1 Survey

Recruitment Strategy Substudy for the National Children's Study (NICHD)

A.2.3.l 6-Blood Draw Data Collection Form 12 months Child

Postnatal Activities - Mother and Children

OMB: 0925-0593

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Appendix A A.2.3.l–22

For Office Use Only

Participant # __ __ __ __ __


#__ __ __ __ __



National Children’s Study

Child 12 Months Blood Draw Data Collection Form


Part A: Administrative

Date: |__|__| / |__|__| / |__|2___0_|__|__|



Section Status (Select one) Complete 1

Partial Complete 2

Not Done 3


Reason for Not Done/Partial (Select one)

Safety Exclusion 1

Physical Limitations 2

Participant III/Emergency 3

Equipment Failure 4

Communication Problem 5

No Time 6

Other Specify___________________ 96

Refused 97

Don’t Know 98


Assignment ID: |___|___|___|___|___|___|


Participant ID: |___|___|___|___|___|___|


Data Collector ID: |___|___|___|___|


Site ID: |___|___|___|___|


Participant’s age |__|__| months



Part B: Blood Collection Questions (Ask these questions at all visits when blood is drawn for the child.)

1) Does _____ (child’s name) have hemophilia or any bleeding disorder?

1 Yes (Go to Part C) 2 No

97 Refuse 98 Don’t Know


2) Does _____ (child’s name) take any blood-thinning medication, such as Coumadin or Warfarin?

1 Yes (Go to Part C) 2 No

97 Refuse 98 Don’t Know


3) Has _____ (child’s name) had cancer chemotherapy within the past 4 weeks?

1 Yes (Go to Part C) 2 No

97 Refuse 98 Don’t Know


4) Has _____ (child’s name) had any problems with a blood draw in the past?

1 Yes 2 No (Go to Q 6)

97 Refuse (Go to Q 6) 98 Don’t Know ( Go to Q 6)


5). What problems did _____ (child’s name) have with a blood draw in the past? (Check all that apply)

Fainting 1

Light-Headedness 2

Hematoma 3

Bruising 4

Other Specify___________________ 96

Refused 97

Don’t Know 97


6) When was the last time _____ (child’s name) had anything to eat or drink?

|__|__|:|__|__| 1 am 2 pm

7) Is this a fasting blood sample? (If the answer to Question 6 is less than 8 hours ago the answer is No.)


1 Yes 2 No


Part C Saliva Collection (Only use if blood collection is refused or not possible)

8) Because your child {has hemophilia; is taking blood thinning medication; has had chemotherapy recently} we will not be able to draw his/her blood at this time. Several measures that are performed in blood can be measured in saliva. Is _____ (child’s name) able to provide a saliva sample? 1Yes 2 No

BE SURE TO REVIEW SALIVA SAMPLE COLLECTION INSTRUCTIONS WITH THE PARTICIPANT

Kit ID: |___|___|___|___|___|___|___|___|___|___|___|___|

9) Saliva collection status 1 Collected 2 Not Collected

Reason for not collecting

No Time 1

Participant III/Emergency 2

Equipment Failure 3

Other Specify___________________ 96

Refused 97

Don’t Know 98

Could Not Obtain 99

Saliva Comments:

________________________________________________________________________________________



________________________________________________________________________________________



________________________________________________________________________________________



________________________________________________________________________________________




Part D Tubes to be drawn for Child at 12 Months

Kit ID: |___|___|___|___|___|___|___|___|___|___|___|___|

Red top (5ml)

1 Collected 2 Not Collected

Reason for not collecting:

No Time 1

Participant Ill/Emergency 2

Equipment Failure 3

Fainting 4

Light-Headedness 5

Hematoma 6

Bruising 7

Vein Collapsed During the Procedure 8

No Suitable Vein 9

Other, Specify_________ 96

Refuse 97

Don’t Know 98

Tube barcode

|___|___|___|___|___|___|___|___|___|___|___|___|

Red top (5ml)

1 Collected 2 Not Collected

Reason for not collecting:

No Time 1

Participant Ill/Emergency 2

Equipment Failure 3

Fainting 4

Light-Headedness 5

Hematoma 6

Bruising 7

Vein Collapsed During the Procedure 8

No Suitable Vein 9

Other, Specify_________ 96

Refuse 97

Don’t Know 98

Tube barcode

|___|___|___|___|___|___|___|___|___|___|___|___|

Lavender top (6ml)

1 Collected 2 Not Collected

Reason for not collecting:

No Time 1

Participant Ill/Emergency 2

Equipment Failure 3

Fainting 4

Light-Headedness 5

Hematoma 6

Bruising 7

Vein Collapsed During the Procedure 8

No Suitable Vein 9

Other, Specify_________ 96

Refuse 97

Don’t Know 98

Tube barcode

|___|___|___|___|___|___|___|___|___|___|___|___|

Pre-screened lavender top (3ml)

1 Collected 2 Not Collected

Reason for not collecting:

No Time 1

Participant Ill/Emergency 2

Equipment Failure 3

Fainting 4

Light-Headedness 5

Hematoma 6

Bruising 7

Vein Collapsed During the Procedure 8

No Suitable Vein 9

Other, Specify_________ 96

Refuse 97

Don’t Know 98

Tube barcode

|___|___|___|___|___|___|___|___|___|___|___|___|

Blood Collection Comment:________________________________________________________

________________________________________________________________________________

________________________________________________________________________________

________________________________________________________________________________


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