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Upstate Active Clinical Trials

Study Title:

A prospective, epidemiological study to assess the disease burden of respiratory syncytial virus (RSV) associated, suspected lower respiratory tract infections (LRTIs) in newborns, from birth up to 2 years of age.

What is the purpose of the study?

Respiratory syncytial virus (RSV) is a virus (a germ) that causes diseases with breathing problems (respiratory tract infections) especially in infants and young children. It is found all over the world and almost all children get infected with RSV before they are two years old. Infections caused by RSV can range from mild infections such as a cold or a sore throat (pharyngitis) to more severe infections of the lungs such as bronchiolitis and pneumonia. The more severe infections may require hospitalization of your child. RSV is a common cause of hospitalization in children under 5 years old.
In this study we want to find out some important things about RSV such as;
▪ How often serious breathing problems caused by RSV occur in children, from birth up to 2 years of age.
▪ How much medical care is needed to treat children with breathing problems caused by RSV.
▪ How well a newly developed measurement to classify the severity of these serious breathing problems caused by RSV, works.
▪ How well and for how long a protective substance in a mother’s blood, antibody, can protect her child.
▪ How many children may have been infected with RSV without having serious breathing problems.
You have been contacted to ask if you will allow your child to take part in this study conducted by GSK Biologicals. The study will follow approximately 3000 children from several countries in different parts of the world, from birth up to 2 years of age.
Your child will not receive any vaccination or any treatment as part of this study.
The information collected during this study may help us to know more about the RSV infections.

Upstate Institutional Review Board (IRB) Number:

519740

Study/Protocol ID:

200150 (EPI-RSV-005 BOD)

Patient Age Group:

Adults and Children

Principal Investigator:

Joseph B Domachowske

Who is eligible?

Your child can only be in this study if, before his/her birth:
− You agree to follow all the activities of the study (mentioned in the section ‘what does this study involve) and agree to provide all the information required for this study.
− You have signed this consent form.
The study doctor/study staff will determine whether your child/ward can join this study.

Your child can only be in this study if, after his/her birth:
− You have re-signed this consent form.
− He/she is a newborn of at least 28 weeks of pregnancy.
− He/she is not born with a serious disease or birth defect.
− A blood sample of at least 3 millilitres from the umbilical cord was collected from your child after birth.
The study doctor/study staff will also confirm whether your child can join this study.
You can ask your study doctor/study staff for more details.

Who can I contact for more information?

Name: Maureen J Butler
Phone: 315-464-9441
Email: butlermj@upstate.edu

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