DOC-20230314-WA0027

[Virtual Presenter] Protocol For Submission Of Thesis For The Award Of Degree Of Doctor Of Medicine Md Paediatrics Session: 2022-2025 Thesis Title Etiology Of Severe Hypertension In Children Aged 1 To 12 Years Dr. Sangeeta Saini Guru Gobind Singh Indraprastha University, New Delhi. Department Of Paediatrics Vardhman Mahavir Medical College And Safdarjung Hospital New Delhi 110029 I.

[Audio] Title Of Thesis: Etiology Of Severe Hypertension In Children Aged 1 To 12 Years Signature Of The Candidate: Name Of The Candidate: Dr Sangeeta Saini Pg Resident Department Of Paediatrics Vmmc And Sjh Hospital Signature Of The Supervisor: Name Of The Supervisor: Dr Ratan Gupta ,md Professor.

[Audio] Signature Of Principal: Name Of Principal: Dr. Geetika Khanna, Md Director Professor Of Pathology And Principal Vmmc And Safdarjung Hospital, New Delhi Signature Of The Medical Superintendent: Name Of The Medical Superintendent: Dr B L Sherwal, Md Professor And Consultant Medical Superintendent Vmmc And Safdarjung, Hospital, New Delhi Iii.

[Audio] declaration ForM CANDIDATE I, Dr sangeeta SAINI, hereby declare that the thesis protocol titled " ETIOLOGY OF severe HYPERTENSION IN CHILDREN aged 1 TO 12 YEARS" is being submitted by me to the Guru Gobind Singh Indraprastha University for the award of degree of Doctor of Medicine (Paediatrics). The topic of this thesis protocol has not been undertaken in the last five years under G-G-S-I-P University. I hereby declare that the thesis protocol does not violate the copyright act in any way, is free of plagiarism, and that the "questionnaires" or "scores" being used are copyright-free or that necessary permission has been obtained from the copyright holders. The work does not include any diagrams, figures, tables and flowcharts which are copied from a journal or a book or infringe copyright. signature OF THE CANDIDATE: name OF THE CANDIDATE: DR sangeeta SAINI PG resident department OF PAEDIATRICS VMMC AND SJH HOSPITAL iv.

[Audio] Certificate This Is To Certify That The Work Entitled "etiology Of Severe Hypertension In Children Aged 1 To 12 Years". Shall Be Carried Under Our Guidance And Supervision By Dr. Ratan Gupta In The Department Of Pediatrics. Vardhman Mahavir Medical College And Safdarjung Hospital, New Delhi Signature Of The Supervisor: Name Of The Supervisor: Dr Ratan Gupta Professor Department Of Paediatrics Vmmc And Sjh Hospital Signature Of The Co Supervisor: Name Of The Co-supervisor: Dr Rohini Gupta.

[Audio] CERTIFICATE This is to certify that the work entitled " ETIOLOGY OF severe HYPERTENSION IN CHILDREN aged 1 TO 12 YEARS " shall be carried out in the department of paediatrics, V-M-M-C and Safdarjung Hospital, New Delhi. This is certified that the study is feasible in the given time frame and that the institution has the study sample size that has been calculated based on relatable statistical formula, and that it satisfies the requirement of study design and the proposed statistical analysis. It is certified that the thesis plan is not a repetition of similar study undertaken in the previous 5 years in the university and that the study is not based on a retrospective collection or analysis of data from old patient case records and that it does not employ any of label drug trial. We undertake that the participants enrolled in this thesis project will not have to bear any financial burden on the account of investigation, devices implant, or drugs employed as a part of the study and that the study does not require us to partake of any obligation or any favor from pharmaceutical company device manufacturer or medical supplier. signature OF THE CANDIDATE: name OF THE CANDIDATE: DR sangeeta SAINI PG resident department OF PAEDIATRICS VMMC AND SJH HOSPITAL signature OF THE supervisor: name OF THE supervisor: DR ratan GUPTA PROFESSOR department OF PAEDIATRICS VMMC AND SJH HOSPITAL signature OF THE CO supervisor: name OF THE CO-SUPERVISOR: DR rohini GUPTA director PROFESSOR.

[Audio] Name Of The Head Of Department: Dr. Rani Gera, Md Professor And Head Of Department Of Paediatrics Vmmc & Safdarjung H Ospital, New Delhi Vii.

[Audio] INSTITUTIONAL review board CERTIFICATE The Institutional Review Board/ Thesis Protocol Review Committee of Vardhman Mahavir Medical College and Safdarjung Hospital has reviewed and discussed the research protocol entitled, "ETIOLOGY OF severe HYPERTENSION IN CHILDREN aged 1 TO 12 YEAR" . The Institutional Review Board duly reviewed the thesis protocol in line with the formally ratified 2019 regulation of the U-S-M and P-M-H-S-, Guru Gobind Singh Indraprastha University, and found the Introduction, Review of Literature, Lacunae in existing knowledge, Research question and Hypothesis, Aims and Objectives, Materials and Methods, Statistical methods, References, and Appendices to be suitably drawn and based on sound scientific and ethical foundation. The Institutional Review Board confirms that the supervisor and co-supervisor of the study meet the formally ratified 2019 regulations of the U-S-M and P-M-H-S-, Guru Gobind Singh Indraprastha University, and that neither the supervisor nor the co-supervisors are a part of thesis project more than permitted to them. The Institutional Review Board/ Thesis Protocol Review Committee meeting was chaired by Dr Jyotsana Suri (Obst. and Gynae.) and Dr Amita Malik (Radiology) and the following members of the committee were present during the meeting. 1. Dr Amitabh (Paediatrics) 2. Dr Garima Kapoor(Obs. and Gynae.) 3. Dr Neha Kawatra Madan (Pathology) 4. Dr Sugandha Arya (Paediatrics) 5. Dr Rachna Seghal (Paediatrics) 6. Dr Vandana Saini (Biochemistry) 7. Dr Shilpee Kumar (Microbiology) Institutional Review Board/ Thesis Protocol Review Committee approved the study to be conducted in the present form at Vardhman Mahavir Medical College and Safdarjung Hospital. Signed by the Chairperson, Institutional Review Board/ Thesis Protocol Review Committee Signed by the Dean/Head of Institution: Name of the Dean/ Head of the Institution: DR. GEETIKA KHANNA (M-D---) director PROFESSOR & PRINCIPAL VMMC & S-J-H--, N-E-W delhi viii.

[Audio] CONTENTS 1. Introduction 1-2 2. Review of Literature. 3-5 3. Lacunae in Existing Knowledge 6 4. Research question and Hypothesis. 7 5. Aim and Objectives. 8 6. Materials and Methods 9-14 7. References 15 8. Annexures (i) Annexure I 16-19 (ii) Annexure II 20-22 (iii)Annexure II. 23-24 (iv) Checklist..

[Audio] INTRODUCTION Pediatric Hypertension is defined as a sustained elevation of either systolic Blood pressure (S-B-P--) or Diastolic Blood pressure (D-B-P--) greater than or equal to 95th percentile for age , gender and height.¹ Stage 1 Hypertension is defined as systolic blood pressure or diastolic blood pressure ≥ 95th percentile to <95th percentile plus 12 millimetersHg or 130/80 to 139/89 ( whichever is lower) Stage 2 Hypertension is defined as systolic blood pressure or diastolic blood pressure ≥ 95th percentile plus 12 millimetersHg or 140/90 millimetersHg (whichever is lower).² National Health and Nutrition Examination Survey (NHANES) have shown that the morbidity of Hypertension in children is about 1-4 %.³ Blood pressure is recently increasing during childhood. Hypertension is uncommon in children. Hypertension in children is more commonly due to secondary causes, most common cause of severe hypertension in children is renal causes, renal parenchymal diseases and renovascular diseases accounts for majority.4 Chronic glomerulonephritis is most frequent cause in renal parenchymal diseases, Other causes of Hypertension in children are renal tumor, coarctation of aorta (cardiac cause) , pheochromocytoma, neuroblastoma, Cushing disease ( endocrine causes). Lee et.al study found that cancer was most common cause (47%) of hypertensive crisis, most of cancer patient showed Hypertensive crisis after receiving chemotherapy and kidney injury was second most common cause.2 Hypertensive crisis is defined as an acute episode of severely elevated BP with potential for end organ damage often exceeding the limits known for Stage 2 Hypertension while there is no Specific cutoffs in terms of BP for hypertensive crisis in pediatrics patients ( as in adults).⁵ Hypertensive crisis is an acute, life threatening elevation of BP and represents two processes that are pathophysiologically distinct, Hypertensive emergency and Hypertensive urgency. Hypertensive emergency is defined as sudden, severe hypertension complicated by acute organ damage. Hypertensive urgency is characterized by severely elevated BP without end organ damage.⁶ the clinical distinction between these two groups is presence or absence of target 1.

[Audio] Organ damage not by the absolute level of the BP.⁶ the definition of end organ damage was having signs or symptoms suggesting hypertensive emergency such as visual symptoms, seizure, anuria, hematuria or abnormal findings in a 12 lead E-C-G or Echocardiography.¹ organ involved in Hypertensive crisis are brain ,eyes, heart and kidneys.⁴ Hypertensive crisis may present with non specific symptoms like irritability, poor feeding, headache, nausea, fatigue and dizziness⁷. Hypertensive emergencies may present with distinct signs of acute neurological, visual, cardiac and renal damage. Out of these acute neurological signs ( Brain) are most common presentation and are result of disruption of blood – brain barrier, insufficient oxygen delivery, edema and microhemorrhage. The neurological symptoms may be non specific like Headache, dizziness, nausea and vomiting.⁸ A severe neurological complication of Hypertensive crisis in children is Post Reversible Encephalopathy Syndrome (P-R-E-S-) which damage the occipito – parietal white matter and may spread to basal ganglia, cerebellum and brain stem. In eye, Hypertensive emergencies may cause acute visual changes like acute ischemic optic neuropathy, papilledema, hemorrhage and cortical blindness.³ Hypertensive crisis can cause cardiovascular damage like left ventricular hypertrophy which may lead to congestive heart failure. Hypertensive crisis damage to kidney manifest as hematuria, flank pain and oliguria. Hypertension in children is recently increasing during childhood although it is uncommon in children but elevated BP in children causes various organ damage. Hypertension in children is more commonly due to secondary causes (mostly renal causes) and results in target organ damage. In this study etiology of severe hypertension in children 1 year to 12 years of age will be evaluated to know the etiology and target organ affected. 2.

[Audio] review OF literature Severe hypertension in children is characterized as an acute episode of severly elevated blood pressure with potential end damage often exceeding the limits known for Stage 2 Hypertension while there is no specific cutoffs in terms of blood pressure for Hypertensive crisis in pediatric patients is termed as Hypertensive crisis.¹ The hallmark of Hypertensive emergency is end organ injury, in pediatric patients brain is most commonly affected, other organ affected are eyes, heart and kidneys.⁵ There are various causes of Hypertensive crisis in children like renal causes, cardiac causes, endocrine causes, cancer and drug induced.² elevated blood pressure in children causes organ damage and results in Severe complications like P-R-E-S ( Posterior Reversible Encephalopathy Syndrome).⁶ There are only few studies in India on severe hypertension in children which shows renal causes and cancer were the most common cause of Severe hypertension in children. In a retrospective study conducted at Yonsei University college of medicine, Seoul , korea on etiologies and efficacy of drugs for Hypertensive crisis in children. 51 children was analysed and children are divided into two groups those diagnosed with Hypertensive emergency (hypertension with organ injury n= 31)and those diagnosed with Hypertensive urgency (hypertension without organ damage n= 20) and found that cancer was the most common cause (47%), most of cancer patients showed Hypertensive crisis after receiving chemotherapy and kidney injury was second most common cause (29.5%) there was no difference between nicardipine and labetalol for a rapid and controlled blood pressure decrease of administration in children with Hypertension and renal disease. Out of 51 children with hypertensive crisis 31 patients of hypertensive emergency.² 3.

[Audio] In another study in children on the incidence of Hypertensive emergencies the clinical presentation and etiology of Hypertensive crisis in children found that among 98 children with Hypertension, 30 had Hypertensive emergency, incidence was 0.3% and renal causes ( renovascular) were commenest. Headache, dizziness and vomiting were the commenest presentation. Half of them had encephalopathy.³ In another study conducted at B J Medical College Gujarat by Gosai et.al on Prevalence, clinical profile, etiology of hypertension and early outcomes of hypertension in hospitalized children and a total of 103 patients were included in the analysis and found that Prevalence of Hypertension was 0.96%, most common secondary cause of hypertension was renal disease with acute glomerulonephritis In a another study, it included 70 children with hypertensive crisis, patients were categorised into those diagnosed with Hypertensive emergency (n= 46) and those diagnosed with Hypertensive urgency (n=24). Etiologies and risk factors were compared between the two groups and found that Hypertensive crisis was most common among children aged 13-18 years, Hypertensive urgency was more common than hypertensive emergency. Hypertensive crisis is caused by secondary diseases, especially renal diseases and vascular diseases and combination therapy with antihypertensive agents and treatment of secondary etiology results in good prognosis.⁸ In another study, included 33 pediatric patients who were diagnosed as having hypertensive encephalopathy, to assess the clinical characteristics of hypertensive encephalopathy according to underlying etiologies and found that patient with renal origin hypertension had 4.

[Audio] more severe clinical course than those with non renal origin and renal origin group was highly associated with P-R-E-S (Posterior Reversible Encephalopathy Syndrome) on brain MRI.⁹ In a another prospective and descriptive study, patients aged 3 to 18 years admitted to hospital were taken. Patient' s demographic, history, clinical examination and laboratory investigations were done and main etiologies found were renal causes and diuretics were the main antihypertensive drugs used.¹⁰ In this study, children with severe hypertension will be assessed and etiology of severe hypertension and target organ affected will be evaluated. 5.

[Audio] lacunae IN EXISTING KNOWLEDGE There is paucity of data from Indian setting on etiology of severe hypertension in children aged 1 to 12 years. 6.

[Audio] research QUESTION What is the etiology of severe hypertension in children aged 1 year to 12 years ? 7.

[Audio] AIM AND OBJECTIVES AIM: To study etiology of severe hypertension in children aged 1 year to 12 years. Primary Objective To determine the etiology of severe hypertension in children aged 1 year to 12 years. Secondary Objective 1. To study the clinical profile and treatment given. 2. To determine target organ damage in patients with severe hypertension. 8.

[Audio] material A-N-D methods venue OF STUDY: Department of paediatrics and Department of Radiodiagnosis, Vardhman Mahavir Medical College & Safdarjung Hospital. TYPE OF STUDY: Cross sectional, observational study duration OF STUDY: 18 months sample size CALCULATION Taking the etiology of severe hypertension in children as per the study conducted by Lee GH et.al from Korea which was found that 2% was least etiology ( drug induced TIN). So, we will keep 2% as our proportion.2 Using the formula (Za/2)²×P×Q/L² P Etiology of severe Hypertension in children that is P = 2% Q= 100 – q = 100 – 2 = 98 L= 20% of P( relative error), that is 0.4 3.84×2×98/0.16 = 4700 But, looking into last year data there were only 50 patients matching our inclusion and exclusion criteria. Putting the finite population formula FP = Sample size /1 plus (ss-1/population) = 4700/1 plus (4699/50) = 50 Adding 10% error our final sample size is 55. 9.

[Audio] Inclusion criteria: Patients with systolic blood pressure or diastolic blood pressure ≥ 95th percentile plus 12 millimetersHg or 140/90 millimetersHg for age, gender and height (whichever is lower)in children aged 1 year to 12 years. Exclusion criteria: 1. Immediate post operative case 2. Hypertension due to raised intracranial pressure 10.

[Audio] STUDY FLOW CHART Children with severe Hypertension admitted at Paediatric Emergency Department-consent taken at the time of admission Patient's demography and clinical profile will be noted in prescribed proforma Four limb Blood pressure will be recorded after initial assessment Patient will be investigated and managed for severe Hypertension as per departmental policy. 11.

[Audio] methodology This is a cross sectional observational study in which Blood pressure will be measured in all admitted patient between the age group of 1 year to 12 years as a part of vital monitoring after taking consent at the time of admission. Our study include children of age group 1 year to 12 years with diagnosis of severe hypertension and are symptomatic with significant elevation in blood pressure with or without end organ damage. Exclusion criteria include immediate post operative cases and hypertension due to raised intra cranial pressure. We will be measuring the blood pressure by Aneroid sphygmomanometry using auscultatory method with appropriate sized cuff. If the initial reading is raised (>90th) than an average of three readings will be taken. While measuring the blood pressure the child should be in sitting position or lying down whichever is comfortable and it should be measured in the right arm by using standard measurement practices with proper cuff size, cuff bladder length (encircling 80% to 100%) of the arm circumference, cuff bladder with a width to arm circumference ratio of 0.45 to 0.55. All the recordings should be done after taking proper history and physical examination. We will do a thorough clinical assessment of the children with severe hypertension with initial work up of complete blood count, serum chemistry, urine analysis for cells protein, dysmorphic R-B-C--, culture, blood urea creatinine, serum electrolytes, uric acid, calcium, fasting cholesterol, chest x ray, E-C-G--, echocardiogram, fundus examination, abdominal ultrasound,99 meters Tc-DMSA scan and additional investigation with sustained hypertension, micturating cystourethrogram, renal imaging, computed tomography angiography or magnetic resonance angiography for evaluation of renal artery stenosis, 12.

[Audio] Computed tomography/magnetic resonance imaging of brain for neurobiological involvement like posterior reversible encephalopathy syndrome and haemorrhage. Subsequent workup and treatment will be done as per the protocol. All enrolled patient will be followed throughout hospital stay , and clinical details will be recorded on daily basis till death or discharge from the hospital . 13.

[Audio] STATISTICAL analysis Data will be coded and recorded in MS Excel spreadsheet program. S-P-S-S v21 (IBM Corp.) will be used for data analysis. All the continuous variables will be represented as mean± SD and the range will be mentioned. Categorical variables will be analysed by Chi-square test& Fisher's Exact test and P value <0.05 will be considered significant. The clinical outcome will be correlated with the referral background using regression analysis. Binomial & multinomial regression will be used & fit of the final model will be assessed. 14.

[Audio] refrences 1. Raina R, Mahajan Z, Sharma A, Chakraborty R, Mahajan S, Sethi SK, and others hypertensive crisis in pediatric patients: an overview. Front Pediatr. 2020; 8:588-611. 2. Lee GH, Lee IR, Park SJ, Kim JH, Oh JY, Shin JI. Hypertensive crisis in children: an experience in a single tertiary care center in Korea. Clin hypertens. 2016;22:10. 3. Kotapuri S, Putta M, Chitgupikar S Study of clinical and etiological profile of hypertensive emergencies in children admitted in pediatric emergency department. Int J contemp pediatr 2021;8:797-802. 4. Gosai D, Shah B, Chaudhary K, Das A Childhood hypertension: An observational study from a Tertiary Care Centre, Gujarat, India. J of Clinical and Diagnostic Research 2017.6: 234-57. 5. National High Blood Pressure Education Program Working Group on hypertension Control in Children and Adolescents. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and addolescents. Pediatrics. 2004;114:555–76 6. Hari P, Bagga A, Srivastava N Sustained hypertension in children. Indian Pediatr. 2000;37:268–74. 7. Hari P, Sinha A Hypertensive emergencies in children. Indian J Pediatr.2011. 78:569–75. 8. Ba H, Peng H, Xu L, Qin Y and Wang H (2022) Clinical Characteristics of Hospitalized Pediatric Patients With Hypertensive Crisis—A Retrospective, Single-Center Study in China. Front. Cardiovasc. Med. 2022.9:891-904. 9. Ahn CH, Han SA, Kong YH, Kim SJ. Clinical characteristics of hypertensive encephalopathy in pediatric patients. Korean J Pediatr. 2017. 10. Yang WC, Wu HP. Clinical analysis of hypertension in children admitted to the emergency department Pediatr Neonatol. 2010;51:44–51. 11. Nirali H Patel, Sarah K Romero, David C Kaelber. evaluation and management of pediatric hypertensive crises: hypertensive urgency and hypertensive emergencies. Open Access Emerg Med. 2012; 4:85–92. 15.

[Audio] ANNEXURE 1 patient STUDY PROForMA Name: Age/Sex: Contact number: M-R-D No: Date and time of Admission: Address Condition at time of admission as per assessment triangle Initial evaluation (P-A-T--) Appearance Normal/ Abnormal Work of breathing Normal/ Increased/ Decreased/ Gasping/ Apnea Classification after P-A-T Respiratory distress Respiratory failure Shock -compansated/ decompansated Cardiopulmonary failure / Arrest C-N-S system/ metabolic dysfunction TRIAGE CATEGORISATION R-E-D yellow GREEN PRIMARY EVALUATION (A-B-C-D-E) ASSESSMENT pentagon AIRWAY Open and stable: Open and unstable : Obstructed BREATHING RR….. Efforts: Normal/ Poor/Increased Auscultation: Normal/ Poor/ Increased Added sound: None/Stridor/ wheeze/crackles SpO2(room air)….. 16.

[Audio] CIRCULATION HR/ PR…. CFT…. BP… Peripheral pulses:Good/ Poor Central pulses: Good/Poor Skin temperature: Warm/ Cool ECG: disability Pupil Size: Reaction : Motor Activity: Normal and symmetrical/ Asymmetrical/ Posturing/ Flaccidity/ Seizures/ E-P-S Blood sugar EXPOSURE Temperature: Colour: Normal/ Pallor/ Cyanosis/ mottlee Any other skin lesions Petechial/ bleeding/ rash/ pustules/ abcess/ any other Chief Complains: Intervention done at emergency: DD: Investigations done during hospital stay: History of present illness 17.

[Audio] Past history Birth history ( antenatal/ natal/ postnatal) Feeding history Development history Immunisation history Family history 18.

[Audio] Vitals at admission HR: RR: BP: Temp: BP Centiles separately for boys ang girls according to Age, sex and height General physical examination: Pallor Icterus Cyanosis Clubbing Lymphadenopathy Dysmorphism Pedal edema Jugular venous pressure Others Systemic Examination Differntal Diagnosis Final Diagnosis 19.

[Audio] patient INForMATION SHEET Your child is being invited to participate in a research study. Before you take part in this research study, we wish to explain the study to you and give you the chance to ask questions please read carefully the information provided here if you agree to participate, please sign the informed consent form. S-T-U-D-Y title: ETIOLOGY OF severe HYPERTENSION IN CHILDREN aged 1 TO 12 YEARS purpose OF research STUDY: To evaluate the Etiology of children (1 year to 12 years) with severe hypertension. STUDY PROCEDURES AND visit SCHEDULE: Admitted children (1 year to 12 years) with severe hypertension will be examined and followed. During the course of the study the child will not undergo any procedure which will pose to be a threat to his or her life withdrawl FROM STUDY: you have the right to withdraw your child from study at any time during the study without any prejudice to you or your family is right to undergo future treatment at Safdarjung hospital. Your decision not to participate in research study will not affect the medical care in this institution. benefits OF THE STUDY: By obtaining and analyzing the data, we can avoid the modifiable risk factors responsible for vital organs damage due to severe hypertension. subject rights: It is your right to decide whether to take part in the study you are free to ask if you have any queries or concerns. CONFIDENTIALITY OF STUDY AND medical records: Record of your child participation will be kept confidential. Any publication of data will not be identified by your child by name. By signing the consent form you authorise the sharing of your child study related medical records to the regulatory authorities and institutional ethical committee. 20.

[Audio] WHOM TO CONTACT IF You HAVE QUESTION: DR sangeeta SAINI DR ratan G-U-P-T-A (M-D---) PG Resident Professor Department of Paediatrics Department of Paediatrics VMMC & S-J-H--, New Delhi VMMC & S-J-H--, New Delhi 8076794386 9990388644 21.

[Audio] अनुलग्नक 2: रोगी जानकारी पत्र आपके बच्चे को एक शोध अध्ययन में भाग लेने के ललए आमंलित लकया जा रहा है। इससे पहले लक आप इस शोध अध्ययन में भाग लें, हम आपको अध्ययन की व्याख्या करना चाहते हैं और आपको प्रश्न पूछने का अवसर देना चाहते हैं, कृ पया यहां दी गई जानकारी को ध्यान से पढें यलद आप भाग लेने के ललए सहमत हैं, तो कृ पया सूलचत सहमलत फॉमम पर हस्ताक्षर करें। अध्ययन शीर्षक: 1 से 12 वर्म की आयु के बच्चों में गंभीर उच्च रक्तचाप की एलियललज अनुसंधान अध्ययन का उद्देश्य: गंभीर उच्च रक्तचाप वाले बच्चों (1 वर्म से 12 वर्म) के एलियललज का मूल्ांकन करना अध्ययन की प्रक्रिया और मुलाकात का कायषिम: गंभीर उच्च रक्तचाप वाले भती बच्चों (1 वर्म से 12 वर्म) की जांच की जाएगी और उनका पालन लकया जाएगा। अध्ययन के दौरान बच्चे को ऐसी लकसी भी प्रलिया से नहीं गुजरना होगा जो उसके जीवन के ललए खतरा हो अध्ययन से नाम वापस लेना: आपको अध्ययन के दौरान लकसी भी समय अपने बच्चे को अध्ययन से वापस लेने का अलधकार है, लबना लकसी पूवामग्रह के आपको या आपके पररवार को भलवष्य में सफदरजंग अस्पताल में इलाज कराने का अलधकार है। शोध अध्ययन में भाग न लेने के आपके लनर्मय से इस संस्थान में लचलकत्सा देखभाल प्रभालवत नहीं होगी। अध्ययन के लाभ: डेिा प्राप्त करने और उसका लवश्लेर्र् करने से, हम गंभीर उच्च रक्तचाप के कारर् महत्वपूर्म अंगों की क्षलत के ललए लजम्मेदार पररवतमनीय जोखखम कारकों से बच सकते हैं। लवर्य अलधकार: यह तय करना आपका अलधकार है लक अध्ययन में भाग लेना है या नहीं, आप पूछने के ललए स्वतंि हैं लक क्या आपके कोई प्रश्न या लचंताएँ हैं। अध्ययन और क्रिक्रकत्सा ररकॉर्ष की गोपनीयता: आपके बच्चे का ररकॉडम भागीदारी गोपनीय रखी जाएगी। डेिा के लकसी भी प्रकाशन की पहचान आपके बच्चे द्वारा नाम से नहीं की जाएगी। सहमलत फॉमम पर हस्ताक्षर करके आप अपने बच्चे के अध्ययन संबंधी मेलडकल ररकॉडम को लनयामक प्रालधकरर्ों और संस्थागत नैलतक सलमलत को साझा करने के ललए अलधकृ त करते हैं। यलद आपका कोई प्रश्न है तो दकससे संपकक करें: डॉ. संगीता सैनी डॉ रतन गुप्ता (एमडी) पीजी रेदजडेंि प्रोफे सर बाल रोग लवभाग बाल रोग लवभाग वीएमएमसी और एसजेएच, नई लदल्ली 8076794386 वीएमएमसी और एसजेएच, नई लदल्ली 9990388644 22.

[Audio] ANNEXURE 3 INForMED CONSENT ForM S-T-U-D-Y title: ETIOLOGY OF severe HYPERTENSION IN CHILDREN aged 1 TO 12 YEARS subject number/ID: subject'S name: I confirm that I have read and understood the information sheet for the above and had the opportunity to ask the questions. I understand that the participation of my child in the study is voluntary and I reserve my rights to withdraw my child from the study whenever I wish. I_____________, son/daughter/ of —————-, resident of———, do hereby give my consent for participation of my child in the study. I also agree to allow use of data arising from this study for scientific purpose(s) without disclosing my child identity. Signature/left thumb impression of father/mother/guardian: Name of father/mother/guardian: Date and Time: We have witnessed that the patient's father/mother/guardian signed the above form in presence of his free will after having fully understood its contents. 1. Signature of witness: Name of witness: Full address: 2.Signature of witness: Name of witness: Full address: signature OF THE CANDIDATE: name OF THE CANDIDATE DR. sangeeta SAINI PG resident department OF PAEDIATRICS VMMC AND SJH, N-E-W delhi 23.

[Audio] अनुलग्नक 3. सूक्रित सहमक्रत प्रपत्र अध्ययन शीर्षक: 1 से 12 वर्म की आयु के बच्चों में गंभीर उच्च रक्तचाप की एलियललज. क्रवर्य संख्या / आईर्ी: क्रवर्य का नाम: मैं पुलि करता हं लक मैंने उपरोक्त के ललए सूचना पि को पढ और समझ ललया है और मुझे प्रश्न पूछने का अवसर लमला है। मैं समझता हं लक अध्ययन में मेरे बच्चे की भागीदारी स्वैखिक है और जब भी मैं चाहं अपने बच्चे को अध्ययन से वापस लेने का अलधकार सुरलक्षत रखता हं। मैं____________, पुि/पुिी/———————— का लनवासी———, इसके द्वारा अपना अध्ययन में मेरे बच्चे की भागीदारी के ललए सहमलत। मैं अपने बच्चे की पहचान का खुलासा लकए लबना वैज्ञालनक उद्देश्यों के ललए इस अध्ययन से उत्पन्न होने वाले डेिा के उपयोग की अनुमलत देने के ललए भी सहमत हं। लपता/माता/अलभभावक के हस्ताक्षर/बाएं अंगूठे का लनशान: लपता/माता/अलभभावक का नाम: लतलथ और समय: हमने देखा है लक मरीज के लपता/माता/अलभभावक ने उपरोक्त फॉमम पर उसकी सामग्री को पूरी तरह से समझने के बाद अपनी स्वतंि इिा की उपखस्थलत में हस्ताक्षर लकए। 1. गवाह के हस्ताक्षर: गवाह का नाम: पूरा पता: 2.गवाह के हस्ताक्षर: गवाह का नाम: पूरा पता: उम्मीदवार के हस्ताक्षर: उम्मीदवार का नाम: डॉ. संगीता सैनी पीजी लनवासी बाल रोग लवभाग वीएमएमसी और एसजेएच, नई लदल्ली 24.

[Audio] University School of Medicine and Paramedical Health Sciences Guru Gobind Singh Indraprastha University, New Delhi Candidate's Checklist Name: Dr sangeeta SAINI Course: MD Paediatrics Institution: Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi Title of the Thesis Protocol: ETIOLOGY OF severe HYPERTENSION IN CHILDREN aged 1 TO 12 YEARS S No. Checklist for Thesis Place (√) or (×) Protocol Title Page of the Protocol 1. Does the title reflect the aims and objective(s) of the proposal? √ √ 2. Does the title page include your name, course, batch year, college, university? First Preliminary Page of the Protocol 3. Does the page carry your name and signature? √ √ 4. Does the page carry the name, university designation and signature of your thesis supervisor? √ 5. Does the page carry the name, university designation and signature of the co-supervisor/s? √ 6. Does the page carry the name and signature of your Head of Department? √ 7. Does the page carry the name and signature of your Head of Institution? Undertaking and Certificates √ 8. Have you attached the declaration (5.5.1) that the thesis protocol does not violate the copyright act in any way, is free of plagiarism, and you've not reproduced any "questionnaires", "scores", diagrams, figures, tables, flowcharts which may infringe the copyright act? √ 9. Have you attached your supervisor's and co-supervisors certificate (5.5.2) that they would supervise and guide your work? √ 10. Have you attached certificate (5.5.3) bearing your own, your supervisor's, your co-supervisors' and Head of Department's signatures asserting the feasibility of the study; the study sample size having been calculated on the basis of relatable statistical formula and satisfying the requirements of study design and the proposed statistical analysis; the thesis plan not being a repetition of a similar work undertaken in the previous 5 years; the plan not entailing a retrospective collection or analyses of data from old patient case records; not employing any "off-label drug trial"; assertion that participants would not bear any financial burden on account of the investigations, devices,implants or drugs employed; and that the study would not require you to take any 25.

[Audio] obligation from a pharmaceutical company, device manufacturer or medical supplier? √ 11. Have you attached the certificates of your Institutional Review Board (I-R-B--)/Thesis Protocol Review Board (5.5.4) and Institutional Ethics Committee (I-E-C--) (5.5.5) conveying their formal approval of the project in the study protocol? Table of Content √ 12. Have you drawn a table of contents and numbered all pages of the protocol in the following sequence: Introduction; Review of Literature; Lacunae in existing knowledge; Research question and Hypothesis; Aims and Objectives; Material and Methods; Statistical methods; References; Appendices? Introduction √ 13. Have you provided a brief description of the existing knowledge on your research topic under "Introduction"? Review of Literature (R-O-L--) √ 14. Have you exhaustively reviewed the current literature on the research topic and presented a comprehensive summary of the current knowledge in a lucid manner under the Review of Literature? Research Question and Hypothesis √ 15. Have you clearly stated the research question that you wish to resolve? √ 16. Does the hypothesis match the research question and is it based on a sound scientific presumption? Aims and Objectives 17. Have you clearly stated the Aims and Objectives of the study? √ 18. Is the Aim in accordance with the research topic? √ 19. Are the Primary Objectives clearly stated? √ 20. Are the Secondary Objectives clearly stated? √ 21. Are the Objectives aligned with the research subject? √ 22. Are the Objectives achievable in a specified time frame? √ 23. Are the Objectives achievable within the existing resources? √ Materials and Methods 24. Have you stated the place of study? √ 25. Have you stated the period of study? √ 26. Have you stated the type of study you're undertaking? √ 27. Does the stated study type match with the research design? √ 28. Is the study population defined? √ 29. Is the method of recruitment defined? √ 30. Are the inclusion criteria defined? √ 31. Are the exclusion criteria defined? √ 26.

[Audio] 32. In studies where applicable, are the study groups defined? √ 33. Do you intend to employ a control group? 34. Is the control group suitably matched to the participants of the study? √ 35. Is the study sample size calculated on the basis of a sound relatable statistical formula? √ 36. Does the study sample size match the study design and statistical methods you propose to employ on the data? 37. Have you included a detailed study flow chart in the protocol? √ √ 38. Have you included the details of the proposed investigations and how they relate to your study? 39. Do you intend to carry out any interventions? X 40. Have you included the details of the proposed interventions? 41. Do you have a gold standard to clinch the diagnosis? √ 42. How accurate is the gold standard? √ 43. Have you included the outcome measures? 44. Have you included any "clinical scores"? X 45. If yes, are these "clinical scores" copyright free? 46. If copyrighted, have you taken steps to ensure you do not violate the copyright? Statistical methods √ 47. Have you stated the statistical methods you would employ to gauze the obtained data? √ 48. Have you explained how the stated statistical methods would be employed to obtain results? References √ 49. Have you numbered each reference beginning with page 1 of the introduction and till the end of the protocol in a continuous sequence in order of their appearance (as is prescribed in Vancouver style)? √ 50. Have you cited the references as they appear within the text in Arabic numerals? √ 51. Under the reference section, have you listed the details of each reference as is prescribed in Vancouver style? Appendix 52. Does the protocol carry any questionnaire? X 53. Is the questionnaire validated? 54. Is the questionnaire copyright free? √ 55. Have you included a detailed study pro forma to capture all significant elements of the study? Patient Information sheet (P-I-S--) 56 Have you included P-I-S in Hindi? √ . 57 Have you included P-I-S in English? √ . 58 Does the P-I-S state the purpose of the study? √ . 59 Does it mention how it is going to benefit the participants? √ 27.

[Audio] . 60 Does it state the procedures and tests to be done? √ . 61 Does it elaborate how the procedures and tests will be done? √ . 62 Does it mention the potential side effects and/or risks? √ . 63 Does it include your and your supervisor's name and contact number? √ . 64 Have you clearly stated any know ethical issue(s)? . Informed Consent Form 65. Have you included an informed consent form in Hindi? √ 66. Have you included an informed consent form in English? √ √ 67. Does the informed consent form bear the name, address, contact number and signature of the participant? √ 68. Does the informed consent form bear the name, address, contact number and signature of a witness? Binding 69 Is the thesis protocol firmly bound? √ . Candidate's Checklist √ 70. Have you submitted the filled up Candidate's Checklist in the bound thesis protocol? Signature of the Candidate: Name of the Candidate: DR. sangeeta SAINI PG Resident Department of Paediatrics VMMC & S-J-H--, New Delhi Signature of the Supervisor: Name of the Supervisor: DR. ratan GUPTA Professor Department of Paediatrics VMMC & S-J-H--, New Delhi 28.

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