Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-02-20 @ 12:58 PM
Study NCT ID:
NCT01789268
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2013-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Respiratory Pathogens in Infants
Sponsor:
University of Rochester
Organization:
Study Overview
Official Title:
Impact of Respiratory Virus Infections and Bacterial Microbiome Shifts on Lymphocyte and Respiratory Function in Infants Born Prematurely or Full Term
Status:
COMPLETED
Status Verified Date:
2022-02
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:
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 272201200005C-P00025-9999-5 | NIH | None | https://reporter.nih.gov/quic… | View |