B.1.5 LOI3-BIO-05 Exemplar Collection Instructions

ATTACHMENT B.1.5 Collection Instructions
LOI3-BIO-05 & LOI3-BIO-05

OMB #: 0925-0593
EXPIRATION DATE: 07/31/2013

Breast Milk Collection Instructions
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As part of this methods study, we are asking you to collect a sample of your breast milk. We are
asking you to provide about 3 ounces of breast milk (about 6 tablespoons).
This kit includes everything you will need to collect the sample:
•
2 absorbent cloths
•
1 Plastic collection container, prelabeled
•
1 Plastic amber bag with absorbent pad
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Important instructions before getting started
Please collect this sample as close to the time of your pick up visit as possible.
•

For this sample collection, you are asked to collect breast milk from one breast only, and
to completely drain the breast. You may not have enough milk left after the collection to
satisfy your baby. For this reason, please make sure to pump milk ahead of time so that
you have enough milk to feed your baby after the sample is taken.

•

Please do not breast-feed your baby or pump breast milk from the breast you will use to
provide this sample for 2 hours prior to the sample collection. Please do not eat food or
take medication for 2 hours prior to the sample collection.

•

Please collect the breast milk sample sometime in the morning, preferably between 9:00
a.m. – 12:00 p.m. (noon). You will be asked to write down the time you collected the
sample on the Breast Milk Data Collection Form.

•

Please use your own breast pump to collect this sample. If you choose, you may also
squeeze out the breast milk by hand in order to collect this sample.

•

Please do not use any soaps, cleansers, lotions, or creams on the breast or nipple prior to
the sample collection.

•
Be sure to drink plenty of water before and after the sample collection.
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Collection Instructions
1. Thoroughly wash your hands with soap and water and dry with a clean towel.
2. Wash one breast and nipple with warm tap water only, using one of the two absorbent cloths
provided. Please do not use any soap or other cleanser to clean the area, and do not apply any lotion
or cream. Gently dry the area with the second absorbent cloth.
3. Follow the manufacturer’s instructions for your breast pump in order to safely collect the sample.
4. If you choose to squeeze out the breast milk by hand, you can either collect the milk directly in the
plastic container provided or in your own collection container.
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Immediately after collection
1. Gently mix the milk in the container you used to collect the sample by swirling the container. This is
important in order to thoroughly mix the different components of the breast milk.
2. Remove the lid from the prelabeled plastic container provided in the Breast Milk Collection Kit. After
you have gently mixed the sample, pour the milk into the container so that the total volume in the
container is approximately to the 80 mL mark on the container. If you did not collect enough milk to
fill the container to the 80 mL mark, pour whatever you have collected into the container. Place the
lid on the container.
3. If there is any milk left over in the container you used to collect the sample, you can save it for your
baby.
4. Place the prelabeled plastic container into the plastic amber bag with the absorbent pad, seal the
bag, and place it in the freezer until it can be picked up by the Study staff. Please keep the labels
that came with the kit inside the bag.
5. Complete the Breast Milk Data Collection Form.
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Please call the Study Center phone number on your Local Contact Sheet if you have any questions.
Thank you for providing this sample!

Public reporting burden for this collection of information is estimated to average 30 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 (0925-0593). Do not return
the completed form to this address.

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