Form 0920-0879 PEDIATRIC HEPATITIS OF UNKNOWN ETIOLOGY MEDICAL RECORD A

Attachment A: PEDIATRIC HEPATITIS OF UNKNOWN ETIOLOGY MEDICAL RECORD ABSTRACTION FORM: CONTROLS

Control ID: _________________________________ MATCHED CASE ID:__________________________

Form Approved: OMB No. # 0920-0879 Exp. Date 08/31/2026

Version 19 Aug 2022

General Instructions:

• Please complete the form for all children who are enrolled as controls in the case-control evaluation to examine the potential causes of pediatric hepatitis of unknown etiology.

• Yellow fields do not need to be submitted to CDC.

• Greyed out fields do not require information.

• ControlID: Please assign using the caseID followed by a dash and two numbers (ie. ‘-01-04’). For example, if the caseID = ‘GA0001’ the control ID would be GA0001-01 for the first enrolled control and so on for each additional control enrolled (up to a maximum of 4 controls per case).

• Some sections may be best completed by a clinician (e.g. Clinical Info)

• Vaccination information should be captured from the state Immunization Information System as the primary source.

• Any relevant information that does not fit in a designated section can be noted in the “Notes” section.

• All dates should be in the format MM/DD/YYYY.

Reminder about adenovirus testing:

• CDC is requesting residual/available respiratory, stool, and blood (including whole blood, plasma or serum) specimens be sent to CDC for testing and (if adenovirus positive) typing.

• Please refer to the specimen protocol for additional instructions on testing/shipping of specimens.

Submission Instructions:

CDC requests submission of completed forms on a rolling basis. Please upload completed forms to the ShareFile folder via one of the following:

1. Scanned/electronic copy of the completed form

2. CSV export from REDCap database (if using CDC REDCap data structure in state/local REDCap instance)

For questions related to form completion or submission instructions, email [email protected]

Date form completed: ____/____/_______
DEMOGRAPHICS Yellow fields do not need to be submitted to CDC
Patient’s name (Last, First, M.I.) ______________________________________			DOB: ____/____/_______
Age: □ Days □ Months □ Years		Sex assigned at birth: □ Male □ Female □ Refused □ Don’t know
Street Address:
City: County: State: Zip: _____________
Phone (Cell/Home): _________________________		Phone (Cell/Home): _________________________
Ethnicity: □ Hispanic or Latino □ Not Hispanic or Latino □ Unknown	Race □ American Indian/Alaska Native □ Native Hawaiian/Pacific Islander (check all that apply) □ Asian □ White □ Black/African American □ Other (________________)

SIGNS/SYMPTOM HISTORY
Did the patient have any of the following signs/symptoms in the past 2 weeks?
Category of signs/symptoms	Check all that apply:
First Respiratory sign/symptom Onset: ____/_____/____ □ Unknown	□ Cough □ Congestion □ Rhinorrhea □ Sore throat □ Wheezing □ Shortness of breath □ Conjunctivitis (pink eye)
First GI sign/symptom Onset: _____/_____/______ □ Unknown	□ Diarrhea □ Nausea □ Vomiting □ Abdominal Pain
Date of systemic sign/symptom Onset: _____/_____/______ □ Unknown	□ Fatigue □ Fever (Max) ________ °F □ Decreased appetite □ Other, specify:

CLINICAL INFORMATION

Yellow fields do not need to be submitted to CDC.

For date of initial evaluations, please note the date that the child first sought medical care for this illness.

Patient Height: __________ □ ft/in □ cm □ Unknown

Patient Weight: ___________ □ Ibs □ Kg □ Unknown

Reason patient was receiving medical care:

□ Tonsillectomy

□ Ear tubes (Tympanostomy)

□ Illness of infectious etiology, specify

_____________________

□ Other surgical procedure, specify ____________________

□ Chronic illness, specify ____________________

□ Injury, specify___________________________

□ Other, specify ___________________________

Date of evaluation: _____/_____/______ □ Unknown

Where was the patient first identified?

□ Primary care provider

□ Urgent care

□ Emergency department

□ Hospital

□ Unknown

□ Other, specify ______________

Name of facility:

________________________

Was the patient hospitalized for this illness? □ Yes □ No □ Unknown

If patient was hospitalized: Hospital: __________________________ Medical Record #: _________

Admission Date (Initial Hospital):____/____/_______ □ Unknown admission date

Was the patient transferred from another hospital? □ Yes □ No □ Unknown

If yes, which hospital? _________________________ Transfer Date: ___/___/______ □ Unknown

Final patient outcome: □ Survived, discharge home

□ Survived, discharged other location

□ Died If yes, was an autopsy performed? □ Yes □ No □ Unknown

□ Unknown

Date of discharge / death: _____/_____/_______ □ Unknown date of discharge/death

If patient was hospitalized: ICD-10 discharge codes:

Primary code: Other codes (list up to 10):

Were there additional codes beyond those listed above: □ Yes □ No □ Unknown

UNDERLYING HEALTH CONDITIONS
Did the patient have any of the following underlying health conditions? □ Yes □ No □ Unknown
If yes, check all that apply: □ Asthma (or Reactive Airway Disease) □ Congenital Heart Disease □ Diabetes Mellitus (Type 1 or 2) □ Leukemia/Lymphoma □ Sickle cell anemia □ Seizure/Seizure disorder	□ Other cancer, specify___________________________________ □ Developmental disorder, specify__________________________ □ Premature Birth (Gestational age at birth: ___________ weeks) □ History of any transplant, specify _________________________ □ Other condition, specify ________________________________

ADENOVIRUS TESTING Provide information on any repeat testing or multiple sample types in the ‘Other sample, specify’ fields and write-in the specimen type.
Diagnostic Test	Tested/Result		Specimen Collection Date (mm/dd/yyyy)		Is specimen available for shipping to CDC?
Stool	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn If tested, specify type: □ Multipanel PCR □ Other PCR □ Antigen				□ Yes □ No □ Unkn
Respiratory or throat	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn If tested, specify type: □ Multipanel PCR □ Other PCR □ Antigen				□ Yes □ No □ Unkn
Whole blood	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn				□ Yes □ No □ Unkn
Plasma	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn				□ Yes □ No □ Unkn
Serum	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn				□ Yes □ No □ Unkn
Other sample, specify ___________________	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn				□ Yes □ No □ Unkn
Other sample, specify ___________________	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn				□ Yes □ No □ Unkn
Other sample, specify ___________________	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn				□ Yes □ No □ Unkn
Diagnostic test	Value and units	Specimen Collection Date (mm/dd/yyyy)		Specimen type
Blood qPCR	_________ □ copies/mL □ IU/mL			□ Whole blood □ Plasma □ Serum
	_________ □ copies/mL □ IU/mL			□ Whole blood □ Plasma □ Serum
	_________ □ copies/mL □ IU/mL			□ Whole blood □ Plasma □ Serum
	_________ □ copies/mL □ IU/mL			□ Whole blood □ Plasma □ Serum
	_________ □ copies/mL □ IU/mL			□ Whole blood □ Plasma □ Serum
Adenovirus typing results	☐ Not Sent (not typed) ☐ Type 41 ☐ Could not be typed ☐ Other type, specify_________ ☐ Pending

GASTROINTESTINAL TESTING Greyed out fields do not require information. If multiple stool samples were collected/tested, mark pathogens detected on any specimen and provide details in the “Summary of Clinical Assessment” section.
Was a stool specimen collected for testing?			□ Yes □ No, skip to next section □ Unknown			Date of first specimen collection _____/_____/______
Gastrointestinal panel testing
Test Performed	Test Type	Pathogens Detected (check all that apply)
□ Yes □ No □ Unknown	□ Luminex xTAG □ Biofire / FilmArray □ Other: ________________ □ Unknown	□ No pathogens detected □ Campylobacter □ Clostridium difficile □ Plesiomonas shigelloides □ Salmonella □ Yersinia enterocolitica		□ Vibrio □ Vibrio cholerae □ Enteroaggregative E. coli (EAEC) □ Enteropathogenic E. coli (EPEC) □ Enterotoxigenic E. coli (ETEC) lt/st □ Shiga-like toxin-producing E. coli (STEC) □ E. coli O157 □ Shigella/Enteroinvasive E. coli (EIEC)			□ Cryptosporidium □ Cyclospora cayetanensis □ Entamoeba histolytica □ Giardia lamblia □ Astrovirus □ Norovirus GI/GII □ Rotavirus A □ Sapovirus (I, II, IV and V)
Non-panel tests
Pathogen	Tested/Result				Test Type		Details
Bacterial culture	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn						If positive, pathogen:
Norovirus	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn				□ PCR □ Other:		□ GI □GII □ Not specified
Sapovirus	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn				□ PCR □ Other:		□ I □ II □ III □ IV □ Not specified
Astrovirus	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn				□ PCR □ Other:		□ Type: □ Not specified
Rotavirus	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn				□ PCR □ EIA □ Other: _________		□ Genotype: □ Not specified
Ova & Parasite	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn						If positive, pathogen isolated: _____________
C. difficile	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn				Name of test: _____________

RESPIRATORY TESTING Greyed out fields do not require information
Was a respiratory specimen collected for testing?			□ Yes □ No □ Unknown If yes, specify specimen type ___________________			Date of specimen collection _____/_____/______
Respiratory panel testing
Test Performed	Test Type			Pathogens Detected (check all that apply)
□ Yes □ No □ Unknown	□ Luminex NxTAG RPP □ Luminex NxTAG RPP + SARS-CoV-2 □ Luminex VERIGENE RP Flex □ Biofire / FilmArray RPP □ Biofire / FilmArray PN □ Other: ___________________ □ Unknown			□ No pathogens detected □ Coronavirus HKU1 □ Coronavirus NL63 □ Coronavirus 229E □ Coronavirus OC43 □ SARS-CoV-2	□ Human Metapneumovirus □ Human Rhinovirus/Enterovirus □ Influenza A □ Influenza A/H1 □ Influenza A/H3 □ Influenza A/H1-2009 □ Influenza B □ Respiratory Syncytial Virus		□ Parainfluenza Virus 1 □ Parainfluenza Virus 2 □ Parainfluenza Virus 3 □ Parainfluenza Virus 4 □ Bordetella parapertussis □ Bordetella pertussis □ Chlamydia pneumoniae □ Mycoplasma pneumoniae □ Other :
Other respiratory specimen tests conducted
Pathogen		Tested/Result				Details		Date (mm/dd/yyyy)
SARS-CoV-2 PCR		□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn
SARS-CoV-2 Antigen		□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn
SARS-CoV-2, Serology (anti-nucleocapsid)		□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn
SARS-CoV-2, Serology (anti-spike)		□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn
SARS-CoV-2, Other specify______________		□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn
Other test (specify): ____________________		□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn				If positive, pathogen isolated:
Other test (specify): ____________________		□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn				If positive, pathogen isolated:

OTHER VIRAL TESTING
Pathogen / Test Type	Tested/Result	Test/Specimen Type	Date (mm/dd/yyyy)
Cytomegalovirus- PCR	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn	□ Whole blood PCR □ Plasma PCR
Epstein-Barr virus (EBV)- PCR	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn	□ Whole blood PCR □ Plasma PCR
EBV- Viral Capsid Antigen IgG	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn
EBV- Viral Capsid Antigen IgM	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn
EBV- Nuclear Antigen (EBNA) IgG	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn
EBV- Early antigen (EA) IgG	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn
Human herpesvirus 6	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn	□ PCR □ Other:
Human herpesvirus 7	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn	□ PCR □ Other:
Varicella-zoster virus	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn	□ PCR □ Other:
Enterovirus	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn	□ PCR □ Other:
Human immunodeficiency virus	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn	□ PCR □ Other:
Parvovirus B19	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn	□ PCR □ Other:
Herpes simplex virus-1	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn	□ PCR □ Other:
Herpes simplex virus-2	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn	□ PCR □ Other:
Measles	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn	□ PCR □ Other:
Leptospirosis	□ Not tested □ Pos □ Neg □ Indeterm □ Pending □ Unkn	□ PCR □ Other:

	PATIENT HISTORY OF COVID-19 List the most recent positive test. Any additional positive tests can be noted in the “Summary of clinical assessment” section.
	Has this patient previously tested positive for SARS-CoV-2? (before current illness)
Positive test		Test Type	Date (most recent, mm/dd/yyyy)
□ Yes □ No □ Unknown		□ PCR □ Antigen □ Serology □ Unknown	□ Date Unknown

LABORATORY MARKERS Greyed out fields do not require information
Test Name	Initial Value	Date (mm/dd/yyyy)	Highest Value	Date (mm/dd/yyyy)
Alanine aminotransferase (ALT, U/L)
Aspartate aminotransferase (AST, U/L)
Total bilirubin (mg/dL)
Conjugated bilirubin (mg/dL)
Unconjugated bilirubin (mg/dL)
INR (International Normalized Ratio)
Alkaline phosphatase (ALP, U/L)
Ammonia (µg/dL)
Prothrombin time (PT)
White blood cell (WBC) count (Cells x 109/L)
Total Lymphocyte Count (Cells x 103/µL)
Absolute Neutrophil Count (Cells x 103/µL)
Hemoglobin (HGB, g/dL)
Platelets (Plt, Cells x 109/L)
Sodium (Na, mEq/L)
Chloride (Cl, mmol/L)
Potassium (K, mEq/L)
Carbon dioxide (C02, mmol/L)
Blood urea nitrogen (BUN, mg/dL)
Creatinine (mg/dL)
Glucose (mg/dL)
Calcium (mg/dL)
Albumin (g/dL)
Uric acid (UA, mg/dL)
Fibrinogen
C-reactive protein (CRP, mg/dL)
Erythrocyte Sedimentation Rate (ESR, mm/hr)
Antinuclear antibody (ANA)
Smooth muscle antibody (ASMA)
Liver kidney microsomal antibody (LKM)
Immunoglobulin (IgG)

	VACCINATION INFORMATION Information on vaccinations received should be captured from the state Immunization Information System as the primary source. For SARS-CoV-2 vaccination, please indicate the vaccine manufacturer for each dose. Greyed out fields do not require information.
	Vaccination	Date Dose 1 (mm/dd/yyyy)	Date Dose 2 (mm/dd/yyyy)	Date Dose 3 (mm/dd/yyyy)	Date Dose 4 (mm/dd/yyyy)	Date Dose 5 (mm/dd/yyyy)
Hepatitis B
	Rotavirus
DTaP/Tdap
Hib
PCV13
IPV
MMR
Varicella
Hepatitis A
SARS-CoV-2 (add vaccine manufacturer below date)		Manufacturer:	Manufacturer:	Manufacturer:
Influenza*
Additional vaccines / doses (list vaccine & date)

*past year only

NOTES

Use this section to document any other relevant info or notes

1

CDC estimates the average public reporting burden for this collection of information as 45 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 burden to CDC/ATSDR Information Collection Review Office, 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-0879).