RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BENGALURU, KARNATAKA

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1) / NAME OF THE CANDIDATE
AND ADDRESS / Ms. Sumitha Sibi P.J,
First year M.Sc Nursing,
VSS College Of Nursing,
Nagadevanahalli,Kengeri
Bengaluru-560060
2) / NAME OF THE INSTITUTION / VSS College Of Nursing,
Bengaluru
3) / COURSE OF THE STUDY AND SUBJECT / First year M.Sc Nursing
Pediatric Nursing
4) / DATE OF ADMISSION TO THE COURSE / 10-06-2011
5) / NAME OF THE TOPIC / “A study to assess the effectiveness of Structured Teaching Programme regarding the knowledge on pneumococcal vaccination among mothers of underfive children attending the immunization clinic in a selected pediatric hospital, Bengaluru”

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6) BRIEF RESUME OF THE INTENDED WORK

INTRODUCTION

“Immunizers should act without delay and reach out to the parents of eligible children so children have the opportunity to be vaccinated with the updated version”-

Robert Booy

Pneumococcal infections are the leading cause of death throughout the world and pneumococci is considered as a major cause of pneumonia,bacteremia,meningitis and otitis media.Among pneumococcal infections, pneumonia is the single largest cause of death in children worldwide.Pneumonia kills an estimated 1.5million children under five years of age annually –more than AIDS,Malaria and TB combined.12The most common form of pneumococcal infections is bacteremic pneumococcal pneumonia in which, the highest incidence is associated with both extremes of age ie, less than 2years of age and more than 65 years of age.Pneumonia accounts for about 18% of underfive children deaths anually including deaths during neonatal period itself.Pneumonia affects children and families everywhere but it is most prevalent in South Asia and Sub Saharan Africa.It is estimated that more than 90% of underfive mortality due to pneumonia occur in the developing countries.26

Pneumococcal bacteria attacks different parts of the body,when it attacks the the lung, it results in pneumonia;it causes bacteremia in blood and meningitis in brain.

Underfive children prone to get pneumococcal infections from the community.3

Pneumococcal vaccination or prevenar provides protection to children against most of the bacteria that cause pneumococcal pneumonia and also other Pneumococcal diseases.The latest version of pneumococcal vaccination is pneumococcal Polysaccharide Vaccine ie, PPSV 23 or Pneumovax 23.It is advised for children above 2 years and adults above 65 years of age.For children below 2 years of age, only a 13-valent pneumococcal conjugate vaccine is advised.It is recommended for the children who are at special risks such as having sickle cell diseases,kidney diseases , Diabetes, leakage of CSF, heart diseases, lung diseases, asplenia etc.3 Pneumovax 23 is a sterile,liquid vaccine for IM or SC injection that has highly purified capsular polysaccharides from 23 most prevalent or invasive pneumococcal types.Each 0.5mL dose of vaccine induces specific antibodies that enhances phagocytosis,opsonization and killing of pneumococci by phagocytic cells.17

Indian Academy of Pediatrics(IAP) recommended pneumococcal conjugate vaccine (PCV) as routine vaccine in pediatrics which is to be given during 6th week,10th week,14th week and during 15th month of infant’s life.The vaccine is safe and it works giving results that could protect individual from bacteria upto 5-10years3.The vaccine can cause the most common side effects like the injection site soreness, erythema, warmth, swelling and fever less than or equal to 102 degree farenheit.Pneumovax 23 is supplied as one 5-dose vial of liquid vaccine,color coded with a purple cap and stripe on the vial labels and cartons.17The storage of this vaccine both opened and unopened vials is at 2 to 8 degree Celsius and it should be discarded after the expiration date.In U.S.A,a conjugate vaccine called PCV 7 is recommended for all children aged 2-23 months and for risk children aged 24-54 months from the year 2000 onwards.4 Similarly, UK government introduced the Pneumococcal conjugate vaccine in children of age 2,4 and 13 months from February 2006 onwards.In South Africa, vaccination with Pneumovax 23 has reported 76-92% protective efficacy. 31

Currently, pneumococcal vaccination is mostly used in routine immunization programme of developed countries.India also has the chance to access pneumococcal vaccination in National Immunization Programme with financial support from GAVI which comes under WHO21.During 2009,the Global Action Plan for the Prevention and control of Pneumonia(GAPP) aimed to accelerate pneumonia control with a combination of interventions to protect,prevent and to treat pneumonia in children by means of breast feeding,handwashing,reducing indoor pollution.26The other control measures include timely pneumococcal vaccination and to treat pneumonia by ensuring that every sick child gets right kind of either from a community based health worker or in a health facility.15 The health care provider should determine the health status of child and previous vaccination history.It is also necessary to enquire about the reaction of the child to previous pneumococcal vaccination.1

6.1 NEED FOR THE STUDY

Pneumococcal infections are the leading cause of childhood mortality and morbidity globally and it causes an estimated 0.7 to 1 million death among under five children.The pneumococcal infections like pneumonia,bacteremia,meningitis are more life threatening conditions.A Streptococcal pneumoniae, that causes pneumonia which can easily spread in community and cause Invasive Pneumococcal Diseases (IPD) in children and older adults.Pneumonia is the leading killer of children in India. A recent UNICEF publication estimated that 410,000 children less than five year age group die of pneumonia in India21.Initiative of Vaccine Research during 2009 revealed that in South India,50% of infants have been colonized by S.pneumoniae by 2 months of age and 80% are carriers by the age of 6 months.27

Progress in reducing mortality from pneumonia among underfive is relatively slow in many parts of India even newer conjugate vaccines are introduced to enhance the immune responses in children.The high morbidity and mortality rates resulting from the pneumococcal infections and the increasing of multi-drug resistant strains have emphasized the urgent need for the implementation of effective pneumococcal vaccines among children.Moreover the prevalence of pneumonia is more in South Asia and Sub Saharan Africa.7Unfortunately,the pneumococcal vaccination is not so popular among parents of underfive children due to the lack of public awareness of the disease. Dr Musa,who is a pediatrician working in Damansara Specialist Hospital Malaysia, stressed on the important role of parents in disseminating information to the public.19

Pneumococcus bacteria are becoming increasingly resistant to antibiotic such as penicillin and others.The effective treatment of pneumococcal diseases can prevent mortality but the higher rates of bacterial resistance caused concern that only secondary treatment of pneumococcal diseases are not enough.According to UNICEF 2007, India has the highest pneumococcal deaths among children.About 69% of children with suspected pneumonia are taken to a health facility and about 13% are treated with antibiotics.14 Pneumococcal Vaccines Accelerated Development and Introduction Plan (Pneumo ADIP)is a programme to accelerate the evaluation and access to pneumococcal vaccines in developing countries. Pneumo ADIP aims to save 5.4 million children by 2030.21

An experimental study was conducted in Gambia based on WHO’s trials to assess the efficacy of nine-valent pneumococcal conjugate against pneumonia and Invasive Pneumococcal Diseases(IPD).The sample size was 17,347 children of age between 6-51weeks.A randomized, control double-bind trial of pneumococcal conjugate study was done. There were 8719 children in the control group and they received only DPT Hemophilus Influenza serotype b vaccine. The experimental group had 8718 children, who received pneumococcal conjugate vaccine. The results indicated that pneumococcal conjugate vaccine was proven to be effective against pneumonia and IPD and also it could improve child survival. This study concluded that there was an urgent need for pneumococcal vaccine to be made available as soon as possible to African infants.10

Coles CL et al(2001) conducted a study among 464 newborns from a rural area in South India with endemic Vitamin A deficiency. The objective was to assess the pneumococcal nasopharyngeal colonization among the infants. The method was to collect the nasopharyngeal specimens from each infants at ages of 2,4 and 6 months. It was estimated that maternal night blindness increased the risk for colonization three-fold among infants below six months. The study concluded that South Indian infants experience a high rate of pneumococcal carriage during the first six months, which may partially explain their increased risk for pneumonia. The study also gave emphasis on the need for pneumococcal vaccination among infants in South India.7

A survey was conducted in Malaysia, during March 2007-May 2007 to assess and evaluate the awareness of pneumococcal vaccination in infants and children among their parents. The objective of the study was to educate parents about the importance of vaccination. A prospective questionnaire consisted of 167 questions were used for the analysis and parents were regularly councelled on pneumococcal vaccination.Following councelling,questionnaires were distributed to them.The results showed that majority had secondary education(mothers:69.5%, fathers:71.9%) followed by tertiary education (mothers:21.6%, fathers:20.4%).This survey concluded that the awareness on pneumococcal vaccination was still lacking among parents.Hence, through a well initiated awareness programme and improvised councelling techniques can improve the knowledge and perception of parents on pneumococcal vaccination.18

In India,the careful population based studies to estimate the incidence of Invasive Pneumococcal Diseases are lacking for WHO to estimate the current statistics rates.Based on the available data, WHO estimates that serotypes in 7-valent vaccine accounts for approximately 52% of severe pneumococcal diseases in underfive children.WHO has included India in criteria for countries where pneumococcal vaccination is needed to be introduced and implemented urgently.21

Pneumococcal infections are considered to be a burning and challenging issues for nursing professionals to tackle with the problems.It is very essential that the mothers of underfive children must be taught regarding the benefits of vaccination that can help children to be protected from such infections as they are prone to get pneumonia from community or possibly after a cold or flu.Health care provider can teach parents about the color and labeling of the vaccine vial inorder to protect the child from getting vaccines beyond the expiry date and also wrong vaccine. Parents of underfive children should be informed that if the child has a community acquired pneumonia, pneumococcal vaccination can be taken to prevent development of serious life threatening complications.1Mothers should be informed that the Pneumococcal vaccination is only a help to reduce the disease burden but still it’s the individual

responsibility to take care of children by providing right food and better management of indoor pollution etc2.

REVIEW OF LITERATURE

The primary purpose of reviewing relevant literature is to get broad background knowledge and understanding of the information that is available related to the researcher’s problem of interest, Polit and Hungler(1999)

According to Polit and Hungler(1999),researchers almost never conduct a study in an intellectual vacuum ,their studies are undertaken within the context on an existing base of knowledge.

Andree Hest et al (2000) conducted a study in US to assess the efficacy of 7-valent pneumococcal vaccine in 37,000 children of age group 3-36 months.A large Kaiser-based random controlled trial was the method used by the researchers.This study revealed the results such as 97.4% efficacy was shown by the vaccine against the invasive pneumococcal diseases(IPD) in fully vaccinated children(including the booster) and 89.1% efficacy overall,after the primary series(2,4,6 months of vaccination).This study also recommended that 4 doses should be given at2,4,6 and 12-15 months of age for the children upto two years of age.6

Mariapava et al(2008) conducted a survey to assess the efficacy of pneumococcal vaccination in healthy children less than 24 months.The survey was supported by a research grant from second university of Naples(Naples,Italy).The objective of the survey was a meta-analysis of the published data from trials on pneumococcal conjugate vaccine.This was done inorder to determine the efficacy of pneumococcal vaccination in reducing the incidence of IPD by Streptococcal pneumoniae, pneumonia and acute otitis media in healthy children less than 24 months.The method used by researchers was a systematic search of literatures to compare the protective efficacy of pneumococcal conjugate vaccine.The informations were extracted from the literatures using a standardized protocol. The efficacy in the

reduction of IPD was about 89% and to prevent otitis media was 55%.Thus the researchers concluded that the pneumococcal conjugate vaccines produce a significant effect in prevention of IPD.This survey created a tremendous impact on the health of infants in developed and industrialized countries.16

An open-label study was conducted by Frenck R Jr(2011) in U.S to assess the immunogenecity and safety of 13valent pneumococcal conjugate vaccine among underfive children who were previously immunized with a 7valent pneumococcal conjugate vaccine.Children between 15months to 2years of age were included in group1 and they received two doses of PCV13.Children between 2years and 5years were included in group2 who were received one dose antibodies against the antigens in PCV13. A total of 284 children were included in which group1 had 109 subjects and group2 had 175 subjects.The blood samples from these children were taken and tested before vaccination and one month after the final dose.The results showed that anti-pneumococcal immunoglobulin G geometric mean fold rised from 2 to 19 fold for the PCV7 serotypes and about 2 to 124 fold for the additional 6 serotypes.The study concluded that PCV13 was safe and immunogenic when given to children who had previously received PCV7 and it can be used for supplemental vaccination to provide additional protection against six additional serotypes.11

Nathron et al(2010) conducted a comparative study in UK to assess the cost effectiveness of pediatric pneumococcal conjugate vaccines in accordance with WHO’s guide for economic evaluation of immunization programmes. In this study the researchers used 3 cost effectiveness modeling tools. There were 2 cohort based(ie,Pan American Health Organization{PAHO};Provac Initiative Trivac and PneumoADIP) and one population based model(ie,GlaxoSmithkline’s SUPREMES).All the tools were critically analysed with WHO’s guidelines and the result was that the cohort modeling produced the similar incremental costs and health outcomes and also incremental cost effectiveness ratios.This study also provided guidelines for further clinical and epidemiological research that can be adopted by different countries to scale-up vaccination programmes.20

A study was conducted in Philadelphia during 2010 to assess the immunogenecity and safety of PCV 13 in infants and toddlers.The study compared the immunogenicity and safety of PCV 13 with PCV7.The vaccine PCV 7 has seven serotypes and they are 4,6B,9V,14,18C,19F and 23F.where as PCV 13 has PCV 7 serotypes plus 1,3,5,6A,7F,and 19A.After comparing the immunogenecity and safety,the study concluded that PCV 13 will be as effective as PCV 7 in the prevention of pneumococcal diseases caused by the 7 serotypes as well as it could provide expanded protection against the 6 additional serotypes also.24