Increasing coverage and improving quality of facility-based management of newborn infection

Fatima Mir Assistant Professor Pediatrics and Child Health Aga Khan University

Contents
Facility based newborn care
History Existing standards Possible Impact on newborn mortality

Newborn infection
Case definitions and standard of care in different settings

Maternal infection
Case definitions and standard of care in different settings

Field notes from Pakistan

First Level Second and Tertiary Level

Shadoul et al. EMHJ Vol 16 Supplement 2010

District Health care System in Pakistan

Tiers
Health Houses : 99097 Basic Health Unit: 12449

Capacity
100,000 plus 1/10,000-25,000
MO/LHV/Vaccinator/Health technician/Dispenser/sanitary worker

Rural Health Center: 596

1/50,000-100,000
MO/LHV/midwife/vaccinator/lab/dis penser/ radiology/OT/anesthesia 15-20 bed

Maternal and Child Centers Tehsil Headquarter Hospital District Headquarter Hospital: 989 Tertiary Teaching Hospitals:

LHV, TBA 0.5-1 million; 40-60 bed 1-3 million; 125-250 bed

Sabih et al. EMHJ. Vol 16, Supplement 2010

Pakistan Maternal and Child Health Policy and Strategic Framework 2005-2015

Gaps in quality & coverage

First level
Antenatal care
Access
UTI, fever in pregnancy, TT coverage Parenteral/oral appropriate antibiotics Laboratory support

Perinatal

Postnatal

GBS prophylaxis, clean delivery kit, incentivizing facility based deliveries, vital statistic registry, sensitizing to PROM Identification and diagnosis of serious bacterial infections in both mothers and newborns Case based management of common infections in newborns and mothers Facilitated and safe referral Plan B for refusals
IMNCI

Facility based care for infection: measuring impact

IMCI
Gouws et al 2004 Arifeen et al 2005
Appropriate dose, communication with caregiver, first dose at center Baseline survey pre-IMCI; danger signs, growth, correct classification, correct treatment, correct counselling

F-IMNCI

Bhandari et al 2012 Neogi et al

FBC-newborns

Neonatal mortality in home births, neonatal care packages

Regionalization, quality of care at Level 1&2; training and investment in level 3

Newborn infections
10% of all child deaths
Sub-Saharan Africa & South East1

Spectrum
Neonatal sepsis Pneumonia/meningitis/omphalitis/ophthalmia neonatorum/HIV/tetanus

Signs and Symptoms

Subtle Overt
Black et al. Lancet 375:1969-1987, 2010 Ganatra and Zaidi. 2010. Semin Perinatol 34:416-425

Diagnosis and Management of Newborn Infections

Facility
Case definitions follow standard medical textbooks Assessors more skilled and trained Assessor can distinguish to a greater extent btw infection, prematurity and asphyxia with laboratory and radiology support Gold standard management possible at secondary and tertiary care facility Quality of care at secondary and tertiary care facility poorly supervised and non-harmonized

Community
Case definitions follow clinical algorithm validation studies in various regions Assessor may miss subtle signs Assessor does not have laboratory support due to which overlap/ambiguity may remain Standard of care may be an under-studied Poor systems for facilitated referral of high risk newborns

Case definitions in community settings

Ganatra and Zaidi. 2010. Semin Perinatol 34:416-425 Young Infants Clinical Signs Study Group: Lancet 371:135-142, 2008

Diagnosis and Management of Maternal Infections

Facility
Case definitions follow standard medical textbooks and WHO recommendations Assessors skilled and trained Assessor is aware of referral tier Assessor can distinguish to a greater extent btw infection, prematurity and asphyxia with laboratory and radiology support. Gold standard management possible at secondary and tertiary care facility Quality of care at secondary and tertiary care facility poorly supervised and nonharmonized

Community
Case definitions not clear Assessors and recently delivered women not aware of puerperal sepsis as a individual entity Assessor does not have a facilitated referral system in place Not trained to utilize laboratory and radiology resources Gold standard management at community level not defined Quality of care and referral tier at LHW

Facility based Newborn care operational guide. India. 2009 Bhutta. Semin Neonatol 1999; 4:159-171 Meem et al. JOGH Vol. 1 No. 2 Dec 2011

Field Notes from Pakistan

Neonatal Sepsis

The SATT trial

Maternal Sepsis
M-ANISA
CHW and PHC physician training PHC-tertiary care liaison Facilitated referral

ANISA study

PHC-tertiary care liasion Facilitated referral Other causes behind treatment failures (I-POP) Efficacy data in addition to clinical effectiveness data (POP-PK)

Voucher schemes

Greenstar voucher scheme

Jhang District (Punjab) Charsadda (KP)

Courtesy: Dr Momin Kazi, Demogrophic Surveillance System , AKU

Population Under Surveillance

Site Total Pop Male Female Females 15-49 years Number of Children Under 5 4645(15%) 11023 (14%) 8,939 (14%) 8,360 (15%) 6,061 (13%) 39,028(14%)

Rehri Goth Bilal Colony Ibrahim Hyderi Ali Akber Shah Bhains Colony Total

31,969 76,361 65,891 54,834 45,801 274,856

16,778(52%) 41,129 (54%) 33,984(52%) 28,218(51%) 24, 770 (54%) 144,879 (53%)

15,191(48%) 35,232 (46%) 31,907 (48%) 26,616 (49%) 21,031 (46%) 129,977 (47%)

7721(24%) 17,351 (22%) 18,253 (28%) 12,710 (23%) 11,767 (26%) 67,802 (25%)

Courtesy: Dr Momin Kazi, Demogrophic Surveillance System , AKU

Important Rates
Site Rehri Goth Bilal Colony Ibrahim Hyderi Ali Akber Shah Bhains Colony Total GFR 154.4 106.6 116.8 159.3 135.3 128.3 CBR 36.5 28.4 34.5 32.9 37.4 33.2 NMR 42.8 40.0 36.9 26.8 26.4 34.4 U5MR 78.0 50.3 57.4 41.0 38.9 51.9 MMR 59.4 29.5 24.1 39.2 29.6 33.9

GFR= General Fertility Rate (annual # of births per 1,000 women of reproductive age (14 49 years)) CBR= Crude Birth Rate (live births per 1,000 population) NMR= Neonatal Mortality Rate (death of children 0-27 days/1000 live births) U5MR= Under 5 Mortality Rate (death of < 5 years old / 1000 live births) MMR= Maternal Mortality Ratio (maternal deaths per 100,000 live births) Courtesy: Dr Momin Kazi, Demographic Surveillance Systems, AKU

DSS ID
Center Para Block Structure Household Mother Child

Center name Para name Block number Structure number Household number Mother number Child number
Courtesy: Dr Momin Kazi, Demographic Surveillance Systems, AKU

Bilal colony primary health center

Bhains colony primary health center

Simplified Antibiotic Regimens for the Management of Sepsis in Young Infants in First-level Facilities: Randomized Controlled Trial

This trial evaluates primary care clinic-based simplified antibiotic therapy options for young infants, 0-59 days old in high neonatal mortality settings in peri-urban Karachi where hospital referral is frequently refused by families

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The SATT Trial

Outcomes
Success Treatment Failure
9-11% fail first line therapy
30% of 11% fail second line 16 children underwent an echo and a CXR 4 had life threatening heart and lung disease

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ANISA Surveillance Karachi site Step 1: Married women Surveillance and under 5 listing Step 2: New pregnant women identified 2 ANC sessions Step 3: Pregnant women follow ups Step 4: Child birth and Registration in ANISA with in 0-6 days of birth Step 5: New born follow ups at day 2, 6, 13, 20, 27, 34, 40, 48, 59 Step 6: SEPSIS screening by health worker Step 7: Referral of all those who identified as SEPSIS based on 7 criteria Step 8: If referral accepted Physician assessment at PHC Step 9: Enrolled as SEPSIS if criteria meet 1 pair of CHW for Pick/drop 4-5 pairs of CHWS 1 Senior health staff + 1 CHW 4-5 pairs of CHWS 3-4 pairs of CHWS

Integration of pulse oximetry into the routine assessment of young infants at first-level health centers in Karachi, Pakistan
Hospital for Sick Children Toronto Aga Khan University

Aga Khan University (AKU) Young Infant Surveillance in Karachi

Pregnancy surveillance Antenatal visits Birth notification Post-natal visits (0-59 days) Community iPOP Clinic assessment Diagnosis of very severe disease Self-referral (by caregiver)

ANISA

SATT

Treatment and/or referral by physician

Clinic

High dose oral amoxicillin attains pharmacokinetic efficacy endpoints in young infants (0-59 days) with suspected sepsis
A population pharmacokinetic pilot study
Principal Investigator: Fatima Mir Supervisers: Drs Anita KM Zaidi and Shagufta Khan (AKU) Dr Susan Abdul-Rahman (CMH Kansas) Dr Harry Keyserling (Emory)

Funded by a Fogarty grant 1D43 TW007585-01 as part of MSCR Thesis at Emory

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Conclusion
Oral amoxicillin concentrations in 0-59 day old infants exceeded the susceptibility breakpoint for S. pneumoniae (2mg/L)

In 39 of 44 (88.6%) young infants at 2-3 hours of index dose In 19 of 20 (95%) young infants at 6-8 hours of index dose

Strong support in favour of oral amoxicillin with IM gentamicin as second line sepsis therapy
More information required on Funding from Save the Children for a larger study
renal clearance and trough levels at 12hours in this population

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Yasir et al. J Obstet Gynaecol Can 2009: 31 (10); 920-29

Supplement to ANISA: Development of a communitybased presumptive clinical diagnosis algorithm and treatment regimen for maternal puerperal sepsis
John Hopkins University Child Health Research Foundation Aga Khan University
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Project Goal: To prevent maternal deaths and long term health consequences of PP sepsis among women in three lowresource South Asian countries
Designed in 2 phases Phase 1
Designed in 2 phases Phase 2
In depth interviews with Recently delivered women Care providers in community and facility Female relatives of RDW Collate findings in a clinical algorithm to be administered by CHWs identify women with probable puerperal sepsis, other conditions and local infections eg. Mastitis or skin/wound validate a field-based clinical diagnostic tool measure incidence and determine risk factors for PP sepsis to inform preventive strategies and further refine the algorithm identify the aetiology and aetiology-specific incidence of community-acquired bacterial infections among ill postpartum women determine antimicrobial susceptibility patterns of bacterial isolates to inform development of appropriate simplified treatment regimens for PP sepsis for use at the community level.
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ANISA Surveillance Karachi site Step 1: Married women Surveillance and under 5 listing Step 2: New pregnant women identified 2 ANC sessions Step 3: Pregnant women follow ups Step 4: Child birth and Registration in ANISA with in 0-6 days of birth Step 5: New born follow ups at day 2, 6, 13, 20, 27, 34, 40, 48, 59 Step 6: SEPSIS screening by health worker Step 7: Referral of all those who identified as SEPSIS based on 7 criteria Step 8: If referral accepted Physician assessment at PHC Step 9: Enrolled as SEPSIS if criteria meet

MANISA Karachi site

Risk factors for PP sepsis
MWSR team/ Birth RA

RDW Follow up visits CHW follow up assessment CHW Suspected PP SEPSIS

NB team CHW

Referral to health center

Physician assessment Physician Suspected PP SEPSIS At Health Centre: Urine & Blood Specimen collection Endometrial specimen collection Hospital Management Discharge

Hospital Referral & Specimen collection

Algorithm ( Tool for PP Sepsis Diagnosis)

Section 7 : ALGORITHM WORKSHEET

SIGNS AND SYMPTOMS

CLASSIFICATION (ENCIRCLE IF INDICATED)

PP Sepsis
Suspected PP Sepsis
7.01

High fever (temperature 39.1C or higher) [Q6.01 = yes] (if present)

7.02

Fever (temperature 38.1C 39.0C) [Q6.02 = yes] Suspected PP Sepsis History of fever [Q2.01 = yes; Q 2.02 - response high or moderate], or [Q2.03 = yes] Abdominal or pelvic pain [Q2.04= yes]

7.03

7.04

7.05

Abnormal or foul-smelling discharge [Q2.09 = yes]

(Fever present at examination or history of fever AND any other sign or symptom listed is present)

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Algorithm- other conditions

Section 7 : ALGORITHM WORKSHEET Other Conditions 7.06

Severe Vaginal bleeding [Q4.02= yes] Severe headache AND blurred vision [Q4.04= yes AND Q4.05=yes] Leaking urine and/or stool [Q 4.06 =yes] Convulsions or unconscious [Q4.03 =yes] Abdominal pain (without fever) [Q2.04=yes AND 2.01= No] Fever (temperature 38.1C 39.0C) only -see list above to rule out sepsis symptoms/signs Q. 6.02 = Yes History of fever only [Q2.02 = response high or moderate], or [Q2.03 = yes] Suspected Local Infection Abnormal or foul-smelling vaginal discharge (without fever) [Q2.09=Yes AND 2.01= No] Burning on urination [Q3.07 = Yes] Cough or difficulty breathing [Q4.01=yes] Pus or pain from tear, C-section or episiotomy wound Q3.05 = Yes OR Q 3.06 = Yes Swollen, red, or painful breast [Q 3.01= if answer is any of 1 or 2 or 3 (any answer other than 0)] Other Suspected Illness (any listed symptom is present)

7.07

7.08 7.09

7.10

7.11

7.12

7.13 7.14 7.15 7.16

(any listed symptom is present)

7.17

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Physician Assessment- form 5

Section 6: CLINICAL ASSESSMENT OF THE MOTHER Temperature. May I please take your temperature? Please record the current temperature of the mother (by placing thermometer orally until it Beeps) if allowed. |___|___|___|.|___|F
put 999.9 if mother refused [Measure again after 10min if temperature is 100.6oF (38.1oC in 1st measurement and record bellow carefully and classify according to 2nd measurement] |___|___|___|.|___|F put 999.9 if mother refused 6.01 HIGH FEVER: temperature 102.4oF (39.1C) or higher 6.02 FEVER: Temperature 100.6oF 102.3oF (38.1C 39.0C) 1 Yes 2 No

1 Yes 2 No

Anemia (by observing lower sclera) 6.00 Pulse Count the pulse rate Abdominal Tenderness 6.05 Abdominal Tenderness

6.03 ANEMIA

1 Yes 2 No

6.04 Pulse rate

|___|___|_ __| 1 Yes 2 No

Blood Pressure

6.06 Blood Pressure (in mm of Hg)

Systolic:

Diastolic:

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CRF 2 & 5
Section 2: Determine if the woman has any PP sepsis symptoms and assess the severity of her symptoms 2.00 Yes 1

Between today and your delivery day [or between last 2 visits of CHW], did you have fever?

No

2.04

2.01

How many days had you suffered from fever?

|___|___| days If less than 1 day code 00

2.02

How severe do you think your fever was

Mild/low grade fever Moderate fever High grade fever Yes No Don't know Yes

1 2 3 1 2 8 1

2.03

Did your fever make you feel unable to stand or unable to get out of bed, or unable to complete chores? Between today and your delivery day [or between last 2 visits of CHW], did you have lower abdominal or pelvic pain?

2.04

No 2.05

2 1 2 3

2.08

Did the pain in your lower abdomen feel the same every day, or has it increased since the delivery/ over the period between last 2 visits of CHW?

Decreased Pain remained the same (until now) Increased

2.06

How severe do you think the pain is (or was)? Rate the severity from 0 to 10 looking at the following picture. Did the pain become more severe when touching or pressing the lower abdomen? Between today and your delivery day [or between the last 2 visits of CHW], did you have abnormal vaginal discharge present?
Yes No Don't know Yes 1 2 8 1

2.07

2.08

No

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Facility based management of infection

Case management
WHOs recommnedation of 3 IV antibiotics (Ampicillin, Metronidazole and gentamycin) until the woman is afebrile for 48 hours
Before providing treatment, specimen collection (urine, blood, endometrium)

Non-response to treatment
Correlate with culture results

Admission/ discharge
Obstetrician/gynaecologist history and exam
Endometrial tissue culture Antibiotic (parenteral) Discharge plan

Performance based incentives to increase coverage

Subsidizing Travel and Services in Pakistan
Greenstar voucher scheme (2008-09)
to encourage poor pregnant women to seek maternal health and FP services in Dera Ghazi Khan District in Punjab
More than 98 percent of women with vouchers delivered at health facilities
97% of whom had previously delivered at home7 More than three-quarters returned for FP counseling after delivery

Two similar voucher projects in Jhang and Charsadda districts with a greater focus on sustainability8
Sohail Agha. Reproductive Health 2011, 8:10

In summary
Census and demographic surveillance PHC
Newborns
IMNCI Facilitated and safe referral Liaision with tertiary care center/physicians Plan B for refusals Puerperal sepsis algorithm Facilitated and safe referral Liaision with tertiary care center/ physicians Liasion with local TBAs and maternity clinics Plan B for refusals

Secondary

Mothers

Tertiary

Customized newborn case management guidelines for Pakistan Customized maternal infection management guidelines for Pakistan Newborn Group within Pediatricians

Private-Public Partnerships
Advocacy

Optimize high level care