1 Survery

Appendix A A.2.3.j–7

OMB #: 0925-xxxx

Expiration Date: xx/xxxx

National Children’s Study

Child Saliva Collection Instructions

We are giving you one (1) storage box, four (4) labelled plastic tubes and four (4) envelopes each containing two (2) cotton swabs to collect your child’s saliva samples. Two of the tubes are marked Day 1 Wake, and Day 1 Night. The other two tubes are marked with Day 2 Wake, and Day 2 Night.

You should collect the saliva samples from your child on two consecutive days.

You should collect the first saliva sample of each day from your child as soon as he/she wakes up—Wake sample. The second saliva sample of each day should be collected before the child goes to bed and at least 1 hour after eating but before brushing his/her teeth—Night sample.

IMPORTANT NOTES

• It is essential that you record the time that you collect the samples.

• You should not let the child lie in bed awake before you begin. Take the first sample as soon as the child wakes up for the day!

• Do not feed your child or brush his or her teeth within 1 hour prior to sample collection

• If you typically give your child a bottle just prior to putting him/her down for the night, please collect the sample before you give him/her the bottle. If your child ate food within 1 hour before bed, you should rinse his or her mouth with water before collecting the saliva sample. Please wait 10 minutes after your rinse your child’s mouth with water, then collect the Night sample.

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Here’s how to collect the saliva samples:

1. Remove the cap from the tube marked “Wake Day 1.”

2. Place the cap upside down on a flat surface.

3. Remove one swab from the envelope. Close the envelope immediately to protect the remaining swabs.

4. Place the swab under the child’s tongue and hold it there for 15 to 30 seconds then move it around inside that child’s mouth so that it collects any saliva that may have pooled. Be sure to keep the swab inside the child’s mouth for 1 minute.

5. Insert the swab tip down into the cap.

6. Immediately repeat steps 3 through 5 to collect the second swab for “Wake Day 1”.

7. Once both swabs have been inserted in the cap, slide the plastic tube over the purple sticks and snap down securely into the cap.

8. Place the tube in the storage box and put the box in the freezer.

9. Write the time that the sample was collected on the Day 1 Child Saliva Data Collection Form.

10. Repeat steps 1–9 for the Day 1 Night sample. Tomorrow repeat steps 1–10 for the Day 2 Wake and the Day 2 Night samples and complete the Day 2 Child Saliva Data Collection Form.

Feel free to call if you have any questions.

[Name and phone numbers]

For Office Use Only

Participant # __ __ __ __ __

#__ __ __ __

National Children’s Study

DAY 1: CHILD SALIVA DATA COLLECTION FORM

**Please collect your child’s saliva sample on the 2 days following our visit to your home on __________. Please write down the exact time that you collected each saliva sample in the spaces below.

Day 1 saliva samples

What is the date you collected the Day 1 saliva samples _____/______/______

Month Day Year

Tube #	When to take sample	Time collected	For Office Use Only
Wake	As soon as the child wakes up	_____:_____
Bedtime	Before brushing his/her teeth and at least 1 hour after eating for the last time today	_____:_____

1. Please write down the name of any prescription or over the counter medications that your child has taken today. Please be specific. For example, if he/she took Robitussin DM^®, write Robitussin DM^® not Robitussin^®.

__________________________ ___________________

__________________________ ___________________

__________________________ ___________________

Please feel free to call if you have any questions:

[X at phone #]

For Office Use Only

Participant # __ __ __ __ __

#__ __ __ __ __

National Children’s Study

DAY 2: CHILD SALIVA DATA COLLECTION FORM

**Please collect your child’s saliva sample on the 2 days following our visit to your home on __________. Please write down the exact time that you collected each saliva sample in the spaces below.

Day 2 saliva samples

What is the date you collected the Day 2 saliva samples _____/______/______

Month Day Year

Tube #	When to take sample	Time collected	For Office Use Only
Wake	As soon as the child wakes up	_____:_____
Night	Before brushing his/her teeth and at least 1 hour after eating for the last time today	_____:_____

2. Please write down the name of any prescription or over the counter medications that your child has taken today. Please be specific. For example, if he/she took Robitussin DM^®, write Robitussin DM^® not Robitussin^®.

__________________________ ___________________

__________________________ ___________________

__________________________ ___________________

Please feel free to call if you have any questions:

[X at phone #]

Public reporting burden for this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-xxxx*). Do not return the completed form to this address.