MATERNAL PREDICTORS OF INFANT OUTCOME IN PRE-ECLAMPSIA AND ECLAMPSIA AT THE JOS UNIVERSITY TEACHING HOSPITAL, JOS
Principal Investigator: Christopher Sabo Yilgwan
Co-Investigators: Pam VC, Ige OO
Department of Paediatrics, Jos University Teaching Hospital, Jos
E mail: yilgwanc@unijos.edu.ng, yilgwan@hotmail.com
Phone number: 08023706039
Purpose of research: To investigate the maternal predictors of infant outcome in Pre-eclampsia and Eclampsia in the Jos University Teaching Hospital, Jos
Date of commencement: Jan 2016
Mentors: Prof. Fidelia Bode- Thomas, FWACP, MSc (PH), Prof. Stephen Oguche, FMCPaed
Department of Paediatrics
University of Jos, Jos
- Abstract
Background
Preeclampsia/eclampsia(PE/E) has remained a significant public health problem in Nigeria and the developing world where it is said to complicate about 2-10% of all pregnancies resulting in a five-fold increase in perinatal morbidity and mortality.1 Research has shown that about 25% of the babies born to mothers with pre-eclampsia are growth restricted while a further third are likely to be born premature.2,3 In most cases, the child may have problems with neurocognitive development that can result in mild learning difficulties through to severe disabilities. Being born growth restricted also predisposes the child to cardiovascular disease as an adult. Besides, pre-eclampsia accounts for a sizable percent of neonatal intensive care unit costs. In a country like Nigeria with scarce health resources, this can have a significant impact on the economy of the nation. 4-7
PE is a pregnancy-specific disorder characterized by hypertension, significant proteinuria, with or without edema.2 Evidence suggests that PE/E, or its maternal complications may develop without hypertension or proteinuria being evident making the dependence on the diagnostic criteria unreliable.2,8,9 Because of its unpredictability, varying clinical presentation and potential infant adverse outcomes, pregnant women with suspected preeclampsia require intensive monitoring or hospitalization. Beyond preeclampsia diagnosis, there is a high unmet medical need for more reliable infant outcome predictive markers to improve outcomes and reduce unnecessary hospital admissions.5-7 An imbalance of circulating angiogenic and antiangiogenic factors, including raised soluble fms-like tyrosine kinase-1 (sFlt-1) and decreased placental growth factor (PlGF), has been found in women diagnosed with preeclampsia before clinical onset of the disease.8,9 These markers have been thought to mediate the inflammatory process initiating the onset of the disease and as such have a potential for use in early and timely diagnosis and management of these women thereby leading to improved outcome for their babies.8,9 Correlation of these markers, maternal sociodemographic and clinical parameters with infant outcome can be a valuable tool in early diagnosis and the prediction of those women with the highest potential for poor infant outcome thereby helping to reduce perinatal morbidity and mortality from preeclampsia/eclampsia.8,9
Studies from various centers in Nigeria have reported on outcomes of infants born to women with PE/E as being poor with low birth weight, prematurity and severe birth asphyxia as the most prevalent problems associated with poor outcomes in these infants. While not all infants born to preeclamptic/eclamptic women have poor outcome at birth and beyond, few studies have examined the factors that predict infant outcome following preeclamptc/eclamptic pregnancies. 4-6,10,11 Most of these studies focused on clinical and sociodemographic factors instead of a composite of the sociodemographic, clinical and inflammatory process that initiates and contributes to the myriad of problems associated with the disorder.4-6,10,11 None of such studies to our knowledge were conducted in Nigeria. This proposed research seeks to investigate those maternal sociodemographic. clinical and biochemical parameters that will predict infant outcome following preeclamptic/ eclamptic pregnancy in order to identify a subset of women that are likely to have an infant with poor outcome so as to help change approach to management of PE/E through early diagnosis and management.
We thus hypothesize that maternal sociodemographic, clinical and biochemical parameters significantly influence infant outcome in women with preeclampsia/eclampsia. Our specific aim is first to determine infant outcomes in women with PE/E. Secondly, we seek to dichotomize the women into subsets based on the infant outcomes in order to determine which maternal factors are significantly associated with poor infant outcome in PE/E.
It is hoped that this study will help to bridge the management gap between obstetricians and neonatologist through improved collaborative care beginning from the time of antenatal diagnosis of PE/E to the delivery of the baby thereby improving care for these infants. Secondly, we also hoped to use the findings and tissue banked in this study for future epigenetic studies and to lay the foundation for the understanding of how perinatal and early life events can explain the relationship between intra-uterine stressor events occasioned by preeclampsia and eclampsia in relation to the development of cardiovascular disease (CVD) risk factors in later life.
SUBJECTS AND METHODS
Study Setting
The Jos University Teaching Hospital is a 500 bed capacity hospital that serves about 8 states within the North central and parts of North eastern Nigeria. It is a tertiary care academic institution used to attracting grant aided research. The hospital runs daily antenatal clinics with an average of 120 women seen daily out of which 10 new cases are reviewed on each clinic day. It has an annual delivery rate of about 4,000 babies with preeclampsia/eclampsia complicating about 10% of those deliveries annually.
Study population
The study population will consist of pregnant women presenting to JUTH with a diagnosis of preeclampsia or eclampsia.
Inclusion criteria: All women at the antenatal clinic with a diagnosis of preeclampsia/eclampsia who give their informed consent.
Exclusion criteria: women who have other chronic disorders like diabetes etc . No woman shall be excluded on the basis of her age, parity, ethnic group, race, religion or other affiliations.
Pre-eclampsia will be defined as systolic blood pressure ≥140 mmHg or diastolic pressure ≥90 mmHg, (or increases of 30 mmHg systolic or 15 mmHg diastolic from the baseline) on at least two occasions six or more hours apart and associated proteinuria that develops from the 20th gestational week in a previously normotensive woman. Eclampsia will be defined as the onset of convulsions described as grand-mal type seizures first appearing before or during labour, or within 48 hours from delivery, and/or coma unrelated to other cerebral conditions in women with pre-eclamptic signs and symptoms.
Study design
This will be a prospective cohort study comparing a sample of women followed up in the antenatal unit of the Jos University Teaching Hospital (JUTH) with a diagnosis of pre-eclampsia with normotensive women for the assessment of their fetal and infant outcome. The sample size is determined using OpenEpi version 3.03a to be 90 (45 women in each arm) based on the estimated effect size of 20%, a power of 80%, α level of 0.05 and an attrition rate of 10%.
Maternal selection
Each woman who consented to the study will be enrolled after obtaining informed consent. An interviewer administered questionnaire will be used to obtain socio-demographic and relevant clinical history. In addition, standard methods/protocols for weight and height measurements will be used to obtain her baseline anthropometric parameters. Blood pressure will be measured using the JNC 7 protocol after which a unique identification number will be given to her. Clinical review of each participating pregnant woman will be done at her regular antenatal visits until delivery of the baby. Serum samples will be collected baseline and at delivery for biochemical assay of placenta derived growth factor, highly sensitive C-reactive protein and procalcitonin assessment.
Infant assessment
At delivery, basic anthropometric data (such as weight, length, head circumference, thoracic circumference) and physiologic parameters (eg APGAR scores) will be obtained from the baby using standard methods/protocols. Cord blood assay for pro-BNP using commercially available analytic systems will be done. The infant anthropometric measurements will be used in classifying the birth weight according to the WHO classification while APGAR scores will be used to evaluate the presence of birth asphyxia.
Each infant will also undergo a trans-thoracic screening echocardiography using a portable sonosite echocardiographic machine at birth for the assessment of functional and structural cardiac dysfunction. Echocardiograpy will be done because of the relative risk of congenital heart disease such as patent ductis arteriosus in premature and low birthweight infants because of its potential contribution to morbidity and thus outcomes in these infants. Bone density scan to assess bone age and developmental assessment will be done at birth using Dubowitz method. (The Dubowitz method of gestational assessment assesses neuromuscular maturity in newborns). Bone density scan and developmental assessment will help to validate gestational age assessment for the infants especially since health literacy in Nigeria is low with many of the women usually unsure of their dates.
Study outcomes
The primary outcome of interest will be an adverse neonatal/infant event. An adverse neonatal outcome will be defined as one or more of the following: Low birth weight (baby weighing less than 2500gm), Prematurity (a baby born before 37 completed weeks), Birth asphyxia (Based on APGAR scores) and need for admission to the special care unit.
The secondary outcome of interest will be infant death occurring in the first 12 months of life. Subset of this outcome such as still birth rate, perinatal, neonatal and infant mortality rates will also be ascertained. A still birth will be defined as delivery of a baby that died in the uterus after 28 weeks of gestation. An early neonatal death will be defined as any infant death within the first seven days of life. Overall neonatal death will be defined as death of a baby in the first twenty eight days after delivery while perinatal death will be defined as all stillbirths plus early neonatal deaths.
Definition of poor infant outcome
The presence of any one or a combination of the following will define poor infant outcome
- Low birth weight
- Prematurity
- Severe birth asphyxia
- Admission into the neonatal care unit for any co-morbidity at birth
Ethical consideration
Ethical clearance will be obtained from the research and ethics committee of the Jos University Teaching Hospital before the commencement of the study.
Statistical analysis
The baseline characteristics of study subjects will be described using proportions, median, inter-quartile range, mean, standard deviation, frequency and percentage. For comparisons between poor infant outcome group and good infant outcome group, the student’s t test will be used for continuous variables and chi square for categorical data. To identify the sociodemographic, clinical and behavioural predictors independently associated with infant outcome in the poor outcome or good infant outcome groups; univariate and multivariate analyses will be performed using Cox regression analyses. The criterion for significance for all analyses will be set at a P-value of α = 0.5. All statistical analyses will be done with the statistical software package SPSS version 20.
- BUDGET
PROPOSED BUDGET FOR THE STUDY:
ITEM QUANTITY FREQUENCY UNIT COST(N) TOTAL COST(N)
Personnel:
Research Assistant 1 12months 25,000 300,000
Materials and supplies:
Sample bottles 1000 5/ Subject 30 30,000
Vacutainers 150 1/ Subject 100 15,000
Spirit swabs 750 2/Subject 50 37,500
Laboratory Investigations:
Procalcitonin 300 1/ Subject 1,250 400,000
Placenta derived growth
factor Assay 300 1/ Subject 1,350 432,000
C reactive protein 300 1/ Subject 800 256,000
GRAND TOTAL 1,470,500
GRAND TOTAL= N1, 403, 000 (ONE MILLION, FOUR HUNDRED AND SEVENTY THOUSAND, FIVE HUNDRED NAIRA ONLY)
- BUDGET JUSTIFICATION
Principal Investigator: Yilgwan, Christopher Sabo
Project title: Maternal predictors of Infant outcome in a cohort of women treated for Pre-eclampsia and Eclampsia in the Jos University Teaching Hospital, Jos
Personnel:
Mentor: Prof. Fidelia Bode- Thomas. Will provide scientific support and supervision throughout the duration of the research. No salary requested.
Principal Investigator: Dr Yilgwan, Christopher Sabo. Will oversee all aspects of the research - protocol design, recruitment, data collection, analysis and interpretation of results. No salary requested
Co- Investigators: Drs Pam VC and Ige OO. Will be involved in data collection, analysis and interpretation of results. No salary requested
Research Assistant: Will coordinate research logistics, data collection and laboratory investigations. Allowance per month is N25, 000
Others:
Cryovials: These will be used to collect the serum samples for laboratory assay of placenta derived growth factor, procalcitonin and C-reactive protein
Publication costs: Research findings will be published in a peer- reviewed journal
Travel costs: Research findings will be presented at a conference
- Project Narrative
This is a study on infant outcome in preeclamptic/eclamptic women. It explores the impact of preeclampsia/eclampsia on infant outcomes using parameters such as birth weight, gestational age, APGAR scores and comorbid medical conditions in the early neonatal period in assessing the risk of low birth weight, prematurity, birth asphyxia and need for special care baby unit (SCBU) admission as primary end points respectively. The study seeks to investigate maternal sociodemographic, clinical and biochemical factors that are predictive of infant outcome. The study also aimed to secondarily assess the mortality rate of these infants in the first 28 days of life. The results of this study will thus help us to better understand the best strategy to improve our obstetrics and neonatal care in order to improve infant morbidity and mortality for babies born following a preeclamptic/eclamptic pregnancy. This would serve to bridge the management gap between obstetricians and neonatologist thereby resulting in increase collaborative care and thus improve infant outcome for these women.
- Research Plan
The overall aim of this research is to determine the maternal sociodemographic, clinical and biochemical factors predicting infant outcome in preeclamptic and eclamptic women through antepartum maternal clinical and laboratory surveillance/ screening.
The primary research question is ‘Does maternal clinical and laboratory surveillance result in significantly improved infant outcome for preeclamptic/eclamptic women? Our secondary hypothesis is that maternal magnesium sulphate use in the immediate antepartum period may result in better infant outcome in preeclamptic/eclamptic women.
- Specific aims
- To determine Infant outcome in women treated for Pre-eclampsia and Eclampsia in the Jos University Teaching Hospital, Jos
- To determine the difference if any in infant outcome between pre-eclamptic/eclamptic women treated with magnesium sulphate and those who were not treated with magnesium sulphate
- To determine the maternal sociodemographic and clinical predictors independently associated with infant outcome in pre-eclamptic/eclamptic women
Background and significance
Pre-eclampsia is a pregnancy-specific disorder characterized by hypertension, significant proteinuria, with or without edema.2,3,8 It is multifactorial and forms an integral part of the continuum of hypertensive disorders of pregnancy.2,3 Its pathophysiology is incompletely understood but is said to consist of generalized endothelial dysfunction initiated by abnormal placentation that is associated with different degrees of fetal injury though perinatal outcome is influenced by the gestational age and the severity of the hypertension. 2,3,8The immediate fetal impact observed is altered growth resulting in greater fetal liability while long term complications such as hypertension, coronary artery disease, and diabetes may occur in adult life. 2-5 Global estimates of perinatal deaths showed preeclampsia and eclampsia as been responsible for every 1 in 4 infant deaths especially early newborn deaths. In Nigeria, the perinatal mortality rate from preeclampsia/eclampsia ranges between 8-30% mainly due to low birth weight, prematurity and birth asphyxia. 4-7 Thus, the association of preeclampsia with adverse fetal outcome, increased perinatal morbidity and mortality calls for a more concerted effort towards collaborative care rather than the current practice employed by single specialty obstetric care.1,4-7
The recent review of the millennium development goals where Nigeria was unable to attain the health related goals creates an opportunity for us to revisit our obstetric and neonatal practices both of which were the significant contributors to the failure of lack of progress towards addressing the high childhood and maternal mortality rates in the country.10,11 Focus antenatal care is a concept that has been widely acclaimed for its potential to stratify antenatal obstetric care according to pregnancy risk and thus resulting in better outcome. Preeclampsia/eclampsia been a high risk pregnancy has the greatest potential for benefitting from this concept. Involving the neonatologist as early as possible in the obstetric care of women with preeclampsia/eclampsia will help in mitigating some of the avoidable morbidities and mortality experience by these infants.
In Nigeria, health care delivery is still rudimentary and poorly organized. Neonatal care facilities are few with very limited capacity for neonatal intensive care.9,11,12 Even where this capacity exists, the number of babies that could potentially benefit is few due to space and man power constraints while in most cases the cost will be so prohibitive that the babies who need it may not afford the care.11,12 As a result, early detection of preeclampsia and collaborative care between obstetricians and paediatricians will greatly aid in better antenatal surveillance and thus resulting in better outcome for these babies thereby preventing the high cost and burden of care currently experienced as a result of high burden of low birth weight, prematurity, birth asphyxia and prolong hospital stay4,5.9,11 This forms the basis for the conceptualization of this proposed study on maternal predictors of infant outcomes in preeclampsia/eclampsia. The goal is to examine the average birthweight, gestational age, APGAR score and comorbidities among these infants in order to assess their rate of low birth weight, prematurity, asphyxia and hospital admission in early neonatal period. We will then dichotomize the women based on their infant outcomes and assess how maternal sociodemographic, clinical and biochemical characteristics predict infant outcome. Secondarily, we also aimed to examine if any difference exist in the above outcome measures between those babies exposed antenatally to magnesium sulphate with those that were not exposed.
- Experimental Design and Methods
Study Setting
The Jos University Teaching Hospital is a 500 bed capacity hospital that serves about 8 states within the North central and parts of North eastern Nigeria. The hospital runs daily antenatal clinics with an average of 120 women seen daily out of which 10 new cases are reviewed on each clinic day. It has an annual delivery rate of about 2839 babies with preeclampsia/eclampsia complicating about 15% of those deliveries annually. The delivery room is staffed by a supervising consultant, 2 resident doctors and about 4 nurses per shift while the antenatal clinics are run by consultant obstetricians.
Study population
The study population will consist of pregnant women presenting to JUTH with a diagnosis of preeclampsia or eclampsia. Pre-eclampsia will be defined as systolic blood pressure ≥140 mmHg or diastolic pressure ≥90 mmHg, (or increases of 30 mmHg systolic or 15 mmHg diastolic from the baseline) on at least two occasions six or more hours apart and associated proteinuria that develops from the 20th gestational week in a previously normotensive woman. Eclampsia will be defined as the onset of convulsions described as grand-mal type seizures first appearing before or during labour, or within 48 hours from delivery, and/or coma unrelated to other cerebral conditions in women with pre-eclamptic signs and symptoms.
Study design
This will be a prospective cohort study comparing a sample of women followed up in the antenatal unit of the Jos University Teaching Hospital (JUTH) with a diagnosis of pre-eclampsia with normotensive women for the assessment of their fetal and infant outcome. The sample size is determined using OpenEpi version 3.03a to be 150 based on the estimated effect size of 12.5%, a power of 80%, α level of 0.05 and an attrition rate of 10%.
Maternal selection
Each woman who consented to the study will be enrolled after obtaining informed consent. A self administered questionnaire will be used to obtain socio-demographic and relevant clinical history. In addition, standard methods/protocols for weight and height measurements will be used to obtain her baseline anthropometric parameters. Blood pressure will be measured using the JNC 7 protocol after which a unique identification number will be given to her. Clinical review of each participating pregnant woman will be done at her regular antenatal visits until delivery of the baby. While serum samples will be collected at enrolment and at delivery for biochemical assay of inflammatory biomarker such as placenta derived growth factor, highly sensitive C-reactive protein and procalcitonin.
Infant assessment
At delivery, basic anthropometric data (such as weight, length, head circumference, thoracic circumference) and physiologic parameters (eg APGAR scores) will be obtained from the baby using standard methods/protocols. While cord blood assay for biochemical assay of placenta derived growth factor, highly sensitive C-reactive protein, serum amyloid A, and procalcitonin using commercially available analytic systems will be done. The infant anthropometric measurements will be used in classifying the birth weight according to the WHO classification while APGAR scores will be used to evaluate the presence of birth asphyxia.
Each infant will also undergo a trans-thoracic screening echocardiography using a portable sonosite echocardiographic machine at birth for the assessment of functional and structural cardiac dysfunction. Echocardiograpy will be done because of the relative risk of congenital heart disease such as patent ductis arteriosus in premature and low birthweight infants because of its potential contribution to morbidity and thus outcomes in these infants. Bone density scan to assess bone age and developmental assessment will be done at birth using Dubowitz method. (The Dubowitz method of gestational assessment assesses neuromuscular maturity in newborns). Bone density scan and developmental assessment will help to validate gestational age assessment for the infants especially since health literacy in Nigeria is low with many of the women usually unsure of their dates.
Study outcomes
The primary outcomes of interest will be an adverse neonatal/infant event. An adverse neonatal outcome will be defined as one or more of the following: Birth asphyxia, need for admission to the special care unit, prematurity (a baby born before 37 completed weeks) and low birth weight (baby weighing less than 2500gm).
The secondary outcomes of interest will be infant death occurring in the first 28 days of life. Subset of this outcome such as still birth rate, perinatal and neonatal death rates will also be ascertained. A still birth will be defined as delivery of a baby that died in the uterus after 28 weeks of gestation. An early neonatal death will be defined as any infant death within the first seven days of life. Overall neonatal death will be defined as death of a baby in the first twenty eight days after delivery while perinatal death will be defined as all stillbirths plus early neonatal deaths.
Ethical consideration
Ethical clearance will be obtained from the research and ethics committee of the Jos University Teaching Hospital before the commencement of the study.
Statistical analysis
The baseline characteristics of study subjects will be described using proportions, median, inter-quartile range, mean, standard deviation, frequency and percentage. For comparisons between poor infant outcome group and good infant outcome group, the student’s t test will be used for continuous variables and chi square for categorical data. To identify the sociodemographic, clinical and behavioural predictors independently associated with infant outcome in the poor outcome or good infant outcome groups, univariate and multivariate analyses will be performed using Cox regression analyses. The criterion for significance for all analyses will be set at a P-value of α = 0.5. All statistical analyses will be done with the statistical software package SPSS version 20.
- References
- Vogel JP, Souza JP, Mori R, Morisaki N, Lumbiganon P, Laopaiboon M, Ortiz‐Panozo E, Hernandez B, Pérez‐Cuevas R, Roy M, Mittal S. Maternal complications and perinatal mortality: findings of the World Health Organization Multicountry Survey on Maternal and Newborn Health. BJOG: An International Journal of Obstetrics & Gynaecology. 2014 Mar 1;121(s1):76-88.
- Lorquet S, Prequeux C, Munaut C, Foidart JM. Aetiology and physiopathology of pre-eclampsia and related forms. Acta Clin Belg 2010;65:237-41
- Soydemir F, Kenny L. Hypertension in pregnancy. Current Obstet Gynaecol. 2006;16:315–20.
- Osungbade KO, Ige OK. Public health perspectives of preeclampsia in developing countries: implication for health system strengthening. Journal of Pregnancy. 2011 Apr 4;2011.
- Yakasai IA, Gaya SA. Maternal and fetal outcome in patients with eclampsia at Murtala Muhammad Specialist Hospital Kano, Nigeria. Ann Afr Med 2011;10:305-9.
- Erim DO, Resch SC, Goldie SJ. Assessing health and economic outcomes of interventions to reduce pregnancy-related mortality in Nigeria. BMC Public Health. 2012 Sep 14;12(1):1.
- Oylumlu M, Ozler A, Yildiz A, Oylumlu M, Acet H, Polat N, Soydinc HE, Yuksel M, Ertas F. New inflammatory markers in pre-eclampsia: echocardiographic epicardial fat thickness and neutrophil to lymphocyte ratio. Clinical and Experimental Hypertension. 2014 Nov 1;36(7):503-7.
- Uzan J, Carbonnel M, Piconne O, Asmar R, Ayoubi JM. Pre-eclampsia: pathophysiology, diagnosis, and management. Vascular health and risk management. 2011;7:467.
- Abalos E, Cuesta C, Carroli G, Qureshi Z, Widmer M, Vogel JP, Souza JP. Pre‐eclampsia, eclampsia and adverse maternal and perinatal outcomes: a secondary analysis of the World Health Organization Multicountry Survey on Maternal and Newborn Health. BJOG: An International Journal of Obstetrics & Gynaecology. 2014 Mar 1;121(s1):14-24.
- Jido TA, Yakasai IA. Preeclampsia: a review of the evidence. Annals of African medicine. 2013 Apr 1;12(2):75.
- Olusegun OL, Ibe RT, Micheal IM. Curbing maternal and child mortality: The Nigerian experience. International Journal of Nursing and Midwifery. 2012 Apr 30;4(3):33-9.
- National Population Commission (NPC) [Nigeria] and ICF International. 2014. Nigeria Demographic and Health Survey 2013. Abuja, Nigeria, and Rockville, Maryland, USA: NPC and ICF International.
- Plan for Protection of Human Subjects.
Risks/benefits to participants
This research will be done at minimal risk to the patients. Each procedure will be carefully explained to the care giver while utmost care and decorum will be employed in handling the study subjects. The benefits to the mother-child pair will be a comprehensive clinical and developmental assessment in addition to a detailed cardiovascular screen with a potential for early intervention in addressing any problem detected. All investigations will be at no cost to the subjects.
Method of collecting informed consent
Subjects would be counseled repeatedly during the entire study period. All consenting women will have a specially designed sticker placed on their antenatal records to alert the skilled birth attendants of the need to inform the investigators immediately they come into labour or at any point of delivery.
Baseline socio-demographic information and medical history would be taken. They would also be educated about their rights to be treated with respect, including respect for their decision whether or not they want to be part of the study. Specifically they will be told that their choice of not being in the study will not result in any penalty or loss to any benefit to which they are entitled including their right to seek routine medical care at the centre.
Plans to safeguard the patient’s information
Subjects would be assured of the confidentiality of their personal information. However, they would be made aware that participating in this study implies that they have given permission for their personal information and medical histories to be included in the study results which may be used for teaching, publications or presentation at scientific meetings. All such use will however not include any identifiers that will uncover their identity.
- Project Mentor:
Professor F Bode-Thomas has graciously accepted to supervise and mentor this research process. She is well published and is a Paediatric cardiologist.
- IRB Approval
Ethical clearance will be obtained from the JUTH Human Research Ethics Committee for the study.