National Consultation on Childhood ARI Case Management -Translating Research to Policy and Program- 541

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Proceedings Report

National Consultation onChildhood ARI Case Management:

Translating Research to Policy and Program





Proceedings Report

New DelhiFebruary 25, 2009

National Consultation on

Childhood ARI Case Management: Translating Research to

Policy and Program



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iii

PREFACE

The burden of childhood pneumonia, particularly in India, is undeniably and unacceptably

high. Preventing children from contracting pneumonia is essential for reducing child deaths. Key

prevention measures include promoting exclusive breastfeeding and appropriate complementary

feeding, improving immunization rates, reducing indoor air pollution, etc. Recognition of the

signs and symptoms of pneumonia at the peripheral level, coupled with an equitable and timely

access to a full-course of appropriate antibiotic therapy are life-saving measures. Because

pneumonia kills more children than any other illness, any effort to improve overall child survival

must address the reduction of pneumonia-related death toll on a priority basis.

Globally, and at the national level, a number of research studies are yielding evidence for

improving the case management of childhood acute respiratory infections. This report

summarizes the discussions from a technical consultation organized by IndiaCLEN, with support

from USAID’s MCH-STAR initiative to share the latest evidence on ARI case management so as to

inform program and policy. The technical consultation draws upon the collective technical and

programmatic wisdom of researchers, policymakers, program managers and academics to review

the available research findings in light of the existing policy framework and technical guidelines.

USAID/India and MCH-STAR are committed to supporting efforts that contribute to evidence-

based policy development and dialogue. We hope that the discussions and conclusions from

this meeting will play a useful role in identifying a research agenda for the country on ARI case

management. We also hope that this consultation will facilitate the development of a coalition to

play a sustained leadership role through research and dialogue for reducing pneumonia-related

deaths among children in our country.

Dr. Rajiv Tandon

USAID/India





v

Acronyms

I. Background 6

II. Proceedings 7

Introductory Session 7

Presentations: Evidence from Global and National Research on Childhood ARI 7

Pneumonia Case Management Guidelines: Evidence from Multi-centric Studies,Dr. Ashok Patwari, Boston University 8

Preventing Severe Bacterial Pneumonia in South Asian Region,

Dr. Kurien Thomas, Christian Medical College, Vellore 9

Advances on the Treatment of Non Severe Pneumonia (NSP),

Dr. Shally Awasthi, King George’s Medical University, Lucknow 11

Care Seeking Behavior of Mothers: Findings from the IMNCI Baseline

Assessment of Childhood Morbidity and Mortality in Selected Districts in India,

Dr. Narendra Kumar Arora, IndiaCLEN, New Delhi 12

Panel Discussion: Translating Research Finding to Policy and Program 14

1. Possible Evidences that Need to be Incorporated into the Program 14

2. Issues Related to ARI Case Management 14

3. Role of ASHA in ARI Case Management 15

4. Role of the Indian Academy of Pediatrics (IAP) in Improving Treatment of

Pneumonia 16

5. Operations Research Areas and the Pathways to Plug Evidence Gaps 16

III. Next Steps on Taking the Recommendations Forward 17

Annex 1

IV. Agenda 18

Annex 2

V. Participants

Contents



vi

CEU Clinical Epidemiology Network

CSSM Child Survival and Safe Motherhood Programme

Hib Haemophilus influenzae Type B (vaccine)

IAP Indian Academy of Pediatrics

IndiaCLEN India Clinical Epidemiology Network

IPEN IndiaCLEN Program Evaluation Network

ISCAP IndiaCLEN Short Course Amoxicillin Therapy for Pneumonia

MDGs Millennium Development Goals

NNF National Neonatology Forum

NSP Non-severe pneumonia

UIP Universal Immunization Programme

IMNCI Integrated Management of Neonatal and Childhood Illnesses

USAID United States Agency for International Development

WHO World Health Organization

UNICEF United Nations Children’s Fund

MCH-STAR Maternal Child Health Sustainable Technical Assistanceand Research Initiative

APPIS Amoxicillin Penicillin Pneumonia International Study

NO-SHOTS New Outpatient Short- Course Home Oral Therapy

for Severe Pneumonia

SPEAR Severe Pneumonia Evaluation Antimicrobial Research

SAPNA South Asian Pneumococcal Alliance

IBIS Invasive Bacterial Infections Surveillance

EAG Empowered Action GroupCIHD Centre for International Health and Development

ANM Auxiliary Nurse Midwife

AWW Anganwadi Worker

RCH Reproductive and Child Health

ASHA Accredited Social Health Activist

Acronyms



1

World over, pneumonia kills more children

than AIDS, malaria and measles combined

together, states a report ̀ Pneumonia – The

Forgotten Killer of Children,’ brought out

by the United Nations Children’s Fund

(UNICEF) and World Health Organization

(WHO). The incidence in this age group is six

times higher in developing countries (0.29

episodes per child per year) as compared to

the developed countries (0.05 episodes per

child per year). This translates into about 156

million new episodes each year worldwide,

of which 151 million episodes are in the

developing world. India ranks first in the list,

with around 43 million cases followed by

China (21 million) and Pakistan (10 million)1.

However, of all the cases, only around 7–13%

are severe enough to be life-threatening and

require hospitalization. Substantial evidence

also reveals that the leading risk factors

contributing to pneumonia incidence are lack

of exclusive breastfeeding, undernutrition,

indoor air pollution, low birth weight,

crowding and lack of measles immunization.

While estimates say that pneumonia has

been the single leading cause of childhood

mortality, there is conflicting evidence for

effective childhood acute respiratory infection

(ARI) case management, pertaining to large

differences in case definition of pneumonia

between studies, low specificity of verbal

autopsies in community-based studies,

difficulties in distinguishing pneumonia from

I. Background

sepsis in neonates, and the co-existence of

several morbidities leading to a single death,

etc.

In India, ARIs contribute to approximately

40% of all childhood illnesses in India, and

approximately 30% of all childhood deaths.

A number of research studies and pilots

have been conducted or are underway that

can provide strong scientific evidence for

the modification and improvement of case

management of ARIs in children, and thereby

save children’s lives. The India Clinical

Epidemiology Network (IndiaCLEN), with

assistance from USAID’s Maternal and Child

Health Sustainable Technical Assistance and

Research (MCH-STAR) Initiative, organized

a National Consultation on Childhood ARI

Management: Translating Research into

Policy and Programme, in Delhi on February

25, 2009 to deliberate on the latest policy-

relevant evidence on childhood ARI in India

and globally.

The objectives of the national consultation

were:

• To share the latest research findings

pertaining to ARI case management

• To identify and build consensus on

specific research findings with policy and

program implications

• To develop a roadmap for incorporating

specific research findings into the policy

framework.

1 Rudan I, Boschi-Pinto C, Biloglav Z, Mulholland K, Campbell H. Epidemiology and etiology of childhood pneumonia. Bull World

Health Organ. 2008;86:408–16





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II. Proceedings

Introductory Session

The consultation began with a welcome

note by Dr. Kurien Thomas, President,

IndiaCLEN. He noted the wide participation

at the meeting, representing a range of

stakeholders from the multilateral agencies

(WHO, UNICEF), bilateral agencies and

development partners (USAID, DFID,

and others), academics and researchers

representing a number of medical colleges

and research institutions (ICMR, AIIMS, CMC,

LHMC, UCMS, MAMC, Safdarjung Hospital,

and others), representatives from professional

associations (IAP, NNF) and Government

(Government of India, Government of

Uttar Pradesh).

Dr. Kurien, in his opening speech, reiterated

that the burden of pneumonia2 worldwide

is estimated at 156 million cases per year,

of which 151 million cases occur in thedeveloping world. Half of these cases are in

India. Of all cases, 7-13% are severe and life

threatening, contributing to nearly 19% of all

deaths in children below five years of age. He

summarized that there is an urgent need to

evaluate global and Indian evidence for case

management of ARIs, which could help in

revisiting existing national policies.

Presentations: Evidence from Globaland National Research on Childhood

ARI

Dr. Rajiv Tandon, Division Chief, Maternal,

Child Health and Nutrition, and Urban

Health, USAID/India, moderator of the

session, congratulated this effort of reviewing

research evidence at this juncture. He

remarked that though there is insufficient

evidence from India to conclusively

2 Rudan I, Boschi-Pinto C, Biloglav Z, Mulholland K, Campbell H. Epidemiology and Etiology of Childhood Pneumonia. Bull World

Health Organ. 2008;86:408–16



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National Consultation on Childhood ARI Case Management: Translating Research to Policy and Program

determine the best approach for ARI case

management, it is necessary to accept the

available global evidence and contextualize

it within the prevailing diversity of India.

He also stressed that the countdown for the

Millennium Development Goals (MDGs) hasalready begun, and there is an urgent need to

move rapidly to achieve them. He highlighted

that every fifth child dies of pneumonia,

which calls for refinement of the existing

policies and an increased program thrust.

Dr. Vijay Kumar from WHO-SEARO served as

Chair of the session. He began by highlighting

the importance of ‘communitization’ of

programs. He emphasized the pertinence

of the third “P” for “People” while striving to

translate policy to programs. He also pointed

that most of the deaths occur among poor

children in urban slum and rural areas and

continue to be a serious impediment to

the achievement of MDG 4 – reduced child

mortality. He shared a few interventions on

standard case management implemented

for more than 20 years on the basis of which

Haemophilus influenza B and pneumococci

conjugate vaccines were added. He also

stressed that much of childhood pneumonia

and ARIs are preventable through exclusive

breastfeeding and complementary feeding,

micronutrient supplementation (vitamin A

and zinc) and reducing indoor air pollution.

Pneumonia Case ManagementGuidelines: Evidence fromMulti-centric Studies

Dr. Ashok Patwari, Research Professor in

International Health at the School of Public

Health in Boston University (BU) and Senior

Technical Advisor with MCH-STAR Initiative,

briefed about the engagement of the Centre

for International Health and Development

(CIHD), Boston University, in conducting

the policy research pertaining to pneumonia

case management. He gave an overview

of the multi-center clinical trials done at

CIHD to improve ARI case management and

reduce childhood mortality associated with

pneumonia. Dr. Patwari summarized the

evolution of the ARI control program, launched

in late 80s to respond to alarming under-five

mortality on account of pneumonia, the case

classification and choice of anti-microbial

agents based on available evidence followed by

incorporations in guidelines of Child Survival

and Safe Motherhood (CSSM) program, and

later in Reproductive and Child Health (RCH)

and Integrated Management of Neonatal and

Childhood Illnesses (IMNCI). He then raised

some of the common issues pertaining to

Pneumonia Case Management guidelines

which Boston University has addressed by

conducting multi-centric studies in some of

the developing countries.

Dr. Patwari referred to the Boston University

study published in Lancet (Lancet 2004, 363:



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1141-48) to address the question of “Can

we replace injections by oral medications

for severe pneumonia?” This randomized

multi-center equivalency study, conducted

by Amoxicillin Penicillin Pneumonia

International Study (APPIS) group, included asample size of 1702 children from nine study

sites (8 countries, 3 continents) to look into

oral amoxicillin versus injectable penicillin

for severe pneumonia in children aged

3-59 months. The results showed an equal

treatment failure of 19% and 22% in both the

groups at 48 hours and 5 days respectively.

Thus, the study concluded that injectable

penicillin and oral amoxicillin are equivalent

for severe pneumonia treatment in controlled

settings and there are certain potential

benefits of oral treatment when compared to

injectables, like reduced risk of needle-borne

diseases, need for hospitalization and referral

costs.

With regard to ambulatory treatment for

severe pneumonia, he mentioned that

hospitalization and referrals are issues

of concern in India and in many of the

developing countries. Apart from the

difficulties faced in hospitalization and

referral, risk of pneumococcal infection and

even the inadequacy of the health system

in providing needles and syringes are issues

of concern. The study, “New Outpatient

Short-Course Home Oral Therapy for Severe

Pneumonia (NO-SHOTS)”3, published in

Lancet in 2008, looked at 2037 children, aged

3-59 months, with severe pneumonia at seven

study sites in Pakistan. The study concluded

that home treatment with high dose oral

amoxicillin is equivalent to parenteral

ampicillin for severe pneumonia without

underlying complications.

The third issue he posed to the audience was,

“Whether to continue with chloramphenicol

as the first line treatment for very severe

pneumonia?” The Severe Pneumonia

Evaluation Antimicrobial Research (SPEAR)

study, a collaboration between BostonUniversity, WHO and Johns Hopkins

University, was an open label randomized

controlled trial with 958 children from tertiary

care hospitals in seven countries.4 The study

results showed more treatment failures with

chloramphenicol on day 5 as well as by days

10 and 21 and isolation of S. pneumoniae

associated with increased risk of treatment

failure in the chloro-group on day 21,

thus, concluding that injectable ampicillin

plus gentamicin is superior to injectable

chloramphenicol for community-acquired

pneumonia.

Summarising the findings from the studies,

Dr. Patwari concluded that there is a need

for targeted research to improve ARI case

management guidelines and simultaneously

update current WHO guidelines for

management of severe pneumonia. The

growing resistance pattern of S. pneumoniae

and the risk of treatment failures need

to be seriously considered and evidence

needs to be built to support switching

over from parenteral to oral therapy in

severe pneumonia. In addition, the risk of

hypoxaemia and need for oxygen therapy also

need to be considered.

Preventing Severe BacterialPneumonia in South Asian Region

Dr. Kurien Thomas, Christian Medical

College, Vellore began his presentation by

highlighting the global and national burden

3 Hazir T, Fox LM, Nisar YB, Fox MP, Ashraf YP, MacLeod WB, et al. Ambulatory short-course high-dose oral amoxicillin for treatment

of severe pneumonia in children: a randomised equivalency trial. Lancet 2008; 371:49-56.4 Asghar R, Banajeh S, Egas J, Hibberd P, Iqbal H, et al. Chloramphenicol versus ampicillin plus gentamicin for community acquired

very severe pneumonia among children aged 2-59 months in low resource settings: multicentre randomised controlled trial (SPEAR

study). BMJ 2008; 336: 80 - 84.



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of childhood pneumonia. He also presented

the geographic variation and concentration

of pneumonia, wherein it is estimated that

85% of childhood pneumonia deaths occur

in Sub-Saharan Africa and South Asia where

47% of children reside. Improved nutrition,

reduction of risk factors (such as indoor

air pollution, crowding, etc.), appropriate

vaccination and improved case management

and treatment constitute the child survival

package to prevent pneumonia in children.

After breastfeeding, which is estimated to

prevent 13% of all child deaths, vaccination

is considered one of the top preventive

interventions for children less than five

years of age, with the pneumococcal vaccine

estimated at saving 6-9% of all child deaths.

He also mentioned the South Asian

Pneumococcal Alliance (SAPNA) and

Invasive Bacterial Infections Surveillance

(IBIS) studies, in which the sample included

children in the age group of 2 months to 5

years, with high fever ( >38°C) of less than five

days duration and having clinical syndrome

of pneumonia, meningitis or severe illness

(i.e. sepsis). The clinical outcome of children

less than 12 years showed that 95% had

normalized, 3% had worsened, and 2% died.

He observed that though the case fatality was

not very high at the tertiary level, the absolute

number of cases was very high, reflecting the

extent of child mortality.

Based on surveillance data collected from

1993 to 2008, Dr. Kurien Thomas shared the

level of anti-microbial resistance in 718

S. pneumoniae isolates, with cotrimoxazole,

the first choice of drug for respiratory diseases

till recently, showing increasing resistanceover the years and reaching 82% resistance

in 2008. Though the data is from tertiary

settings, it may be a useful consideration in

recommending an alternate to cotrimoxazole.

In India, fortunately the penicillin resistance

continues to be low at approximately 12%,

but a few high level resistant organisms have

begun to emerge over the last two years.

Additionally, neighboring countries are

experiencing high levels of resistance, which

is bound to penetrate into India, calling

for continued surveillance and a focus on

preventive strategies. Dr. Kurien then showed

the case of the drug chloramphenicol, to

which resistance dipped around the year

1996, corresponding to the emergence of

the multi-drug resistant S.typhi infections.

Practitioners stopped prescribing

chloramphenicol due to poor response,

leading to a fall in resistance over the years

including for S.pneumoniae . The case of

irrational prescription of antibiotics by

practitioners and its effect on drug resistance

was highlighted.

Through the sero-type distribution data

and the levels of anti-microbial resistance

seen in other countries (particularly in Sri

Lanka), Dr. Thomas recommended that

pneumococcal vaccine should be viewed

as an important strategy to save children’s

lives. He also quoted the WHO position

statement – “Recognizing the heavy burden

of pneumococcal disease in children and the

safety and efficacy of PCV7 in this age group,

WHO considers the inclusion of this vaccine

in national immunization programmes as a

priority.5”

5 World Health Organization. Pneumococcal conjugate vaccine for childhood immunization (WHO position paper). Weekly Epid.

Record 2006; 82: 93-104.



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In conclusion, Dr. Thomas cited the example

of Sri Lanka, where policy level changes have

been achieved by introducing pneumococcal

conjugate vaccine in national program with

much higher levels of penicillin resistance

and different serotype distribution. Raising the context of India, he mentioned that

Hib vaccine has been introduced in India,

primarily as a vaccine against meningitis in

children as part of Universal Immunization

Program (UIP) in eight states from 2009.

While the National Technical Group on

Immunization has recommended the

introduction of an appropriate conjugate

vaccine (PCV-10 or PCV-13), there is a need

to evaluate the operational issues associated

with the introduction of the vaccine.

Advances on the Treatment of Non-Severe Pneumonia (NSP)

In her presentation, Dr. Shally Awasthi,

King George’s Medical University, Lucknow

chronologically shared results from three

studies. The first study, “ISCAP Study-Double

Blind, Placebo Controlled Trial of 3 Versus 5

days’ Amoxicillin for Non-Severe Pneumonia

(NSP),” 6 compared the proportion of children

(2-59 months) presenting with non-severe

pneumonia, who achieve clinical cure

on day 5 with 3 days versus 5 days of oral

amoxicillin therapy. The study also compared

the proportion of enrolled children who

were judged to be clinically cured on day 5 of

enrolment, but relapse within the next 7 days

of observation with 3 days versus 5 days oral

amoxicillin therapy and also the proportions

who had resistant strains of S. pneumoniae or

H. influenzae in NSP cultures on day 0 and 14.

The study was conducted in the context

of cotrimoxazole being recommended as

the first line drug for NSP under India’s ARI

Control Programme, significant in vivo and

in-vitro resistance to cotrimoxazole being

reported, and clinical studies showing

high treatment failure with cotrimoxazole.

Therefore, there was a need to switch to the

next recommended drug, amoxycillin. Since

the cost of treatment with amoxycillin is high,

the other option was to investigate whether

a shorter course of treatment would be as

effective as conventional treatment, as seen

in cases of urinary tract infections. Inferring

from the study, Dr. Awasthi concluded that

oral amoxicillin for three days is as effective

clinically as five days in the treatment of

children 2-59 months old suffering from

NSP and in the nasopharyngeal isolates of

S. pneumonia on days 12-14, an increase in

in-vitro resistance to cotrimoxazole was seen

with 5-day treatment.

Dr. Awasthi next discussed a second study

published in an online scientific journal

PLoSONE titled, “Does Three-Day Course

of Oral Amoxycillin Benefit Children of

Non-Severe Pneumonia with Wheeze: A

Multi-centric Randomised Control Trial?”

It was based on the rationale that the

current IMCI algorithm prescribes that

children with wheeze and fast breathing

that present to first level health facilities

should be given antibiotics if they continue

to have fast breathing, which is above the

age dependent respiratory rate cut-off of

WHO defined pneumonia, after two doses of

bronchodilator. While the primary purpose

of the algorithm is to prevent mortality

due to bacterial pneumonia, an unknown

6 ISCAP Study Group. Three day versus five day treatment with amoxicillin for non-severe pneumonia in young children: a

multi-centre randomized controlled trial. BMJ 2004; 328:791.



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proportion of children managed in this

fashion could have a viral-related wheezing

illness or asthma rather than pneumonia.

Further, about 20% children with WHO

criterion of non-severe pneumonia have

wheeze on auscultation, with nearly half of them having a history suggestive of asthma

and the remaining half have bronchospasm

as a presentation of bronchial asthma,

bronchiolitis or bronchopneumonia. In all of

these conditions, with the possible exception

of bronchopneumonia, there is no role of

antibiotics.

The study concluded that treating children

with non-severe pneumonia with wheeze

with a placebo is not equivalent to treatment

with oral amoxicillin. The study also found

that among cases of non-severe pneumonia

and wheeze, the respiratory rate came back

below age specific cut-offs in 46% children

after nebulization with salbutamol and thus,

there was no need to prescribe antibiotic.

The IMCI guideline also recommends the use

of bronchodilators among wheezers before

deciding to treat them as cases of pneumonia

with antibiotics. The final conclusion was

that the implementation of IMCI guidelines

in ambulatory care settings in India as well

as other developing countries will result in

a substantial reduction in prescription of

antibiotics for non-severe pneumonia.

The third study was on “Effectiveness of 3-

Day Amoxicillin Versus 5-Day Cotrimoxazole

in the Treatment of Non-Severe Pneumonia

in Children Aged 2-59 Months of Age: A

Multi-centric Open Labeled Trial.”7 This

study was based on the rationale that the

emergence of resistance in S. pneumoniae

or H. influenzae to cotrimoxazole warrants

a change in the case management of non-

severe pneumonia. An alternative could be

amoxicillin. However, use of amoxicillin at the

peripheral level would incur huge expenses to

the government. An alternative to this could

be a shorter course of amoxicillin with the

dual advantage of being less expensive and

arresting the emergence of drug resistance.

The inferences from this open labeled trial3 showed no difference in treatment of NSP

with either cotrimoxazole or Amoxicillin

but were not tested for equivalence. The

recommendations from this study were that:

There is no need to change the existing

national guidelines of treating non-severe

pneumonia with cotrimoxazole twice in a

day for five days.

It is essential to nebulise NSP (~13%

cases) with wheeze prior to giving

amoxicillin, since this averts antibiotic

use in almost 40% cases. Further,

appropriate bronchodilator therapy is

needed in those with NSP with wheeze.

It is recommended that in all healthcare

set-ups, provision to nebulise children

presenting with wheezing should be

provided as this is a simple, cost-effective

strategy.

Lastly, continuous monitoring is

required as anti-microbial resistance

pattern changes, and further changes

are anticipated with the introduction of

Hemophilus vaccine.

Care-seeking Behavior of Mothers:Findings from the IMNCI Baseline

Assessment of Childhood Morbidity and Mortality in Selected Districts inIndia

Dr. Arora echoed Dr. Vijay Kumar’s

views about the importance of people’s

participation. His presentation focused on

the IndiaCLEN Program Evaluation Network

(IPEN) study conducted in 2007-08, the

objective of which was to assess the extent to

which IMNCI improves the management of

childhood illnesses, health system logistics,

7 Awasthi S, Girdhar A, Singh JV, Kabra SK, Pillai RM, et al. Effectiveness of 3-Day Amoxicillin vs. 5-Day Cotrimoxazole in the

Treatment of Non-severe Pneumonia in Children Aged 2–59 Months of Age: A Multi-centric Open Labeled Trial. Journal of Tropical

Pediatrics 2008; 54(6):382-389.



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and community involvement for child

survival activities in India. The study helps

provide baseline estimates of mortality: Infant

Mortality Rate (IMR), Neonatal Mortality

Rate (NMR), Under-five Mortality Rate

(U5MR); baseline estimates of morbidity:

cough, fever & diarrhea, existing health and

care seeking practices of community for

children under five; and existing practices of

care providers for management of illnesses

less than five years. Two districts each from

four Empowered Action Group (EAG) states,

namely Uttar Pradesh, Rajasthan, Orissa, and

Madhya Pradesh and from non-EAG states,

namely Meghalaya, Karnataka, Maharashtra

and Haryana, were included in the study.

A period prevalence range of 20-40% with

some symptoms of illness (cough, fever and

diarrhea) was found. Out of those children

who had illness, 50 to 60% had fever. There

was a district to district variation for children

who sought care outside home for any illness,

varying between 17% in Mewat district of

Haryana which is the poorest performing

district in the country and 45 to 47% in Orissa,

Maharashtra and UP. Healthcare seeking

outside the home for cough was 35-40%,

except in Meghalaya which goes up to 55%.

Care seeking outside the home was 80-90%

when the mother perceived it to be a serious

illness. Agreement between perceived severity

of the illness by the mother and objective

severity (indicators – fast breathing, decrease

in breathing and decrease in drinking) was

75-80%. Between 50-80% of the times,

mothers were not able to perceive less feeding

and less drinking as symptoms of severity,

when child had definite severe illness.

In the context of home treatment, whether

it was a mild or severe illness, across all the

states, 35-40% mothers gave some kind of

home treatment, which could have delayed

taking the child to the facility. The confidence

in the quality of care and prescriber

characteristics determined the decision to

seek outside care in 65-70% cases, urgency to

seek care in 30-40% cases, and accessibility

and affordability in around 20% cases.

Verbal autopsies revealed that of the

714 neonatal deaths, 45% never visited any

health facility before dying. Of those who did

not visit any health facility, two-thirds received

home treatment. On the other hand, only

one-third of the newborns who visited the

health facility received any home treatment.

In the case of post-neonatal deaths, 40% never

visited any health facility, 60% visited a health

facility. Again, two-thirds of those who never

visited the health facility got home therapy

and 40% those who visited got home therapy.

Expectedly, in the case of children less than five

years who had recovered, recovery was higher

(78%) for those who visited a health facility

compared to those who never visited (22%).

Home-based treatment in all children was

approximately 40%.

In conclusion, approximately 40-45% of those

who died were never taken to a health facility,

and two-thirds of these children received

some form of home therapy (compared

to one-third of those who were taken to

health facility). Perceived severity of illness

by the mother was a predictor for seeking

care outside the home. Most mothers did

not perceive “less drinking and less eating”

in the presence of other symptoms, as an

indicator of severity. Prescriber characteristics

and quality of care were the dominant



10


determinants in choosing a particular

health facility/care provider versus issues

related to access and affordability. Transport,

finance and social support emerged as major

difficulties for care providers when they

decided to take their children to a healthfacility.

Panel Discussion: Translating Research Finding to Policy andProgram

Dr. Sangeeta Saxena, Assistant Commissioner

(Child Health), MoHFW, Government of

India, emphasized that with the MDGs in

place and international advocates striving to

put maternal and child health at the center

stage, the role of such workshops is pivotal

to draw attention to evidence for advocacy of

cost-effective interventions. Along with the

information available from the monitoring

system and the evaluation studies, research

evidence on what can work at scale in

our country will be useful in accelerating

progress towards maternal and child health.

She welcomed the consultation as a timely

discussion, and requested closer involvement

with the Government of India to take the

recommendations forward.

Dr. Vinod Paul, Head of the Pediatrics

Department and IndiaCLEN ClinicalEpidemiology Unit, AIIMS, moderated

the panel discussion on assessing the

policy implications of the research studies.

The expert discussants and the audience

responded to the issues emerging out of

research evidence shared in the previous

session.

The main issues that came out of the panel

discussion and recommendations from the

panelists and the audience are summarized

below:

1. Possible evidence that need to be

incorporated into the program

a. Pneumonia can be recognized at

the community and facility level. Its

treatment exists and is affordable. There

is overwhelming evidence that standard

case management works. However,



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delay in getting treatment is a major

constraint.

b. Measles and pertussis immunization

coverage rates need to be increased to

levels that eliminate it as a public health

threat. This is an unfinished agendarequiring greater rigor, and NRHM

provides an opportunity to strengthen

the health system to deliver the routine

immunization programme.

c. Additional vaccines such as Hib and

pneumococcal vaccine need to be

reviewed with caution, and perhaps more

evidence needs to be garnered before a

policy decision can be made.

d. We need to further explore the

relationship between ARIs and protein

energy malnutrition, micronutrient

deficiencies, exposure to smoke and

overcrowding, and equity and access to

health services.

2. Recommendations related to ARI case

management

a. Non-severe pneumonia

While there is evidence from tertiary care

settings, there is little information on

the etiology and micro-organisms from

community settings. More information will

need to be generated on the etiological agent

and anti-microbial susceptibility, and changes

over time. Existing evidence does not greatly

support a change from cotrimoxazole to

amoxicillin or any other antibiotic. Therefore,

status-quo should be maintained, while

continuing to be vigilant and keeping the

program and policy informed of the latest

research developments. Research gaps need

to be addressed by generating community-

based data.

b. Severe pneumonia

There are two issues for discussion – whether

a short course can be given at the hospital,

and if these cases can be treated at home.

Short course seems an attractive proposition,

once the data is firm and defendable. Oral

therapy can be given for pneumonia, but not

severe pneumonia. Till there is more India

specific data, treatment with injectables

needs to be continued for severe pneumonia.

Results from the IndiaCLEN’s multi-centric

Severe Pneumonia Oral Therapy (ISPOT)

study on use of oral amoxicillin, currently underway, may be useful, once available. Lady

Hardinge Medical College’s to-be-published

research on treatment with antibiotics in a

scenario of viral pneumonia will also provide

important evidence in the treatment of

severe pneumonia. For severe pneumonia,

the decision for the treatment drug should

be based on whether referral to a hospital is

possible or not. If referral is not possible, oral

amoxicillin (high dose 80-90 mg/kg/day) for

five days should be prescribed. If referral is

feasible, injectable penicillin or ampicillin

should continue as drug of choice for severe

pneumonia. This is so because of paucity of

evidence for home-based treatment of severe

pneumonia. Where referral is not possible, the

capacity of the health worker needs to be built

to recognize severe pneumonia and manage

the case. However, a caveat is that ANMs are

not allowed to administer amoxicillin and

thus, this would require a policy change.

c. Wheezing

Dr. Awasthi’s study provides good evidence

towards nebulization of children with

lower ARI. The feasibility of using spacing

devices is not an issue; rather, the issue is

of capacity and acceptance of program,

and empowerment of health worker. We

need to revise the protocol for wheezing

management in the IMNCI algorithm with

the need to incorporate wheezing box as

an essential equipment for facility settings.

At the Primary Health Centre (PHC) level,

metered-dose inhalers with spacers should be

made available. Urgent feasibility studies are

required in community settings.

3. Role of ASHA in ARI case management

The issue of Accredited Social Health

Activist (ASHA) being allowed to administer



12


cotrimoxazole, as being done by Auxiliary

Nurse Midwifes (ANMs) and Anganwadi

Worker (AWWs), was discussed. In

Chhattisgarh, ‘Mitanins’ (ASHA equivalents)

have been equipped with training and

supplies to administer cotrimoxazole, butthere has not been any assessment so far.

Participants cautioned that while the issue of

equity is critical, the issue of accountability

and capacity of other health workers also

needs to be kept in mind rather than putting

responsibility on ASHA. Everyone agreed

that ASHAs could possibly manage ARI

cases in the communities. While the idea of

empowering ASHA to manage ARIs seems

like a practical solution, it is important to test

the effectiveness through a pilot study before

taking to scale.

4. Role of IAP in improving treatment of

pneumonia

Dr. Panna Choudhury, President, IAP,

described IAP as the only official body of

ediatricians with 17,000 members and

300 branches across the country. IAP frames

guidelines for its members, which are also

widely utilized by other professional bodies

and the government. For instance, the zinc in

diarrhea policy was first framed by IAP. These

guidelines are updated time and again. Three

clear opportunities for partnership with IAP on

the issue of ARI case management emerged:

a. Under the aegis of its respiratory chapter,

IAP can set up a task force to review the

literature and the evidence and bring out

guidelines for ARI case management,

particularly at the facilities.

b. IAP can also be involved in the training of

providers on ARI management protocol

due to its large presence throughout the

country.

c. Guidelines are required for when not

to use antibiotics. IAP can write a white

paper on rational use of antibiotics and

publish it within four months in the

Indian Pediatrics (official journal of the

Indian Academy of Pediatrics).

5. Operations research areas and the

pathways to plug gaps in the evidence

The following areas of operations research

were identified as priorities:

a. There is sparse information fromcommunity settings, both in terms of

etiology and organisms, and therefore,

more information on etiological agents

and anti-microbial susceptibility, and the

change over time and community based

data is essential.

b. Urgent feasibility studies are required in

community settings for incorporating

metered dose inhalers at PHC level

facilities.

c. Review and further analyze NFHS-3 and

IMNCI baseline data on health seeking

behavior for ARI management.

d. Look at antibiotic use in well-nourished

children from Dr. Awasthi’s study and

BU studies.

e. Review data on children with chest

indrawing since they are seldom taken to

hospital.

i. Further in-country research on oral

therapy for severe pneumonia. Is

ambulatory treatment possible for severe

pneumonia?

f. Conduct research on increasing the

utilization of facilities by communities,

and operational issues of how to improve

the outcomes of children brought to the

system by strengthening the facility and

increasing the credibility of the provider

in the community.

g. Bringing improvement in the home-

based care by the parents whose child is

suffering from pneumonia.

h. The use of antibiotics for children who

reported fever, cough and rapid breathing

is about close to 20% in the country

as a whole. Therefore, there is a gross

under-utilization of antibiotics when it

is required. How to optimize the use of

antibiotics for severe ARI is an important

research question.



13

Proceedings

Dr. Reeta Rasaily from the Indian Council

of Medical Research (ICMR) pointed that

the basic mandate of ICMR is to promote

research in the country and provide useful

evidence for incorporation into the program.

Pneumonia, with its high morbidity andmortality burden, is a priority for ICMR. She

indicated that the research priorities were

well-listed and ICMR would be happy to

support research activity in this regard. ICMR

is in the process of having expert group

meetings to finalize priorities to take up for

achieving MDG 4, and the recommendations

very much fit into ICMR priorities. Sheconcluded that ICMR welcomed research

proposals in this regard.



14

Dr. N.K. Arora pointed out that there is a need

to engage with the Ministry more closely to

take the recommendations forward. A brief

document with rationale and justification can

be prepared as a background document and

shared with the MoHFW. The development

partners, researchers and academicians

present in the meeting should contribute

to that document. Two additional exciting

opportunities are available for taking the

recommendations to policy and program. The

adaptation group of IMNCI and draft child

III.Next Steps on Taking the

Recommendations Forward

health policy are in the process of finalization;

the deliberations from this consultation could

be incorporated in both.

The consultation concluded with a synthesis

of the discussions by Dr. Vinod Paul, a vote

of thanks by Dr. Marta Levitt-Dayal, Chief

of Party, MCH-STAR, and presentation of

partnership plaques to representatives from

IAP, ICMR, and Government of Uttar Pradesh

on behalf of IndiaCLEN, MCH-STAR and

USAID.



15

National Consultation onChildhood ARI Case Management: Translating Research to Policy

and Programme

Gulmohar, India Habitat Centre, Lodhi Road, New Delhi

February 25, 2009 from 10:00 am to 2:00 pm

Program

9:45 am – 10:00 am Registration with tea

10:00 am – 10:10 am Welcome, Dr. Kurien Thomas, IndiaCLEN

10:10 am – 11:45 am Presentations : Evidence from Global and National Research on

Childhood ARI

Chair:

Dr.Vijay Kumar, WHO/SEARO

Moderator:

Dr. Rajiv Tandon, USAID

Presenters:

Dr. Ashok Patwari, Boston University

Dr. Kurien Thomas, IndiaCLEN

Dr. Shally Awasthi, IndiaCLEN

Dr. N.K. Arora, IndiaCLEN

11:45 am – 1:30 pm Panel Discussion: Translating Research Findings to Policy and

Programme

Moderator:

Dr Vinod Paul, AIIMS

Panelists:

Dr. Sangeeta Saxena, MoHFW, Government of India

Dr. Panna Choudhury, IAP

Dr. Reeta Rasaily, ICMR

Dr. Vijay Kumar, WHO/SEARO

Dr. N.K. Arora, IndiaCLEN

1:30 pm Vote of thanks, Dr. Marta Levitt-Dayal, MCH-STAR1:40 pm onwards LUNCH

Annex 1

IV. Agenda



16

National Consultation onChildhood ARI Case Management: Translating Research to Policy and Program

February 25, 2009, New Delhi

List of Participants

S. No. Name Organization E-mail

1 Dr. Rajiv Tandon USAID [email protected]

2 Dr. Kurien Thomas IndiaCLEN, Vellore [email protected]

3 Dr. Shally Awasthi IndiaCLEN, Lucknow [email protected]

4 Dr. Vinod Paul IndiaCLEN, AIIMS [email protected]

5 Dr. Reeta Rasaily ICMR [email protected]

6 Dr. Vijay Kumar WHO-SEARO [email protected]

7 Dr. N. K. Arora INCLEN [email protected]

8 Dr. Rajmohan Pillai IndiaCLEN,Trivandrum [email protected]

9 Dr. Shamim Haider IndiaCLEN [email protected]

10 Dr. Pancholi IndiaCLEN [email protected]

11 Dr. Rajiv Sharan IndiaCLEN [email protected],

12 Dr. Najam IndiaCLEN [email protected]

13 Dr. Sudhansh Malhotra WHO-SEARO [email protected]

14 Dr. V. K. Anand WHO, India [email protected]

15 Dr. Pavitra Mohan UNICEF [email protected]

16 Dr. Manoj Kar NHSRC [email protected]

17 Dr. G. R. Sethi MAMC

18 Dr. Panna Choudhary MAMC and IAP [email protected]

19 Dr. R.N. Mandal MAMC

20 Dr. Satinder Aneja LHMC [email protected]

21 Dr. Arvind Saili LHMC [email protected]

22 Dr. Sushama Nangia LHMC [email protected]

23 Dr. Umesh Kapil AIIMS [email protected]

24 Dr. Shinjini Bhatnagar AIIMS

25 Dr. Sriram Krishnamurthy INCLEN [email protected]

26 Vaishali Deshmukh INCLEN [email protected]

27 Jyoti Dhavan INCLEN [email protected]

28 Dr. A. K. Patwari MCH-STAR [email protected]

29 Anju Dadhwal Singh MCH-STAR [email protected]

Annex 2

V. Participants



17

30 Dr. Indrajit Hazarika MCH-STAR [email protected]

31 Dr. Sangeeta Saxena MoHFW, Govt. of India [email protected]

32 Rashmi Kukreja DFID [email protected]

33 Dr. Hanimi Reddy Vistaar Project [email protected]

34 Dr. Sunil Kumar

35 Dr. Luke Ravi MMC Chennai [email protected]

36 Rachna Sujay Hope Foundation [email protected]

37 Dr. Rais Ahmed MoHFW, Govt. of UP [email protected]

38 Dr. Anand Lakshman Micronutrient

Initiative

[email protected]

39 Dr. Melina Thakur INCLEN [email protected]

40 Dr. Marta Levitt-Dayal MCH-STAR [email protected]

41 Tapati Dutta MCH-STAR [email protected]

42 Dr. Avinash Ansingkar MCH-STAR [email protected]

43 Dr. Sanjeev Upadhyaya USAID [email protected]

44 Manoj Kohli CEDPA [email protected]

Participants







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