Common Questions:

1. What is the study trying to learn?
   • The goal of the study is to find out how best to help children on a breathing machine with a serious lung injury. We want to learn what kinds of positioning and breathing machines work best for children. We also want to learn more about how children do after they go home from the PICU (Pediatric Intensive Care Unit).
2. What benefit is there for my child to be in this study?
   • Your child could receive a position or kind of breathing support that may not have been selected for them by the medical care team that will shorten their time on the ventilator. We do not know yet which type of position or breathing support is best.
3. Is this study only while my child is in the hospital?
   • If you live in the US, we will be following up with you for one year after your child leaves leave the PICU. There will be 4 follow-up surveys to complete. The follow-up will take place over the phone and online using surveys at 1 month, 3 months, 6 months, and 12 months after they leave the PICU to check on how your child is doing. You will not have to come back to the hospital for this part of the study.
   • If you live outside of the US, the study takes place only while your child is in the hospital.
4. What happens when my child is discharged from the hospital/PICU?
   • If you live in the US, we will be following up with you for one year after your child leaves leave the PICU. We will contact you 2 weeks after your child is released from the PICU to confirm that your contact information is correct.
   • There are then 4 follow-up surveys. The follow-up will take place over the phone and online via surveys at 2 weeks, 1 month, 3 months, 6 months, and 12 months after they leave the PICU to check on how your child is doing. You will not have to come back to the hospital.
5. What if I don’t have internet access at home?
   • We can help you to complete the study follow-up surveys over the phone. If you have email, you can complete the surveys anywhere that you can access email.
6. How long will I be in this study?
   • For the time that your child is in the hospital and, if you live in the US, one year after.
7. How is this study different than normal care my child would receive?
   • It is not very different each of the position and breathing support therapies are used by the medical team caring for your child. We currently do not know which of these therapies are best for children like yours. If you child was not in the study the care team would choose which therapies to use. The study will decide which therapies your child receives.
8. What if we move?
   • If you move, we ask that you please contact the PROSpect CCC at ccc@prospect-network.org or 215-898-4151 to let them know your new address and contact information.
9. Will I receive any study results when the study is over?
   • The study results that are published will be about the group of subjects in the study, not individual subjects.
10. Is providing a blood sample optional?
    • Yes, this is an optional part of the study that can you say yes or no to. To help us understand more about children with this type of lung illness we would like to collect blood samples.
11. How many times will my child provide a blood sample?
    • This depends on how much your child weighs. There will be a minimum of 6 blood samples taken from an existing IV line and a maximum of 10. Smaller children will provide fewer samples.
12. Do I have to allow my child to provide all the blood samples?
    • No, you can stop blood collection at any time.
13. Will my child have a needle poke to provide blood samples?
    • Blood will be collected from an already-existing line. So, it is not likely that we will need an additional needle poke to collect blood throughout the study.
14. Who pays for this study?
    • The study is paid for by the National Institutes of Health, National Heart Lung Blood Institute (NIH-NHLBI), funded by the Department of Health and Human Services (DHHS).
15. Do I have to pay for the study?
    • No.
16. Will you charge my insurance for this study?
    • No.
17. Do I have to pay anything to be in the study after my child leaves the hospital?
    • No.
18. Do I get paid for being in this study?
    • If you complete the four follow-up surveys of the study, you will receive $50 on a debit card.
19. Is this study risky for my child?
    • Your child is at no increased risk during this study as the position and breathing machine therapies provided are the same as those already used to treat children in your PICU with serious lung injury.
20. Will the people who care for my child be upset if I don’t participate?
    • No, you do not have to participate, and no one will be upset if you choose not to.
21. Will any study procedures be painful?
    • Sometimes routine care in the PICU can be painful or uncomfortable, like suctioning. This care would occur even if your child was not in the study. Your nurses and doctors always try to reduce or prevent pain. Unless your child requires a needle poke for a blood sample, which is very unlikely, there should not be any painful procedures for the study.
22. Who should I call first if I change my mind?
    • Call the PROSpect CCC at 215-898-4151 and the CCC will immediately contact your study lead at your hospital.
23. Why was my child selected for this study?
    • Your child was selected because they are the right age and have the type of illness in their lungs that we are studying how best to treat.and Your child’s doctor believes that they will be a good candidate.
24. What if I change my mind?
    • You can change your mind and stop being in the study at any time. Please tell your child’s doctor (care team?) or call the CCC at 215-898-4151.
25. What information about my child does the study keep?
    • The study keeps your child’s medical information, like dates, the name of your child’s illness, and medication your child receives.
26. Will anyone know that my child was in this study?
    • Only you, your child, your child’s study team in the hospital, and the study team at the University of Pennsylvania will know that your child was in this study.
27. Is my information kept private?
    • Your information will not be shared with anyone outside of the study.