NCT01789268

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
267

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 12, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

March 27, 2013

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

6.8 years

First QC Date

February 7, 2013

Last Update Submit

February 11, 2022

Conditions

Respiratory Tract Infection

Keywords

acuteadaptive cellular immune phenotypesinfantsLymphocyteprematurerespiratory viral infections

Outcome Measures

Primary Outcomes (14)

  • 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

    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

    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

    From 41 weeks gestation through 3 years CGA

  • Etiology of symptomatic viral respiratory infections as assessed by TLDA PCR Assays of biospecimens

    2 years CGA

  • Number of respiratory tract symptomatic and asymptomatic viral infections weekly.

    41weeks gestation

  • Number of symptomatic viral respiratory infections

    2 years CGA

  • Occurrence of respiratory tract viral infections (asymptomatic and symptomatic)

    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

    41 weeks gestation

  • Pulmonary function via Respiratory Inductive Plethysmography (RIP) with Bronchodilator Response (BDR)

    41 weeks gestation

  • Rate of adaptive immune system maturation utilizing flow cytometric analysis of lymphocytes in blood

    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

    41 weeks gestation

  • Severity of illness due to viral respiratory tract infections

    2 years CGA

  • Severity of respiratory tract viral infections (asymptomatic and symptomatic) as assessed by the COAST Respiratory Symptom Scale.

    2 years CGA

  • Viral load of respiratory pathogens in the nasopharynx of infants with symptomatic RTIs

    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

    Through the first 1 year CGA

  • Presence of cord blood antigen-neutralizing antibodies correlates with the presence of specific antigen responses in lymphocytes

    At term or near term gestation

  • Pulmonary function via RIP with BDR

    At 1 year CGA and 3 years CGA

  • Titers of neutralizing antibodies in cord blood to isolated viral pathogens

    Through the first 2 years CGA

Study Arms (2)

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

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

Device: Respiratory Inductive Plethysmography

Interventions

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)

Full-Term Healthy Infants (> /=37 weeks gestational age)Preterm Infants (<36 weeks gestational age)

Eligibility Criteria

Age0 Days - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Study subjects were enrolled from sequential preterm and full term births at the University of Rochester

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases

Rochester, New York, 14642-0001, United States

Location

Related Publications (2)

  • 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.

    PMID: 33948240RESULT

  • Caserta 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.

    PMID: 31377041RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Urine, blood plasma, blood cells, saliva

MeSH Terms

Conditions

Respiratory Tract InfectionsPremature Birth

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 7, 2013

First Posted

February 12, 2013

Study Start

March 27, 2013

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations

US(1)