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Impact of Respiratory Pathogens in Infants

NCT01789268 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 267

Last updated 2022-03-02

No results posted yet for this study

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.

Conditions

  • Respiratory Tract Infection

Interventions

DEVICE

Respiratory Inductive Plethysmography

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)

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of Rochester

    lead OTHER

Eligibility

Min Age
0 Days
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-27
Primary Completion
2019-12-31
Completion
2019-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01789268 on ClinicalTrials.gov