please clarify the following 

1- mention the pre surgical preparation of the volunteer infants

2- will the surgery be preformed under local or general anesthesia? 

3- if it will be performed under general anesthesia; where will it be performed?

4- mention the possible risks, side effects and complications of the surgery and what are the management protocols to prevent their occurrence and  the management procedures if they happen

5- will the volunteer infants need any post surgical medication? if yes mention in details

6- mention in details the procedures of each visit of the volunteer infants and what will be done in details including any photos or radiology imaging.

7- mention who is responsible for the activation of the device

8- mention the responsibility of the child care giver regarding home care (also mention in simple Arabic in the informed consent) 

9- mention after the end of the research if there will be any recommendations to be delivered to the child care giver.

10 - the informed consent needs to be modified to be suitable for the research procedures mentioning in details what will be done in each visit including photos and imaging and the responsibility of the child care giver for home care of the volunteer infants