0920-0950 Blood - Infants Questionnaire

Attachment 1b

National Health and Nutrition Examination Survey (NHANES)

Blood Draw – Infants (0 to less than 12 months) Pilot Study

Form Approved

OMB No. 0920-0950

Assurance of Confidentiality - We take your privacy very seriously. All information that relates to or describes identifiable characteristics of individuals, a practice, or an establishment will be used only for statistical purposes. NCHS staff, contractors, and agents will not disclose or release responses in identifiable form without the consent of the individual or establishment in accordance with section 308(d) of the Public Health Service Act (42 U.S.C. 242m(d)) and the Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA, Title 5 of Public Law 107-347). In accordance with CIPSEA, every NCHS employee, contractor, and agent has taken an oath and is subject to a jail term of up to five years, a fine of up to $250,000, or both if he or she willfully discloses ANY identifiable information about you

Public reporting burden of this collection of information is estimated to average 15 minutes per response, including the time for reviewing instructions, searching existing data/information sources, gathering and maintaining the data/information 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 CDC/ATSDR Information Collection review Office, 1600 Clifton Road NE, MS D-74, Atlanta, GA 30333. ATTN: PRA (0920-0950).

Exp. Date: 11/30/2021

This attachment represents the burden for the blood draws for participants 0 to less than 12 months and/or the time to complete the venipuncture refusal questionnaire.

Safety Exclusion and Fasting Questionnaire

Question 1: Does your infant have a bleeding disorder such as hemophilia or von Willebrand Disease, or a blood disorder such as aplastic anemia or leukemia?

Record the response by typing [Y] for “Yes,” [N] for “No,” [R] if he or she refuses, or [D] for “Don’t know.”

Q1: This question asks whether the SP (Survey Participant) has a bleeding disorder such as hemophilia or a blood disorder such as aplastic anemia or leukemia, which is an exclusion criterion for this procedure.

Explain to parent or guardian that we cannot perform phlebotomy on participants who have hemophilia or a known blood disorder. Hemophilia is a rare disease where an individual’s blood does not clot normally. If a relative has hemophilia or a blood disorder but the infant does not, the infant is not excluded. If the infant is excluded, the Blood Draw Exclusion box displays. Read the text in the box to the parent or guardian and escort the infant and parent/guardian SP back to the coordinator area.

Question 2: Is your infant currently participating in a chemotherapy protocol or received cancer chemotherapy in the past 4 weeks? Record the response by typing Y for “Yes, N for “No,” R if he or she refuses, or D for “Don’t know.”

Q2: This question asks whether the SP is currently receiving cancer chemotherapy or received cancer chemotherapy in the past 4 weeks. This situation excludes the SP from this procedure.

Explain that we cannot perform phlebotomy on participants who are currently receiving cancer chemotherapy or have received cancer chemotherapy within the past 4 weeks. If the infant is excluded, the Blood Draw Exclusion box is displayed. Read the text in the box to the parent or guardian and escort parent/guardian and infant back to the coordinator area.

Question 3: Has your infant had blood drawn in the past 30 days? Record the response by typing Y for “Yes, N for “No,” R if he or she refuses, or D for “Don’t know.”

Q2: This question asks whether the SP has had blood drawn in the past 30 days. This situation excludes the SP from this procedure.

Explain that we cannot perform phlebotomy on participants who have had recent blood draws. If the infant is excluded, the Blood Draw Exclusion box is displayed. Read the text in the box to the parent or guardian and escort parent/guardian and infant back to the coordinator area.

Fasting Questionnaire

Q1: When was the last time your infant ate or drank anything other than plain water? Record date and time of response

Q1: This question elicits the last time the SP ate or drank anything and determines fasting time.

Record the last time the infant has had anything to eat or drink.

Q2: Has your infant had any of the following since (time from question 1 inserted here)? Record date and time of response

Milk, juice or soda	Do not include diet soda.
Cough or cold remedies?	Ask the SP to describe the activity, item consumed, and the correct time.
Antacids, laxatives, or anti-diarrheal medications?	Antacids neutralize stomach acids. Laxatives stimulate evacuation of the bowels. Anti-diarrheals relieve diarrhea and cramping. Include all over-the-counter antacids, laxatives, and anti-diarrheals. If the answer is “Yes,” clarify the response. Ask the SP to describe the activity, item consumed, and the correct time.
Dietary supplements such as vitamins? [Include multivitamins and single nutrient supplements.]	Vitamins refer to various relatively complex organic substances occurring naturally in plant and animal tissue. They are essential in small amounts for the control of metabolic processes. Many are available over the counter as liquid multivitamins or single-nutrient supplements like Vitamin D. Include all of these when clarifying the response to this question. If the answer is “Yes,” clarify the response. Ask the SP to describe the supplement, item consumed, and the correct time.

Blood Draw Exclusion Box – Example Text

The following responses will be read to the participant if they answer “yes”, refused or don’t know to the safety exclusion questions in the infant blood pilot.

Blood drawn in 30 days:

(Yes): Because your infant has had blood collected in the past 30 days, we will not be able to draw blood for this study. However, I would like to thank you very much for answering my questions and for cooperating with our research.

(Ref): Because you refused to answer if your infant has had blood collected in the past 30 days, we will not be able to draw blood for this study. However, I would like to thank you very much for answering my questions and for cooperating with our research.

(DK): Because you do not know if your infant has had blood collected in the past 30 days, we will not be able to draw blood for this study. However, I would like to thank you very much for answering my questions and for cooperating with our research.

  

Hemophilia:

(Yes): Because your infant has hemophilia or other blood disorder, we will not be able to draw blood for this study. However, I would like to thank you very much for answering my questions and for cooperating with our research.

(Ref): Because you refused to answer if your infant has hemophilia or other blood disorder, we will not be able to draw blood for this study. However, I would like to thank you very much for answering my questions and for cooperating with our research.

(DK): Because you do not know if your infant has hemophilia or other blood disorder, we will not be able to draw blood for this study. However, I would like to thank you very much for answering my questions and for cooperating with our research.

 

Chemotherapy:

(Yes): Because your infant had recent chemotherapy or is currently undergoing chemotherapy, we will not be able to draw blood for this study. However, I would like to thank you very much for answering my questions and for cooperating with our research.

(Ref): Because you refused to answer if your infant had recent chemotherapy or is currently undergoing chemotherapy, we will not be able to draw blood for this study. However, I would like to thank you very much for answering my questions and for cooperating with our research.

(DK): Because you do not know if your infant had recent chemotherapy or is currently undergoing chemotherapy, we will not be able to draw blood for this study. However, I would like to thank you very much for answering my questions and for cooperating with our research.

Follow-Up Questionnaire for Venipuncture Refusal

NHANES recommends administering a follow-up questionnaire to the parents/guardians that have refused the venipuncture to gain insight about the reasons for refusal.

It is common for parents to not permit a blood draw on their newborn or infant. To help us better understand why parents may decide not to allow us to draw blood on their infant, we appreciate if you could answer the following one question.

1. What is the reason you chose not to have your infant’s blood drawn today? Please check all that apply.

____Baby is too young

____Do not want to hurt the baby or fear of sticking child/hurting child

____Fear of child crying

____Too much blood

____It is not important enough to justify the pain

____Afraid of complications if the baby moves

____Afraid of multiple attempts for a successful blood draw

____Other specify (add parent or guardian’s reason) ____________________________________

2. Is there anything that would have changed your mind?

3. Is there anything the staff could have done to make you feel more comfortable?

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