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BMC Infect Dis. 2017 Mar 22;17(1):222. doi: 10.1186/s12879-017-2299-7.

Influenza and respiratory syncytial virus in infants study (IRIS) of hospitalized and non-ill infants aged <1 year in four countries: study design and methods.

Author information

1
Influenza Division, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA. Isq8@cdc.gov.
2
Influenza Division, MS A-32, National Center for Immunization and Respiratory Disease, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Atlanta, GA, 30333, USA. Isq8@cdc.gov.
3
Abt Associates, Inc, Atlanta, GA, USA.
4
The Eastern Mediterranean Public Health Network (EMPHNET), Amman, Jordan.
5
Department of Epidemiology & Control of Infectious Diseases, Institute of Public Health, Tirana, Albania.
6
Research Institute for Tropical Medicine, Department of Health, Muntinlupa City, Metro Manila, Philippines.
7
Division of Viral Diseases, CDC, Atlanta, GA, USA.
8
Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, MI, USA.
9
Influenza Division, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA.
10
Hospital Infantil Manuel de Jesús Rivera, Ministry of Health, Managua, Nicaragua.
11
Al-Bashir Hospital, Amman, Jordan.
12
Pediatric Hospital, University Hospital Centre, Tirana, Albania.
13
Section of Infectious Diseases, Department of Pediatrics, University of Colorado School of Medicine, Aurora, Colorado, USA.
14
Center for Global Health, Department of Epidemiology, Colorado School of Public Health, Aurora, Colorado, USA.
15
Marshfield Clinic Research Foundation, Marshfield, WI, USA.
16
Laboratorio Nacional de Virología, Centro Nacional de Diagnóstico y Referencia, Ministry of Health, Managua, Nicaragua.
17
Department of Epidemiology & Control of Infectious Diseases, Virology Laboratory, Institute of Public Health, Tirana, Albania.
18
Sustainable Sciences Institute, Managua, Nicaragua.

Abstract

BACKGROUND:

This multi-country prospective study of infants aged <1 year aims to assess the frequency of influenza virus and respiratory syncytial virus (RSV) infections associated with hospitalizations, to describe clinical features and antibody response to infection, and to examine predictors of very severe disease requiring intensive care.

METHODS/DESIGN:

We are enrolling a hospital-based cohort and a sample of non-ill infants in four countries (Albania, Jordan, Nicaragua, and the Philippines) using a common protocol. We are currently starting year 2 of a 2- to 3-year study and will enroll approximately 3,000 infants hospitalized for any acute illness (respiratory or non-respiratory) during periods of local influenza and/or RSV circulation. After informed consent and within 24 h of admission, we collect blood and respiratory specimens and conduct an interview to assess socio-demographic characteristics, medical history, and symptoms of acute illness (onset ≤10 days). Vital signs, interventions, and medications are documented daily through medical record abstraction. A follow-up health assessment and collection of convalescent blood occurs 3-5 weeks after enrollment. Influenza and RSV infection is confirmed by singleplex real time reverse transcriptase polymerase chain reaction (rRT-PCR) assays. Serologic conversion will be assessed comparing acute and convalescent sera using hemagglutination inhibition assay for influenza antibodies and enzyme-linked immunosorbent assay (ELISA) for RSV. Concurrent with hospital-based enrollment, respiratory specimens are also being collected (and tested by rRT-PCR) from approximately 1,400 non-ill infants aged <1 year during routine medical or preventive care.

DISCUSSION:

The Influenza and RSV in Infants Study (IRIS) promises to expand our knowledge of the frequency, clinical features, and antibody profiles of serious influenza and RSV disease among infants aged <1 year, quantify the proportion of infections that may be missed by traditional surveillance, and inform decisions about the potential value of existing and new vaccines and other prevention and treatment strategies.

KEYWORDS:

Burden; Hospital; Infant; Influenza; Respiratory syncytial virus; Serology

PMID:
28330443
PMCID:
PMC5361805
DOI:
10.1186/s12879-017-2299-7
[Indexed for MEDLINE]
Free PMC Article

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