1. Infant Surface Exams: Procedures, Source Documents, Photos, and eCRFs
Study-Specific Training May 2017

2. Purpose
To establish each infant’s physical condition at the Delivery Visit (as soon as possible after birth)
To complete a systematic and standardized assessment for congenital anomalies (i.e., birth defects, congenital defects, congenital malformation)

3. What is a congenital anomaly?
Abnormalities that are present at birth:
Structural  the way the body looks (inside or outside)
Functional  the way the body performs

4. Why do congenital anomalies occur?
About half of the time, the reason is unknown
Other reasons include
Genetics
Infections, like syphilis or rubella
Nutritional deficiencies, like iodine or folate
Exposures from alcohol, smoking, or chemicals
Medications (potentially efavirenz, cotrimoxazole, fluconazole, tetracycline, enalapril?)

5. Infant Exam at Delivery Visit
This slide highlights the physical examination performed for infants at the Delivery Visit

6. Procedures
Per protocol Section 6.16, complete exams are required at the Delivery Visit
Newborn step-wise surface exam is a required part of the complete exam
This slide shows procedural text from protocol Section 6.16 related to these exams.
A “newborn step wise surface examination” is required at this visit, with the expectation that WHO standard procedures for performing these exams will be followed at all sites.
The protocol provides a web site for more information and on the next slide we have a snapshot of this website.

7. This is what the website looks like

8. And on this slide we are showing more of a close-up view of the training video available on the website. All clinicians who will be involved in performing these exams should watch this video in preparation for other study-specific training to come.

9. Procedures
All elements of the surface exam should be performed for purposes of assessing for congenital anomalies, with the exception of:
Intra-oral system
Cardiac system
Genitourinary system
These should be included in the general exam but will not be routinely assessed for presence of congenital anomalies
Consider modifying or deleting this slide?

10. Procedures Face (including mouth) Neck
Head (including fontanels & circumference)
Face (including mouth)
Neck
Chest
Physical appearance, length, weight, & skin
Spine
Hips & Genitalia
Abdomen & Anus
Arms, legs, fingers, & toes

11. Procedures Face Neck Physical appearance, length, weight, & skin Chest
Head (including fontanels & circumference)
Face
Neck
Chest
Physical appearance, length, weight, & skin
Spine
Hips & Genitalia
Abdomen & Anus
Arms, legs, fingers, & toes

12. Procedures
If any potential congenital anomalies are identified on examination of any body system, these should be photographed by the examining clinician and a site pediatrician should ideally examine the infant as soon as possible

13. Who will take photographs at your site?
Procedures
Who will take photographs at your site?

14. All exam findings should be source documented
Documentation
All exam findings should be source documented
Speaker can say that the sample source document is intended for use at the delivery visit to capture all aspects of the Complete Physical Exam required per protocol, which includes the newborn surface exam as well as other exam components (auscultation of chest, neurologic assessment).

15. Entering into the database
Any suspected congenital anomaly in any body system should be entered into eCRFs
DXW10000, IMPAACT 2010 Congenital Anomalies
ADE10002, Adverse Events Log

16. Entering into the database
We can defer detailed discussion of AE reporting to Day 3, but state that, per protocol Section 7.2.2, all suspected congenital anomalies must be reported on Adverse Event eCRFs
If anyone brings up EAE reporting, can use that as an opportunity to look protocol Section

17. Entering into the database

18. Entering into the database
DXW10000: Congenital Anomalies
Provide a detailed narrative about the anomaly
Enter the date the anomaly was first identified
Indicate the number of photographs uploaded to the File Exchange Utility (on FSTRF portal)
Emphasize to include all available descriptive information in the narrative (no issues with number of characters allowed to be entered)

19. Entering into the database
Photos will be securely uploaded to the DMC to permit review and evaluation by the CMC (including an expert on birth defects)
Descriptive data and photos will be reviewed in near real time to determine whether the abnormality meets the protocol definition of “major congenital anomaly”

20. 1. During the surface exam, the site clinician identifies polydactyly
1. During the surface exam, the site clinician identifies polydactyly. This should be source documented.
True
False

21. 1. During the surface exam, the site clinician identifies polydactyly
1. During the surface exam, the site clinician identifies polydactyly. This should be entered into eCRFs.
True
False
Should we again clarify which eCRFs?

22. 2. A suspected cardiac congenital anomaly is identified by an attending clinician in the hospital where the infant was born. This anomaly should be source documented.
True
False
I like this series of slides – let’s just check with Shahin to make sure they are right. I never really understood the wording about the “exceptions” this in protocol Section 6.16.

23. 2. A suspected cardiac congenital anomaly is identified by an attending clinician in the hospital where the infant was born. This anomaly should be entered into eCRFs.
Yes No
Maybe
Should we also specify which eCRF we are talking about? DXW10000 versus Adverse Event Log?

24. 2. A suspected cardiac congenital anomaly is identified by an attending clinician in the hospital where the infant was born. This anomaly should be entered into eCRFs.
Yes No
Maybe

26. Privacy and Confidentiality
If any photographs are taken, standard precautions will be followed to protect participant privacy and confidentiality
Photographs that may be transmitted off-site will be identified by PID only
Protocol Section 12.7

27. Privacy and Confidentiality
How will your site maintain privacy and confidentiality of infants who are photographed?
Protocol Section 12.7

28. Privacy and Confidentiality
Does your site IRB/EC mandate a separate form for obtaining informed consent for photographs?
Protocol Section 12.7

29. Privacy and Confidentiality
“If we take photos of abnormalities seen when your baby is examined, we will not photograph your baby’s face unless the abnormality is on the face. In that case, we will make every effort to hide details that could identify your baby. Photos will be labeled only with a code number (not with your or your baby’s name). Photos will be kept securely with other information collected for the study. Photos also may be shared with other doctors working on the study. The other doctors may be here at [site name] or in other countries. These doctors will not be given your or your baby’s name, and they will be required to keep the photos private and confidential. When the study is completed, the photos will be destroyed.”
From sample ICF, Item 24 “There could be risks of disclosure of your and your baby’s information”

30. What are your questions about Infant Surface Exams?