Ige Proposal


 

THE INCIDENCE OF CONGENITAL HEART DISEASE IN JOS UNIVERSITY TEACHING HOSPITAL

 

SUPPORT OF TRAINING AND MENTORING IN NIGERIA FOR ACADEMICS

 

DR IGE, OLUKEMI OMOWUMI

 

     

 

 

 

 

PRINCIPAL INVESTIGATOR: OLUKEMI OMOWUMI IGE

Email address: kemidr@hotmail.com

Telephone number: 07034376627

Citi number: 3878925

CO- INVESTIGATOR: CHRISTOPHER SABO YILGWAN

MENTORS: PROF FIDELIA BODE- THOMAS

                      PROF STEPHEN OGUCHE – Citi number: 3709062

DEPARTMENT OF PAEDIATRICS, UNIVERSITY OF JOS

Proposed date of commencement: January 2016

 

ABSTRACT

BACKGROUND

Congenital heart disease (CHD) refers to the presence of a structural abnormality of the heart and/ or its great vessels that is present at birth.[1]  It is the most common type of birth defect and accounts for nearly one-third of all major congenital malformations.[2],[3] CHD are also among the most severe and life-threatening birth defects and contributes to infant and childhood morbidity and mortality including still births.[4]

The only study on the incidence of CHD in Nigeria so far is that reported by Gupta and Antia in 1967.[5]  The true incidence of CHD in the country is likely to be much higher than the reported 3.5 per 1000 births in Guptia’s study in view of the recent technical advancements in echocardiography (echo) which were not present at that time.

This study will provide a better picture of the incidence and associated risk factors of CHD such as diabetes mellitus and maternal smoking in a Nigerian city. It will provide statistics on maternal and child morbidity and mortality and could also serve as baseline data for the establishment of an institutional registry for CHD.

PATIENTS AND METHODS

The study will be carried out at the Jos University Teaching Hospital (JUTH), in Jos, Plateau State. It is an open cohort study. All consenting parents will have their babies enrolled in the study. These babies will be screened for CHD and will be closely followed up for at least one year. Babies with CHD or other disease conditions will have all their therapies and other interventions documented.

Sample size determination

The sample size was determined using OpenEpi version 3.30a as 332 babies at 95% confidence interval and a prevalence rate of 50%. Using a 10% attrition rate, the proposed sample size will be 365 babies.

Data collection

Using a pre-designed proforma, all enrolled babies will have their demographic information including a detailed home address, relevant family, maternal medical history and possible risk factors exposure recorded. The latter will include: history of heart disease and CM in first degree relatives, maternal drug and hormone ingestion including alcohol and tobacco use, maternal diabetes mellitus, febrile illnesses and skin rashes during early pregnancy. Others will cover radiation and other possible teratogens exposure.

A detailed newborn examination, including a complete cardiovascular system clinical examination and pulse oximetry will be performed on all live-born babies recruited into the study within 24 hours of delivery. Other obvious congenital abnormalities such as hydrocephalus, spina bifida and imperforate anus among others will be noted.

All live-born babies will have an electrocardiogram (ECG) done and also undergo an echocardiogram. This will be done as much as possible before discharge from the hospital or at most scheduled within the 1st week of life. All information obtained will be recorded on a case record form.

  • The difficulty performing a postmortem in stillbirths within the shortest available time due to logistic reasons led to the decision to recruit only  livebiths.

Follow- up

All babies enrolled will be followed-up for a period of one year. Follow up will be by telephone conversation and home visits if healthy or in the hospital if baby on admission or has a routine clinic visit at 1 week, one month, 6 months and 1 year. We will assess and record the state of health of each baby at each point in time.

Ethical consideration

Ethical clearance for this study has been obtained from the research and ethics committee of the Jos University Teaching Hospital.

Statistical analysis

Data will be entered into and analyzed using the Epi info version 7. Frequency table will be used to present qualitative data such age group and socio-economic status of the parents, sex of the babies, presence and pattern of congenital CHD and possible risk factors for CHD. Quantitative data such age of the parents, gestational age of the babies at birth and parents’ monthly income will be presented using mean ± standard deviation. Chi square statistical test with Bonferroni  correction where appropriate will be used to determine the relationship between characteristics of the babies/ parents and the presence of CHD as well as the contribution of CHD to mortality and morbidity among the babies. Multivariate logistic regression will also be employed to identify risk factors predicting CHD in this study. Confidence interval for this study will be set at 95% with a p value ≤ 0.05 considered statistically significant.

BUDGET

PROPOSED BUDGET FOR THE STUDY

ITEM                     QUANTITY    FREQUENCY  UNIT COST (N)   TOTAL COST(N)

 

 

 

Personnel

  Research Assistant                1             12months          15,000                180,000

  (Will be sourced separately)

Materials and Methods

  ECG                                      365         1/ baby              500                     182,500

  (Will be sourced separately) 

  Echo                                      365         1/ baby              3,000                 1095,000

  Telephone calls                      365         4/ baby              75                       109,500  

  Home visits                           365         4/ baby              180                     262,000                          

GRAND TOTAL                                                                                   1,829,000

 

GRAND TOTAL excluding resources for the research assistant and ECG which will be sourced separately, the total amount needed will be N1, 466,500.00 (One million, four hundred and sixty six thousand and five hundred Naira Only)

BUDGET JUSTIFICATION

Principal Investigator: Ige Olukemi Omowumi

Project title: Incidence of Congenital Heart Disease in Nigerian Children

Personnel:

Mentors (Prof. Stephen Oguche, Prof Fidelia Bode- Thomas): Will provide scientific support and supervision throughout the duration of the research. No salary requested.

Dr Olukemi Ige: Will oversee all aspects of the research - Protocol design, recruitment, data collection, analysis and interpretation of results. No salary requested

Co- Investigators (Dr Christopher Yilgwan, Dr Esin): Will be involved in recruitment, data collection, analysis and interpretation of results. No salary requested

Research Assistant: Will coordinate research logistics and obtaining consent. He/ she will also be involved in making telephone calls and organizing home visits. Resources for the research assistant will be sourced separately.

Electrocardiography:

All babies recruited into the study will have an electrocardiography (ECG) done which will help to determine the presence of congenital heart block and other abnormalities that may occur in babies with CHD.  Resources for this will be sourced separately.

Echocardiography:

A detailed echo will be performed on all babies recruited into the study.

Telephone calls:

This would be used to follow- up these babies at 1 week, 1 month, 6 months and 1 year with each call lasting about 5 minutes each.

Home visits:

All babies will also be visited at home to verify information obtained during the telephone conversation, or to obtain information from parents/ caregivers who could not be reached on the phone.

Publication costs: Research findings will be published in a peer- reviewed journal

Travel costs: Research findings will be presented at a conference

 

 

 

PROJECT NARRATIVE

The availability of funds to conduct this research will provide information about the current incidence and spectrum of congenital heart disease, the possible risk factors and the presence of associated obvious congenital anomalies. It would also detect the contribution of CHD to infant mortality and would be a basis for future research on CHD including its prevention and management.

RESEARCH PLAN

The specific objectives of the study are:

  1. To determine the incidence and pattern of CHD among babies born in JUTH, Jos, Nigeria.
  2. To identify risk factors for CHD in JUTH, Jos.
  3. To determine the prevalence of other obvious congenital malformations
  4.  To determine the contribution of CHD to infant morbidity and mortality in JUTH, Jos.

 

BACKGROUND AND SIGNIFICANCE

Congenital heart disease (CHD) refers to the presence of a structural abnormality of the heart and/ or its great vessels that is present at birth.[1]  It is the most common type of birth defect and accounts for nearly one-third of all major congenital malformations.2,3 CHD are also among the most severe and life-threatening birth defects and is an important cause of childhood morbidity and mortality including sill births.4 The reported incidence rate of CHD in developed countries has steadily increased from about 4-5 per1000 live births in the 1950’s to as much as 50-75 per 1000 more recently due to the availability of echocardiography presently which has greatly improved diagnosis. 4,5 Nearly half of deaths as a result of CHD occurs in the first of life. 5

There is a paucity of data on the incidence of CHD in most developing countries. Estimates of the numbers of children born with CHD in these countries have generally been extrapolated from older studies in developed countries. 6, 7 It is thought that the true burden of CHD may actually be much higher in developing countries due to factors such as higher birth rates and higher prevalence of risk factors for CHD such as the higher proportion of older parents, maternal diabetes mellitus, smoking, malnutrition and infections among others.8

The only study on the incidence of CHD in Nigeria so far is that reported by Gupta and Antia in 1967.[1]  The true incidence of CHD in the country is likely to be much higher than the reported 3.5 per 1000 births in Guptia’s study in view of the recent technical advancements which were not present at the time of the study.

This study is therefore necessary as it will provide a better picture of the incidence and associated risk factors of CHD in a Nigerian city. It will provide statistics on maternal and child morbidity and mortality and could also serve as baseline data for the establishment of an institutional registry for CHD.

EXPERIMENTAL DESIGN AND METHODS

Setting

The study will be carried out at the Jos University Teaching Hospital (JUTH), in Jos, Plateau State with an average of 200 deliveries occurring every month.

Study design and Study population.

This will be a cohort study. All consenting mothers or fathers will have their babies enrolled in the study. These babies will be screened for CHD and will be closely followed up for 12 months. Babies with CHD or other disease conditions will have all their therapies and other interventions including mortality over this period documented.

Sample size determination

The sample size was determined using OpenEpi version 3.30a as 332 babies at 95% confidence interval and a prevalence rate of 50%. Using a 10% attrition rate, the proposed sample size will be 365 babies.

Babies will be randomly selected over a period of 3 months and will be enrolled into the study. Informed and written consent will be obtained from the parents.

Data collection

Using a pre-designed proforma, all enrolled babies will have their demographic information including a detailed home address, relevant family, maternal medical history and possible risk factors exposure recorded. The latter will include: history of heart disease and CM in first degree relatives, maternal drug and hormone ingestion including alcohol and tobacco use, maternal diabetes mellitus, febrile illnesses and skin rashes during early pregnancy. Others will cover radiation and other possible teratogens exposure.

Each baby will be fully examined and the findings recorded in the pro-forma. A detailed newborn examination, including a complete cardiovascular system clinical examination and pulse oximetry will be performed on all live-born infants within 24 hours of delivery. Other obvious congenital abnormalities such as hydrocephalus, spina bifida and imperforate anus among others will be noted.

All live-born babies will have an electrocardiogram (ECG) done and also undergo an echocardiogram. This will be done as much as possible before discharge from the hospital or at most scheduled within the 1st week of life. 

Follow- up

All babies enrolled will be followed-up for a year.

Infants who were found to be normal at birth will be followed up by telephone and/ or home visits to ascertain the baby’s state of health (healthy, sick or dead) at 1 week, one month, six months and one year. Mothers will be encouraged to regularly attend well-child clinic and to report in hospital or contact any of the study physicians if their babies are sick at any time. Sick infants will be asked to report at the Emergency Paediatric Unit for a clinical examination to determine the cause of illness and to render the appropriate treatment. A verbal autopsy will be carried out with respect to those who are reported to have died.

Home visits will also be conducted to verify information obtained during telephone conversations or obtain access to parents/ care givers of these infants who could not be reached on the telephone.

Other infants with any disease condition will be followed up at the appropriate specialty clinic in JUTH. Their state of health at 1 week, 1 month and 6 months of age will be ascertained either at the clinic, telephone calls and/ or home visits. Reminders will be sent to parents/ caregivers to ensure that the babies are seen in their respective clinics at the appropriate time.

Statistical analysis

Data will be entered into and analyzed using the Epi info version 7. Frequency table will be used to present qualitative data such age group of the parents, socio-economic status of the parents, sex of the babies, presence and pattern of congenital CHD and possible risk factors for CHD. Quantitative data such age of the parents, gestational age of the babies at birth and parents’ monthly income will be presented using mean ± standard deviation. Chi square statistical test with Bonferroni  correction where appropriate will be used to determine the relationship between characteristics of the babies/ parents and the presence of CHD as well as the contribution of CHD to mortality and morbidity among the babies. Multivariate logistic regression will also be employed to identify risk factors predicting CHD in this study. Confidence interval for this study will be set at 95% with a p value ≤ 0.05 considered statistically significant.

Plan for Protection of Human Subjects:

The study will involve no risk to the babies. Babies with CHD or other disease conditions will be referred to the Paediatric cardiology clinic or appropriate specialist clinics in JUTH for further evaluation, treatment and follow- up if necessary. The study will be beneficial to babies with various disease conditions since they will be diagnosed early and appropriate treatment instituted on time. Written and informed consent will be obtained from the baby’s primary care giver prior to administration of the questionnaires, examination, ECG and echo. The information of the children will be safeguarded by entering their data without identifiers while the questionnaires will be kept locked up until two years after completion of the study.

Inclusion of women, minorities and children:

Children will be the subjects in this study. The study will however not expose the children to any risk. Informed and written consent will also be obtained from the parents/ caregiver.

Vertebrate animals: Not applicable

Biohazards: Not applicable

BENEFITS

To the baby, the study will determine the presence or otherwise of CHD and other obvious congenital malformations. It will also identify other disease conditions as a result of the follow up. The risk factors for CHD will also be ascertained to help reduce the incidence of CHD in other unborn family members. To the medical personnel, the study will help improve our knowledge on the incidence, risk factors and contribution of CHD to infant mortality.

RETENTION PLAN

Parents/ caregivers will be well informed about the study and what it entails before consent is sought from them. Follow up visits will be made convenient for them because we will carry out telephone calls and home visits at no expense to them. Hence, phone numbers obtained will be verified and a detailed home address obtained for each baby recruited into the study. In the event of a strike, parents/ caregivers will be informed of an alternative venue for echocardiography or admissions if needed.

PROPOSED TIMELINE FOR “THE INCIDENCE OF CONGENITAL HEART DISEASE IN JOS UNIVERSITY TEACHING HOSPITAL”

 

April / May

June/ July

Aug/ Sep

Oct/ Nov

Dec/ Jan

Feb/ March

April/ May

June/ July

Aug/ Sep

Study planning

_______

 

 

 

 

 

 

 

 

Recruiting babies

______

_____

 

 

 

 

 

 

 

Follow up

_____

_____

_____

_____

_____

_____

_____

_____

 

 

Progress report

 

 

 

 

_____

 

 

 

 

Data organization

 

 

 

 

 

 

 

_____

 

Preliminary analysis

 

 

 

 

 

 

 

_____

 

Completion of statistical analysis

 

 

 

 

 

 

 

 

_____

Final report/ Publications

 

 

 

 

 

 

 

 

_____

 

REFERENCES

 

[1] . Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol 2002; 39: 1890-1900.

[2] . Botto LD, Correa A, Erickson JD. Racial and temporal variations in the prevalence of heart defects. Pediatrics 2001; 107: E32.

[3] . Bannerman CH, Mahalu W. Congenital heart disease in Zimbabwean children. Ann Trop Paediatr 1998; 18: 5-12.

[4] . Rosamond W, Flegal K, Friday G, Furie K, Go A, Greenlund K, et al, for the American Heart Association Statistics Committee and Stroke Statistics Subcommitte. Heart disease and stroke statistics – 2007 update. Circulation 2007; 115: e69 – e171.

[5] Gupta B, Antia AU. The incidence of congenital heart disease in Nigerian children. Br Heart J 1967; 29: 906 – 909.

8 Howson C, Christianson A, Modell B. Controlling birth defects: reducing the hidden toll of dying and disabled children in low-income countries. In: Disease Control Priorities Project 2008. Available from: http://www.dcp2.org. Accessed 22nd July, 2015.

PERSONAL INFORMATION PAGE

MENTOR

  1. NAME: PROF STEPHEN OGUCHE
  2. DEPARTMENTAL CONTACT ADDRESS: DEPARTMENT OF PAEDIATRICS, FACULTY OF MEDICAL SCIENCES, UNIVERSITY OF JOS, JOS, PLATEAU STATE
  3. EMAIL: soguche2001@yahoo.com
  4. PHONE NUMBERS: 08036284906, 08101646884
  5. MEPIN CITI NUMBER: 3709062

MENTOR

  1. NAME: PROF FIDELIA BODE- THOMAS
  2. DEPARTMENTAL CONTACT ADDRESS: DEPARTMENT OF PAEDIATRICS, FACULTY OF MEDICAL SCIENCES, UNIVERSITY OF JOS, JOS, PLATEAU STATE
  3. EMAIL: bodefide@yahoo.com
  4. PHONE NUMBERS: 08033298152

MENTEE

  1. NAME: OLUKEMI OMOWUMI IGE
  2. DEPARTMENTAL CONTACT ADDRESS: DEPARTMENT OF PAEDIATRICS, FACULTY OF MEDICAL SCIENCES, UNIVERSITY OF JOS, JOS, PLATEAU STATE
  3. EMAIL: kemidr@hotmail.com, kemidr1@gmail.com
  4. PHONE NUMBERS: 07034376627
  5. MEPIN CITI NUMBER: 3878925