1-     Objectives should be SMART, Specific, Measurable, Achievable, Relevant and Time-related. The objectives as written do not fulfill these criteria.

“Cleft lip repair Minimizing nasal & oral defect before surgery Helping patients for better lactation, drinking & feeding. Better health and physical appearance” How will all these be measured?

2-     Procedures in Details: this section is written in the past tense, while the submission includes an informed consent. Please clarify whether this is a case series that you want to publish (cases were seen at the clinic and you have the data and want to report them), or an interventional study, as mentioned in the submission form Study Type (you will still enroll subjects after approvals).

3-     The procedures should be more detailed, e.g. who will put the device, what does it mean active, how will it put, what role has the mother or none, any interventions after the device is put, any follow ups, when and what for are the follow ups, etc.

4-     Age range of participants is written as infants age (1-4 ) months, while the inclusion criteria say 3 months. Is it 3 or 4?

5-     In the risks section, the investigators say no risk (Risks / side effects to the participants), while in the criteria for discontinuation it is mentioned “Any allergic complications Any difficulty in breathing”. These are potential side effects and should be mentioned as risks and the investigator should also mention what procedures will be done to prevent and minimize these side effects and how will these side effects be dealt with.

6-     Provisions for dealing with complications: “Stop wearing active screw nam device”: Will these cases be excluded from the study?

7-     What are the outcomes and the endpoints of the study?

8-     Who will pay for the device?

9-     Confidentiality: “Limiting access to information”: how do the investigators plan to do this?

Consent

1-     Informed consent should be better formatted to be easier for the parents to read and comprehend, e.g. Instructions and extra sentences should be deleted, the document should be all in the same font, etc.

2-     This informed consent should be addressed to the parents not the infant.

3-     Please mention the alternatives, not just write “ask the investigator”

4-     تجربة إكلينيكية منضبطة this is not a controlled trial as it has only one arm

5-     This is not true for this study التجربة التالية بشكل عشوائي:

1. الذراع الأول

2. الذراع الثاني

6-     سوف يطلب منك الرجوع إلى عيادة الطبيب المشرف على الدراسة أو المستشفى لمتابعة الفحوصات

How many time will they be required to come back

7-     Mention in the consent whether they will pay for the device or not