(A) Informed consent form

(1) Title of Research - Prediction scoring for early diagnosis of late

onset neonatal sepsis

(2) Principal investigator - Dr. Aye Thuzar Kyaw

Specialist Assistant Surgeon (Pediatric)
NICU, CWH, Yangon

(3) Introduction
I am Dr. Aye Thuzar Kyaw and I work in NICU, CWH, Yangon. As you are
aware, we are conducting a study on ‘Prediction scoring for early diagnosis of late
onset neonatal sepsis’ which you are already participating in , and as part of this we
would like to do history taking, physical examination, some blood test in our research.
This consent form will provide you with some information about the study. Please do
not hesitate to ask me to explain any words or information that you do not clearly
understand. We will also give you a signed copy (or unsigned, if you wish) to keep for
your records.

(4) Purpose of the study

The main purpose of this study is to identify predictors for early diagnosis of
late onset neonatal sepsis. We can give effective and necessary treatment in time by
getting early diagnosis. This can also present severe complication and avoid
unnecessary use of antibiotics.

(5) Type of research intervention

Hospital based analytical study

(6) Subject recruitment and selection of the study

This study will be carried out on newborn infants more than 48 hours old with
clinically suspected sepsis in NICU, CWH.
(7) Procedures
Newborn infants with clinically suspected sepsis will be recorded according to
protocol. History taking, physical examination and some blood tests will be done.
Blood samples will be collected under clean and aseptic condition before giving
antibiotics. 3 ml of blood (about ¾ of teaspoon) will be collected with disposable
syringe and needle from vein in upper and lower limbs.

(8) Duration for participation of research

It will take about 30 mins to take history, physical examination and
investigation. But it will take about 5 days to get some result such as Blood C&S.

(9) Side effects/ Risks/ discomforts

Apart from a little discomfort and pain during blood test, there will be no major
risks. The amount of blood sample to be taken will not affect the health of your baby.
And also, these are parts of routine management of newborn infants with clinically
suspected sepsis. So, participating in this research will not cause any harm to your
baby.

(10) Potential benefits of the study

The information from the study will be very useful for early diagnosis of late
onset neonatal sepsis and will also be very helpful in treating these patients.

(11) Incentives
The voluntary act of the participants will be recognized and appreciated
although there will be no financial rewards, benefits or incentives for participation in
this research.
(12) Confidentiality
All the findings and results from the research will remain confidential. Apart
from the researchers in this study, doctors who involve in treating your baby and
participant’s family members, on one will not be known.

(13) Showing the results

Results from this study are expected to be shared, however, no identifying
information will be included with any of the results disseminated. These data will be
used and published in medical journals and medical conferences for giving valuable
information to other researchers.

(14) Right to refuse or withdraw

Your participation in this study is entirely voluntary. If you do not want to take
part in the study, there will be no change in the standard of health care you receive. If
you agree to take part in the study, you can change your mind later and withdraw at
anytime.

(15) Whom to contact

If you have any questions about this research, you may contact me at any time.
Dr. Aye Thuzar Kyaw
Specialist Assistant Surgeon (Pediatrics)
NICU, CWH, Yangon
Phone - 01-222811, Extension 1051
- 09-5390284