PREVAIL FAQ’s.doc V. 1.0 

PREVAIL FAQs: 

Will my baby be getting new vaccines? 

This study is an observational study, so we will not be giving you or your baby any medications or vaccines for this study. 

What if I don’t want my baby to get any vaccines?

Since your baby will not be receiving any vaccines (shots) as part of this study, you should discuss your child’s vaccines 

with his/her Pediatrician. Your child can still participate in this study even if you choose to not vaccinate your child. 

What will happen if I forget to respond to a text? (Or, how often will I get text reminders?) 

The text message for each week will be sent 3 times to remind you to complete the questionnaire. You will receive the 

text once a day for 3 days. If a questionnaire is not completed after the 3rd day, that week’s questionnaire will no 

longer be available for completion. 

What happens if the nurse is unable to collect my child’s blood?

During this study, we would like to obtain a small amount (1 teaspoon) of your child’s blood at various time points. 

Our nurses are well trained in infant and child blood draws and will make every effort to make you and your child 

comfortable during this process. If you are uncomfortable at any time, please let the nurses and study team know so we 

can discuss with you. 

Will I have results of the study? 

Once the study results have been analyzed and published, anyone will be able to find out the study results. 

Will I receive results from samples collected? 

Since the lab analyzing you and your child’s biological samples is a research lab, not a clinical lab, you will not receive 

those results. 

Can samples be picked up at a different residence sometimes? 

Yes, as long as the different address is within 20 miles of University Hospital Medical Center. It is very important that you 

make sure you tell the courier you are in the PREVAIL study and give the correct place and address for pick up. We ask 

that the samples be collected by you or someone trained by the study team member and not by someone who has not 

been instructed on how to collect the samples. 

What will happen at the Home study visits? 

When you baby is around 2 weeks old, one of the study staff will visit your home. We will ask you questions about your 

baby & delivery. We will collect your baby’s stool, a nasal swab and saliva. 

When your child has a *fever and/or cough, study staff will call to ask you about your child’s illness and may schedule a 

brief home visit to collect more information and nasal swabs. 

*Fever: A thermometer reading of greater than 100.4 under the arm or greater than 98.6 taken rectally at any time 

during the previous week 

Vomiting & diarrheal illness - 3 or more loose or watery stools and/or 1 or more vomiting episodes within 24 hours at 

any time in the previous week. 
PREVAIL FAQ’s.doc V. 1.0 

TIMEPOINT WHEN & WHERE WHAT WILL HAPPEN

ENROLLMENT

When you are at least 34 weeks 

pregnant with only one baby

Questionnaire, Maternal blood, 

saliva, and nasal swab

Birth When you deliver your baby at the 

Hospital

Cord blood 

Meconium-your baby’s first stool

Week 2 Home Visit When your baby is 10-16-days old

Review study, Questionnaire, 

Breast milk, infant saliva, stool and 

nasal swab collections

Week 6 Clinic Visit When your baby is 6 weeks old. 

At CCHMC research clinic

Questionnaire – Collection of breast 

milk and infant blood (1 teaspoon)

Month 4 Phone call When your baby is 4 months old Brief questionnaire – 5-10 minutes

Month 6 Clinic Visit When your baby is 6 months old

At CCHMC research clinic

Questionnaire and infant blood 

(1 teaspoon)

Month 9 Phone call When your baby is 9 months old Brief questionnaire – 5-10 minutes

Month 12 Clinic Visit

When your baby is one year old

At CCHMC research clinic

Questionnaire and infant blood 

(1 teaspoon)

Month 15 Phone call When your child is 15 months old Brief questionnaire – 5-10 minutes

Month 18 Clinic Visit When your child is 18 months old

At CCHMC research clinic

Questionnaire and infant blood 

(1 teaspoon)

Month 21 Phone call When your child is 21 months old Brief questionnaire – 5-10 minutes

Month 24 Clinic Visit When your child is two years old

At CCHMC research clinic

Questionnaire and infant blood 

(1 teaspoon)

Weekly sample collections Weekly – At your home Nasal swab & stool sent to CCHMC 

by courier provided by study

Weekly texts

Sent to your phone

The text will ask you to respond to the 

questions with a text

In the past week: Did your child have

fever and/or cough? Did your child 

have vomiting and/or diarrhea?

When your child has fever 

and/or cough

Your home - Study coordinator calls to 

make a home visit to follow up

Questionnaire, nasal swab collection 

of your child and children ≤11 yrs. by 

study team

When your child has vomiting 

and/or diarrhea Your home Questionnaire & additional stool sent to CCHMC by courier service

Total participation is 2 years PREVAIL Compensation could be up to $1555 

for FULL participation

Clinic Visits at CCHMC Schubert Research Clinic

Home Visits – Scheduled at two weeks AND when your child has fever and/or cough

Weekly texts and sample collections