2.2 El bono de desarrollo humano
2.2.1 Antecedentes
1. EEG as well as video EEG diagnosed seizures especially among preterm babies who may not often manifest with clinically identifiable seizures is good prospect for future research activity.
2. The study of the prevalence of EEG confirmed seizure activities in clinically stable neonates and if this affect outcome will be worthwhile.
3. Follow up of babies with neonatal seizures to determine the prevalence of long-term neurological sequelea among this group of babies will also be worthwhile.
4. Population based study to access the burden of neonatal seizures in the community will be revealing for it is possible for a sizeable proportion of seizures in the newborn in the community to be missed by parents and thus may not present to health facilities.
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126 APPENDIX I
127 APPENDIX II
SUBJECT INFORMATION SHEET What is the study about?
This study is set out to know the number of babies with any uncontrollable abnormal movements of the face, eyes, mouth, hands or legs (seizures) among all the babies less than 28 days admitted into the ward. The study will also try to find the cause of these abnormal movements in these babies. We want to also compare this group of babies with other babies with no such abnormal movements and see how the movements affect their well-being.
Who are the participants?
You and your baby will be invited to join the study if your baby is less than 28 days and has abnormal movements of any part of the body.
What will be done?
The doctor will ask you some questions about yourself and the baby and then he will check your baby very well. To help the doctor know the cause of your baby’s abnormal movements, he will take about 4-5mls of blood (about one tablespoonful) from the arm of your baby for test in the laboratory. This will cause some pain and discomfort for your baby, but he/she will not be harmed. Also about 2-3mls of fluid (about one teaspoonful) will be collected from the back of your baby for test in the laboratory to see if germ in the brain and back (spinal cord) of your baby is the cause of the illness. This will also cause a brief pain and discomfort for your baby, but no long term problem. Your baby will also have a scan done
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on the head to know if bleeding into the brain is the cause of the abnormal body movements your baby is having.
Confidentiality
All information collected for the study will stay private.
You are free to choose to take part or not in this study. You also have the right to withdraw from the study at any time without giving any reason. You will still have normal access to health care for your child/ward whether you choose to join the study or not.
Further clarifications needed?
If you have further questions or clarifications concerning the study or care of your baby, please kindly contact Dr. Kuti, Bankole Peter at the Department of Paediatrics and Child Health, Wesley Guild Hospital, Ilesa. Mobile phone number 08034659848.
129 THE CONSENT FORM
The information has been read to me and I understand it/I have read and understood the information contained in the subject information sheet. I understand that the information regarding my baby/ward that is collected in the course of the study will remain confidential.
I understand that laboratory test will be performed on blood and cerebrospinal fluid samples collected from my baby/ward.
I understand that I am free to take part in the study or refuse without giving any reason. Deciding not to take part in the study will not affect the care of my baby/ward. I have had a chance to ask questions and I have had them answered.
Signature or thumb impression of mother/legal guardian--- Name of the child---Study no---
This form has been read by/ I have read the above to--- in a language that she understands. I believe that she understood what I explained and she has freely agreed to take part in the study.
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Signature of the personnel---
Name of the personnel---Date---
131 APPENDIX III MODIFIED BALLARD SCORE
132 APPENDIX IV Lubchencho intrauterine growth chart
133 APPENDIX V