut bacterial microbiome as they change monthly from hospital discharge at term or near term gestation
Measured: Through the first 1 year CGA
Presence of cord blood antigen-neutralizing antibodies correlates with the presence of specific antigen responses in lymphocytes
Measured: At term or near term gestation
Pulmonary function via RIP with BDR
Measured: At 1 year CGA and 3 years CGA
Titers of neutralizing antibodies in cord blood to isolated viral pathogens
Measured: Through the first 2 years CGA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study start27 Mar 2013
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract InfectionStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gloria Pryhuber, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789268
- Sponsor's protocol ID
- 12-0012
- Other IDs
- 272201200005C-P00025-9999-5
- Status last verified
- Feb 2022
- First submitted
- 7 Feb 2013
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
McDavid A, Corbett AM, Dutra JL, Straw AG, Topham DJ, Pryhuber GS, Caserta MT, Gill SR, Scheible KM, Holden-Wiltse J. Eight practices for data management to enable team data science. J Clin Transl Sci. 2020 Jun 23;5(1):e14. doi: 10.1017/cts.2020.501.
PubMed 33948240Caserta MT, Yang H, Bandyopadhyay S, Qiu X, Gill SR, Java J, McDavid A, Falsey AR, Topham DJ, Holden-Wiltse J, Scheible K, Pryhuber G. Measuring the Severity of Respiratory Illness in the First 2 Years of Life in Preterm and Term Infants. J Pediatr. 2019 Nov;214:12-19.e3. doi: 10.1016/j.jpeds.2019.06.061. Epub 2019 Jul 31.
PubMed 31377041
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Respiratory Virus Infections and Bacterial Microbiome Shifts on Lymphocyte and Respiratory Function in Infants Born Prematurely or Full Term
- ClinicalTrials.gov ID
- NCT01789268
- Acronym / sponsor ID
- 12-0012
- Conditions
- Respiratory Tract Infection
- Keywords
- acute, adaptive cellular immune phenotypes, infants, Lymphocyte, premature, respiratory viral infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 27 Mar 2013 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 12 Feb 2013 (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.
This clinical study will investigate the relationships between sequential respiratory viral infections, patterns of intestinal and respiratory bacterial colonization, and adaptive cellular immune phenotypes which are associated with increased susceptibility to respiratory infections and long term respiratory morbidity in preterm and full term infants. This is a prospective, cohort study, enrolling at a single center via two sites (URMC and URMC-affiliated Highland Hospital and Rochester General Hospital). Enrollment will be accomplished in approximately 15 - 36 months. The study will enroll 280 subjects, 150 pre-term and 130 full-term.
Detailed description
This clinical study will investigate the relationships between sequential respiratory viral infections, patterns of intestinal and respiratory bacterial colonization, and adaptive cellular immune phenotypes which are associated with increased susceptibility to respiratory infections and long term respiratory morbidity in preterm and full term infants. This is a prospective, cohort study, enrolling at a single center via two sites (URMC and URMC-affiliated Highland Hospital and Rochester General Hospital). Enrollment will be accomplished in approximately 15 - 36 months. The study will enroll 280 subjects, 150 pre-term and 130 full-term. This protocol does not study an agent or intervention. However, the bronchodilator, albuterol, a beta 2 agonist, will be administered as part of the Respiratory Inductive Plethysmography (RIP) pulmonary function assessments. All infants will remain in the study up to 3 years plus 17 weeks, depending on gestational age at birth. The full-term infants are expected to be typically developing newborns and generally healthy. Enrolled newborns will have a sample of cord blood (CB) for evaluation of lymphocyte phenotype and baseline neutralizing antibody titers. Maternal saliva samples will be collected to test exposure to environmental tobacco smoke. A nose, throat and rectal swab will be obtained for the assessment of the respiratory and gut microbiome and testing for known respiratory pathogens and pathogen discovery. Prior to hospital discharge, infants will have an evaluation of lymphocyte phenotype and function, and will undergo a respiratory assessment via RIP prior to and after a bronchodilator. Co-morbidities, familial and environmental risk factors for atopy, asthma and respiratory symptoms will be assessed. Following hospital discharge, all babies (full-term and former preterm infants) will be followed longitudinally through 3 years CGA as outpatients. During the first year of follow-up, all infants will have rectal and nose, throat swabs obtained monthly. Screening for symptomatic respiratory dysfunction and illnesses will also occur during the time of follow-up as per schedule.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full-Term Healthy Infants (> /=37 weeks gestational age) | – | Device: Respiratory Inductive Plethysmography130 male and female term infants born at a gestational age of 37 0/7 to 41 6/7 weeks (Healthy comparator) will be observed for sequential respiratory viral infections, patterns of intestinal and respiratory bacterial colonization, and adaptive cellular immune phenotypes which are associated with increased susceptibility to respiratory infections and long term respiratory morbidity |
| Preterm Infants (<36 weeks gestational age) | – | Device: Respiratory Inductive Plethysmography150 male and female preterm infants born at gestational age 23 0/7 to 35 6/7 weeks will be observed for sequential respiratory viral infections, patterns of intestinal and respiratory bacterial colonization, and adaptive cellular immune phenotypes which are associated with increased susceptibility to respiratory infections and long term respiratory morbidity |
Who may qualify
- Ages
- 0 days to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Study subjects were enrolled from sequential preterm and full term births at the University of Rochester
Key inclusion criteria (1 listed)
- Inclusion Criteria for Preterm Cohort: - Signed Informed Consent from parent(s) or legal guardian(s) - Preterm infants born at gestational age 23 0/7 to 35 6/7 weeks - Preterm infants admitted to the URMC NICU or Normal Newborn Nursery - Infants less than or equal to 7 days old - Attending physician agreement Inclusion Criteria for Full Term Cohort: - Healthy term infants 37 0/7 to 41 6/7 weeks gestation - Recruited prior to delivery, or from the birthing centers and labor and delivery floor at URMC and Highland Hospital - Infants less than or equal to 7 days old - Signed Informed Consent from parent(s) or legal guardian(s)
Key exclusion criteria (1 listed)
- Considered to be non-viable (decision made by clinical care team to not provide life-saving therapies) - Known congenital heart disease, not including patent ductus arteriosus (PDA), hemodynamically insignificant ventricular septal defect (VSD) or atrial septal defect (ASD) - Known structural abnormalities of the upper airway, lungs, or chest wall - Known other congenital malformations or syndromes that adversely affect life expectancy or cardiopulmonary development (i.e., neuromuscular disease, trisomy 21) - Known to be born to women who are human immunodeficiency virus (HIV) positive (HIV testing is not required prior to study entry but is available for most mothers-to-be and is performed on all newborns in NY state) - Known congenital or acquired immune deficiency - Family is unlikely to be available for long-term follow-up as determined by the site investigators - No legal guardian who speaks and reads English - Specifically for the term Infants, as healthy infants, they will not have been admitted to the URMC NICU prior to consent. - Any infant with a diagnosis of hypertension, hyperthyroidism, seizures, arrhythmias, or sensitivity to sympathomimetic amines will be excluded from the BDR assessment. - Any infant with hypersensitivity to any of components of albuterol sulfate will be excluded from the BDR assessment. An infant or child with such history may remain eligible for the remainder of the study if they qualify by other inclusion and exclusion criteria.
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 |
|---|---|---|
| Respiratory Inductive PlethysmographyRespiratory Inductive Plethysmography (RIP) will be used to document thoracoabdominal motion, relative minute ventilation, and apnea during the minimally invasive respiratory assessments (NIRAs). Both Full and Preterm Infants will undergo a respiratory assessment via RIP prior to and after a bronchodilator (albuterol) | Device | Full-Term Healthy Infants (> /=37 weeks gestational age), Preterm Infants (<36 weeks gestational age) |
Primary outcome
Calculate presence of at/near term gestation cellular immune response to mitogen and antigen specific responses to > /=1 viral pathogens isolated over 1st 2yrs CGA via lymphocyte assessment
Time frame: 2 years CGA
Degree of adaptive immune system maturation utilizing flow cytometric analysis of lymphocytes in blood
Time frame: From 41 weeks gestation through 3 years CGA
Assess blood lymphocyte subsets at birth (cord blood), discharge and at 1 year of age
Degree of immune system maturation utilizing flow cytometric analysis of lymphocytes in umbilical cord blood and peripheral blood
Time frame: From 41 weeks gestation through 3 years CGA
Etiology of symptomatic viral respiratory infections as assessed by TLDA PCR Assays of biospecimens
Time frame: 2 years CGA
Number of respiratory tract symptomatic and asymptomatic viral infections weekly.
Time frame: 41weeks gestation
Number of symptomatic viral respiratory infections
Time frame: 2 years CGA
Occurrence of respiratory tract viral infections (asymptomatic and symptomatic)
Time frame: From 37- 41 weeks gestation, through the first 1 and 2 years CGA, respectively
Patterns of respiratory and gut bacterial microbiome as they develop weekly
Time frame: 41 weeks gestation
Pulmonary function via Respiratory Inductive Plethysmography (RIP) with Bronchodilator Response (BDR)
Time frame: 41 weeks gestation
Rate of adaptive immune system maturation utilizing flow cytometric analysis of lymphocytes in blood
Time frame: From 37- 41 weeks, through the first 1 and 3 years CGA
Rate of immune system maturation utilizing flow cytometric analysis of lymphocytes in umbilical cord blood and peripheral blood
Time frame: 41 weeks gestation
Severity of illness due to viral respiratory tract infections
Time frame: 2 years CGA
Severity of respiratory tract viral infections (asymptomatic and symptomatic) as assessed by the COAST Respiratory Symptom Scale.
Time frame: 2 years CGA
Viral load of respiratory pathogens in the nasopharynx of infants with symptomatic RTIs
Time frame: 2 years CGA
4 secondary outcomes
Patterns of respiratory and gut bacterial microbiome as they change monthly from hospital discharge at term or near term gestation
Time frame: Through the first 1 year CGA
Presence of cord blood antigen-neutralizing antibodies correlates with the presence of specific antigen responses in lymphocytes
Time frame: At term or near term gestation
Pulmonary function via RIP with BDR
Time frame: At 1 year CGA and 3 years CGA
Titers of neutralizing antibodies in cord blood to isolated viral pathogens
Time frame: Through the first 2 years CGA
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 2 Mar 2022.
- Results publication: PubMed 33948240McDavid A, Corbett AM, Dutra JL, Straw AG, Topham DJ, Pryhuber GS, Caserta MT, Gill SR, Scheible KM, Holden-Wiltse J. Eight practices for data management to enable team data science. J Clin Transl Sci. 2020 Jun 23;5(1):e14. doi: 10.1017/cts.2020.501.
- Results publication: PubMed 31377041Caserta MT, Yang H, Bandyopadhyay S, Qiu X, Gill SR, Java J, McDavid A, Falsey AR, Topham DJ, Holden-Wiltse J, Scheible K, Pryhuber G. Measuring the Severity of Respiratory Illness in the First 2 Years of Life in Preterm and Term Infants. J Pediatr. 2019 Nov;214:12-19.e3. doi: 10.1016/j.jpeds.2019.06.061. Epub 2019 Jul 31.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Tract Infection, run by University of Rochester at 1 site 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 1 inclusion and 1 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 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Calculate presence of at/near term gestation cellular immune response to mitogen and antigen specific responses to > /=1 viral pathogens isolated over 1st 2yrs CGA via lymphocyte assessment (time frame: 2 years CGA). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01789268, which also lists 2 linked publications.
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 2 Mar 2022.