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Prevention and Care for BabiesBorn Too SoonGlobal Newborn Health ConferenceJohannesburg, South Africa
April 16, 2013
Cyril M. Engmann MD FAAP
Senior Program Officer, Neonatal HealthMaternal, Newborn and Child Health ProgramBill & Melinda Gates Foundation
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Outline
Preterm burden
Implementation & research horizons
Purpose-driven, catalytic partnerships
EVERY PERSON, INCLUDING NEWBORNSDESERVES THE CHANCE TO LIVE A HEALTHY,PRODUCTIVE LIFE.
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Note: rates by country are available on the accompanying wall chart. Not applicable=non WHO Members StateSource: Blencowe et al National, regional and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications
15 Million Preterm births a global problem
PRETERM BIRTH: BIRTH BEFORE 37 COMPLETED WEEKS OF GESTATION
10 countriesaccount for 60%
of the worlds
preterm births
1. India2. China3. Nigeria
4. Pakistan5. Indonesia6. United States
of America7. Bangladesh8. Philippines9. Dem Rep
Congo10. Brazil
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Preterm birth also a major issue in high-income countries
United States among top tencountries in terms of number of
preterm birthsPreterm birth costs developed
world ~$40B per year
IOM report from 2007 found that pretermbirth cost the US $26.2B per year1
Extrapolating to rest of developed worldbased on per-capita HC spend and PTbirth rate suggests cost of ~$40B annually
Creates unique opportunity to leverage investments & learning from low- andmiddle- and high-income countries to improve preterm birth and newborn health
1. Includes costs of medical care services, early intervention services, special education services, and lost household and labor market productivity. Methods: total economic cost associated with 1preterm baby estimated to be $51,600 in the US in 2005 (Behman et al). Estimate for other countries obtained by scaling each country's per capita health expenditure in 2005 to that of the US. Totaleconomic cost saved for a given country is cost per PTB infant x projected number of preterm births averted . Total sum here for all 42 UN high human development index countries (in green).Source: World Bank statistics, Behrman et al. (2007) Institute of Medicine: Preterm Birth: Causes, Consequences, and Prevention, Born Too Soon; BCG analysis
2010 preterm births ('000)
748
774
3,519
1,172
0
Nigeria
China
India
Pakistan
Indonesia
USA
Bangladesh
Philippines
Dem Rep Congo
Brazil
1,000 3,0002,000 4,000
676
517
424
349
341
279
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1.1 million preterm deaths each year
> 125 deaths per hour = Commercial liner crashing every 3 hours
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Neonatal mortality is declining slower than childmortality and prematurity is the 2nd leading causeof under-5 deaths
Source: Lawn J E et al. Health Policy Plan. 2012;27:iii6-iii28; Liu L et al. Lancet.2012; 79(9832):2151-61.
Neonatal mortality is not dropping as fastas under-five mortality
2010 Childhood Mortality40% Neonatal PeriodPreterm birth is the #2 causeof U5 death
Other
27%
Preterm
15%
35%
23%
Infection
Intrapartum
Under 5 Mortality Neonatal Mortality
Infection includes: sepsis, pneumonia, tetanus and diarrhea
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Long-term impact of preterm birthon survivors
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Long-term outcomes
Specific physical effects Visual impairment Hearing impairment Chronic lung disease of prematurity
Long-term cardiovascular ill-health andnon-communicable disease
Neuro-developmental/behavioral effects
Mild: disorders of executive functioning Moderate to severe: global developmental
delay
Psychiatric/behavioral sequalaeFamily, economic and societaleffects
Impact on family Impact on health service Intergenerational
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Born Too Soon The Global Action Report on
Preterm Birth
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Born Too Soon - a truly global report
First global estimates of preterm birth rate for184 countries with WHO (Lancet, 2012)
> 50 partner organizations including
45 authors from 11 countries includingscientists, epidemiologists, clinicians, parents
Linked to Every Woman Every Child, andforward by UN Secretary General Ban Ki-Moon
Free at www.who.int/pmnch/media/news/2012/preterm_birth_report/en/index.html
Professionals, policymakers and parents
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Two groups formed to channel momentumfrom Born Too Soon into actionable steps
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Research Group
Purpose: Develop a pretermresearch solution pathway
Core Conveners: NICHDGAPPS, MOD, BMGF, WHO@ Researchers
Next steps: Convene a
funders meeting in summer2013 to coordinate globalpreterm funding efforts
Care Group
Purpose: Accelerateimplementation of priorityinterventions
Core Members: UNICEF,WHO, SNL, USAID, BMGF,CIFF, AAP/IPA, PMNCH
Next steps: Efforts feedinginto Global Newborn
Actionwith a Plan to be
launched later this year
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What: A global movement to accelerate access to simple, cost-effective solutions, andsupport families who have experienced preterm birth.
Who: > 55 global partners and > 60 countries, all continents, media reach of 1.4 billion
High income countries, e.g. Illumination Initiative for famous buildings
Malawi: high level event, commitment made
Uganda: high level event with Minister of Health, commitment made for
KMC and ACS scale up
India: Global KMC meeting in Ahmedabad, India, etc
www.facebook.com/worldprematurityday
#Borntoosoon
#WorldPrematurityDay
Global twitter relay
28 million reached
http://www.facebook.com/worldprematuritydayhttp://www.facebook.com/worldprematurityday -
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Outline
Preterm burden
Implementation &research horizons
Purpose-driven, catalytic partnerships
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Priority interventions -'tip of the spear' todrive maximal impact
ANCS
KMCNeonatal
resuscitation
Infection case
management
CPAP / novel
surfactant
Utilize high impact
priority interventions
to drive a wedge...
...for other critical
interventions to be
implemented in a
package...
...and to provide the
platform for implementing
future innovations
Cervical
pessary
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Kangaroo mother care
Skin-to-skin with mother 24 hours a day providing:
Exclusive breastfeeding
Supportive care for the mother infant dyad
Improved mortality (LMIC: RR 0.58, 95% CI 0.37-0.9 @ 40/41 or discharge)
Reduced infections (LBW: 7.2% vs. 12.6% RR 0.57, CI: 0.4-0.8 @ 6/12)
Improved infant growth (Weight: MD 3.9g/day; Length: MD 0.29cm/day; HC:0.18cm/week)
Reduced hypothermia (RR 0.23, 95% CI 0.1-0.55)
Mothers more likely to breastfeed @ 3/12 (RR 1.2, 95% CI 1.01-1.43)
Earlier discharge (2.4 days on average)
Increased maternal infant attachment (24 vs. 18)Effective entry point for care of small babies
Lawn et al Kangaroo mother care to prevent neonatal deaths due to preterm birth complications. Int J Epid: 2010,Conde-Agudelo A, Belizan JM, Diaz-Rossello, Cochrane Review: 2011
Could save an estimated 450,000 babies by 2015if 95% of preterm babies are reached
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We are working to overcome barriers towider use of Kangaroo Mother Care
Barrier Action
Factional and uncoordinated globalcommunity. ? Over-medicalization bythe medical profession, creating theperception that KMC is so hard,babies are so fragile, KMC must be
done just right, and are babiessafe resulting in making KMC so
complex
Conduct faction analysis, partner landscaping and apply a systemsapproach
Catalyze coordinated thinking, communication and action amongpartners, and align around common goals
Elaborate the fact base for KMC and identify points of alignment
vs. points of contention
Lack of cohesive national policieswith quality control and M&Ecomponents
Integrate recordkeeping and reporting on KMC into routinemonitoring and evaluation systems
Countries self-selected to become champions
Lack of integration - KMC oftenlimited to referral centers
Promote a KMC continuum of care culture and framework
Limited demand among families forpostnatal services
Promote early care-seeking through community engagement Understand social support needs of moms and families to practice
KMC
Sources: MCHIP, Save the Children (2012). Tracking Implementation Progress for Kangaroo Mother Care.
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Groundswell of newborn community askingquestions of KMC and building momentum
WHO CHNRI Exercise, KMC was Top of the list for preterm birth questions
Among top 10 newborn research priorities
Evaluate the effectiveness, safety and cost of community-based initiationof KMC to improve survival and health outcomes of clinically stable
preterm and LBW babies
Evaluate strategies for scale up of facility-based initiation of KMC for
preterm and LBW babies on their survival, health and long-term
outcomes such as school-performance
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We are working to overcome contextualbarriers to wider use of antenatalcorticosteroids
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Barrier Action
Lack of awareness,knowledge, guidelines & localregulations about who canadminister drug; lack ofand/or belief among
healthcare providers
Application to add to WHO Essential Medicines List Policy brief for use at country level Frequently asked questions to dispel myths Online portal for quick reference to key information In-country education and training
Lack of supply at the rightplace and right time
Identification of multiple, low cost (
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We are working with research and funding partnersto map out a preterm solution pathway to coordinateour efforts Research group
Discovery Development Delivery
ProgesteroneRequires tools to enable deployment &
user friendly formulation
Cervical pessaryVery promising but requires validation
and tools to enable deployment
Institutional KMCRequires effort to drive uptake
CPAPRequires adaptation for
use in low resource settings
Novel surfactantRequires more user
friendly & inexpensive formulation
Prevent
preterm
births
Careforthe
pretermb
aby
Predict
pretermb
irths Understand
etiopathogenesisof PTB &develop
interventions to
predict andprevent PTBs
Requires clearly
defined research
agenda and more
traction from research
and funding
communities
Cervical length measurementRequires dev of suitable methods for
use in low resource settings
PTB biomarkersRequires validation of high potential
options and dev. of field ready Dx
Fetal FibronectinMainly used to rule out PTB,
has low positive predictive value
Assessment of prior PTB hxRequires dev. of suitable methods for
use in low resource settings
Antenatal CorticosteroidsRequires effort to drive uptake
Community KMCBeing implemented in select locations but still requires
more operational research before widespread uptake
Socialfactors
e.g. stress
Care group
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Preterm birth research horizons tofill the gaps of known interventionsBiomarkers, proteomics, pessaries, progesterone.
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First published RCT assessing use of cervicalpessary in PTB showed efficacy on all end points
Women with cervical length 25mm
randomized to pessary or control
Meaningful efficacy seen on all
pregnancy and neonatal outcomes
Relative Risk
Composite
1.00.50.0
Sepsis Rx
RDS
BW < 2500 g
BW < 1500 g
PTB < 37 wksPTB < 34 wks
PTB < 28 wks 0.25 [0.09-0.73]
0.24 [0.13-0.43]
0.36 [0.27-0.49]
0.35 [0.17-0.72]
0.30 [0.18-0.50]
0.22 [0.08-0.56]
0.25 [0.07-0.87]
0.17 [0.07-0.42]
Pregnancy
Neonatal
Source: Goya et al. Lancet (2012): Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial, Data from Goya et al study convertedinto relative risk and 95% CI using online calculator from Centre for Evidence Based Medicine, Toronto which is accessible at http://ktclearinghouse.ca/cebm/practise/ca/calculators/statscalcBCG analysis
While impressive, consensus is that more trials are needed to confirm RCT findings
726 women withcervix 25mm
192 assigned tocervical pessary
193 assigned toexpectant mgt.
190 included inintention-to-treat
analysis
190 included inintention-to-treat
analysis
341 opted out
2 lost to follow up 3 lost to follow up
385 randomlyassigned
http://ktclearinghouse.ca/cebm/practise/ca/calculators/statscalchttp://ktclearinghouse.ca/cebm/practise/ca/calculators/statscalc -
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Cochrane meta-analysis by Dodd et al. showed benefit ofprogesterone1 in women with different PTB risk profiles
1.0
Relative Risk
0.8
PTB < 37 wks
0.60.40.20.0
Risk of tocolysis
Neonatal sepsis
BW < 2500 g
PTB < 37 wks
PTB < 34 wks
PTB < 34 wks
Short cervix2
PTB history
Multiple pregnancy
RR 0.58 [0.38-0.87]
RR 0.28 [0.08-0.97]
RR 0.15 [0.04-0.64]
RR 0.80 [0.70-0.92]
RR 0.64 [0.49-0.83]
RR 0.75 [0.57-0.97]
Threatened PT laborRR 0.29 [0.12-0.69]
[95% CI]
1. Cochrane review did not differentiate between subtypes of progesterone (natural progesterone vs. synthetic 17-alpha-hydroxyprogesterone caproate (17P)). 2. Short cervix definition varies, andCochrane review included only cervical length < 15 mmSource Dodd et al. Cochrane Library (2012), Romero. Women's Health (2011), BCG analysis
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The late preterm @ 32-36 weeks (85% of PTB) moreprone to adverse effects than @ 40 weeks
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Outline
Preterm burden
Implementation & research horizons
Purpose-driven, catalyticpartnerships
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We cannot view newborn health inisolation. We must take a holistic,
panoramic view involving catalyticpartnerships
Partnerships can lead
to better, faster,greater healthoutcomes within the
context of healthy andproductive families
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What Can You Do?
1. Policy: include newborn and preterm birth in policyframeworks
2. Program: ANCS & KMC; measure, quality of care
3. Form purpose-driven partnerships: across RMNCH,nutrition, malaria, education
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The task is not impossible
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A single spider weaves
a web and catches one fly,
Many spiders weave a web and
catch an elephant.
-Ghanaian proverb
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Thank You
2013 Bill & Melinda Gates Foundation. All Rights Reserved.Bill & Melinda Gates Foundation is a registered trademark in the United States and other countries.