1. Newborn health packages and priorities to save lives NOW Ms Kate Kerber Dr Joy Lawn Saving Newborn Lives / Save the Children-US Funded by The Bill & Melinda Gates Foundation GHANA ACADEMY OF ARTS AND SCIENCES Promoting Excellence in Knowledge

2. Outline Description of the problem Delivery in the real world Solutions for the 3 main causes of death: infections, preterm, intrapartum-related Integrated MNCH packages Development of new or adapted interventions to reduce the cost, increase effect, improve deliverability of newborn care Discovery New science around the mechanisms and causes of neonatal illness

3. DESCRIPTION Where, When and Why do African Newborns Die?

4. Where do 1.2 million African newborns die? More than 18 million births at home each year in Africa Most deaths also occur at home - unnamed and uncounted Affects data availability but also the priority given Over one quarter of under-five deaths in Africa are newborns 900,000 stillbirths still largely missing

5. Up to 50% of neonatal deaths are in the first 24 hours 75% of neonatal deaths are in the first week Source: Lawn JE, Kerber K Daily risk of death in Africa during first month of life based on analysis of 19 DHS datasets (2000 to 2004) with 5,476 neonatal deaths Birth and first week is key: when most babies die yet when coverage of care is lowest for mothers and babies When do African newborns die?

6. Infections 39% Source: Opportunities for Africa’s Newborns, 2006. Based on vital registration for one country and updated modelling using the CHERG neonatal methods for 45 African countries using 2004 birth cohort, deaths and predictor variables. Why do African newborns die? 3 causes account for 88% of neonatal deaths

7. Paradoxical opportunity at highest mortality rates Infections ~ 15% of neonatal deaths when NMR is less than 15 per 1000 Infections ~50% of neonatal deaths when NMR is over 45 per 1000 Source: Lawn JE, Cousens SN, Zupan J Lancet 2005. based on cause specific mortality data and estimates for 192 countries 46%| 52% | 88% | 99% Median coverage of skilled attendance Higher mortality rate = faster possible reduction and greater effect on inequity

8. DELIVERY of solutions for neonatal sepsis THE BURDEN ~370,000 neonatal deaths in Africa each year, plus ~70,000 due to neonatal tetanus Many of the deaths are among preterm babies Acute morbidity and long term disability - no systematic estimates yet

9. Prevention Antenatal care: Coverage high but quality gap high Intrapartum and postnatal care: hygienic care at birth lacking, some harmful practices around cord care, early and exclusive breastfeeding low Case management Physical, cultural barriers to accessing early care 39/68 Countdown countries have adapted IM‘N’CI Lack of capacity (staff, drugs, supplies) Policy barriers for what to give, where and by whom, e.g. “gold standard” antibiotic regimen which may block community-based treatment Coverage and constraints –neonatal infections Urgent need for alternative antibiotic regimen / delivery strategy

10. Scaling up sepsis case management – research questions Are shorter course or switch course antibiotics, or oral-only antibiotic regimens effective? New multi-site study in Pakistan, Bangladesh but no African site. Can we develop an algorithm to screen newborns needing antibiotic treatment when identified through active surveillance? What are the optimal, locally adapted delivery approaches for newborn infection management as part of community-based packages? Source: Bahl et al Pediatr Infect Dis J. 2009 Jan;28(1 Suppl):S43-8. Need for health systems / policy research to address existing preventive home practices and evaluation, costing for facility interventions and quality improvement (PIDJ 2009)

11. DELIVERY of solutions for preterm birth complications THE BURDEN ~290,000 neonatal deaths in Africa each year Preterm babies are also at greater risk of death due to infections Acute morbidity and long term disability - no systematic estimates yet

12. Priorities for reducing preterm deaths No effective primary prevention of preterm labour, some effect through addressing malaria and other maternal infections during pregnancy Antenatal steroids Extra care of preterm babies including clean, safe delivery, support for breastfeeding and thermal care, and Kangaroo Mother Care Early treatment and care for complications such as breathing problems, and infections The average baby born 28-31 weeks gestation in USA costs $95,000 in medical care in first year: More than 10x average African per capita income

13. Coverage and constraints – preterm complications Prevention Large gains in coverage for malaria IPTp but effect small Antenatal steroids – major effect but very low coverage Traditional practices can be barriers to improved simple care – thermal care and immediate, exclusive breastfeeding Case management Kangaroo Mother Care – new meta-analysis revealing large mortality effect‏, BUT: Coverage is low - often only available at referral centres Lack of knowledge and acceptance by hospital/ admin staff Lack of capacity - trained staff, supervision

14. Newspaper headline August 2007 Knowledge ≠ implementation Kangaroo Mother Care Effective, low cost care for preterm babies (Cochrane review)‏

15. Scaling up KMC – research questions Services closer to home –Some governments would like to expand KMC to district hospitals and health centres (e.g. Malawi, Tanzania, Mali)‏ –Evidence for community initiation/continuation of KMC? Novel approaches to counteract staff shortages in facility (e.g. task shifting and use of patient attendants)‏ Training and tracking –Shorter, integrated off-site training –1-2 day workshops for district officials, implementers –On-site facilitation and support –Consistent indicators and measuring scale up Large scale implementation is possible, with training either on site or at centre of excellence, but facilitation/mentoring is crucial

16. DELIVERY of solutions for intrapartum- related neonatal deaths (“birth asphyxia”) THE BURDEN ~290,000 neonatal deaths in Africa each year +18 million home births Acute morbidity and long term disability - no systematic estimates yet

17. “Birth Asphyxia” language “Asphyxia” is imprecise and poorly defined - recommended term is intrapartum-related neonatal deaths and refers to neonatal deaths in term babies with evidence of intrapartum injury Most of the evidence relates to “not breathing at birth” – new meta- analysis suggests possible 35% reduction in mortality for babies not breathing at birth (Lee, Lawn et al, unpublished)‏

18. Priorities for reducing intrapartum-related deaths Prevention Prevention through antenatal care including management of pre-eclampsia and multiple pregnancy Skilled care at birth Basic and comprehensive emergency obstetric care Case management Resuscitation Care of babies with neonatal encephalopathy

19. Prevention Antenatal care –Quality gap, e.g. identifying abnormal lie, and early booking –Birth preparedness and danger signs Intrapartum care: community empowerment and financial schemes to improve skilled care coverage, task shifting Case management Even where more births are in health facilities, neonatal resuscitation may be low Lack of capacity (competent staff)‏ Lack of supplies especially bag and mask Intrapartum-related neonatal deaths - coverage and constraints Basic newborn resuscitation is life saving and feasible, less than 1% need advanced resuscitation

20. Neonatal resuscitation People –Competency training, refresher courses, supervision –Task shifting to community: Promising, but more evaluation required Devices –Bag and mask –Suction devices –Training mannequins Post-resuscitation care –Pulse oximeters –Oxygen condensers New Laerdal “NeoNathalie” is 80% lower cost Source: Joy Lawn, American Academy of Pediatrics, 2009 Helping Babies Breathe training, Tanzania

21. DELIVERY of integrated MNCH packages to reduce neonatal deaths

22. Reaching 90% of women and babies with 16 proven interventions delivered through health packages could reduce neonatal mortality by up to 67% saving up to 800,000 lives per year. Potential neonatal lives saved and additional cost of health system packages LIVES Additional cost of providing these interventions is US$1 billion annually or US$1.30 per capita. Two- thirds of this cost will also benefit mothers and older children. COST Source: Darmstadt et al Saving Newborn Lives in Asia and Africa: cost and impact of phased scale-up of interventions. HPP. Feb 2008 Approximately one-third of newborn deaths could be prevented just through achievable coverage increases of context-specific interventions in two years, the main question is HOW to deliver.

23. Single interventions with some evidence of benefit for neonatal outcomes Source: Hawes R et al Impact of packaged interventions on neonatal health: a review of the evidence. HPP. May 2007 Antenatal (22)‏ Intrapartum (13)‏ Postnatal (22)‏

24. Childhood Newborn/postnatal Pre-pregnancy Pregnancy Birth Outreach/outpatient ANTENATAL CARE –Focused 4-visit ANC, including: hypertension/pre- eclampsia management tetanus immunisation syphilis/STI management IPTp and ITN for malaria PMTCT for HIV/AIDS Family/community –Knowledge newborn care and breastfeeding –Emergency preparedness –Healthy home care including: promotion of exclusive breastfeeding, hygienic cord/skin care, warmth, danger sign recognition and careseeking for illness – Where referral is not available c onsider case management for pneumonia, neonatal sepsis –Where skilled care is not available, clean delivery and immediate newborn care including hygiene, warmth and early initiation of breastfeeding Clinical CHILDBIRTH CARE –Emergency obstetric care –Skilled obstetric care and immediate newborn care (hygiene, warmth, breastfeeding) and resuscitation, PMTCT EMERGENCY NEWBORN CARE - Integrated management of childhood illness (IMNCI)‏ –Extra care of preterm babies including kangaroo mother care –Emergency care of sick newborns POSTNATAL CARE –Promotion of healthy behaviours –Early detection and referral of complications – Extra care of LBW babies – PMTCT for HIV Newborn lives saved at 90% coverage of packages Childbirth care 27% (18-35%)‏ reduction in NMR Postnatal care 29% (17-39%)‏ reduction in NMR 14-32% NMR reduction 10-30% NMR reduction 26-51% NMR reduction Antenatal care 8% (6–9%)‏ reduction in NMR Source: Lawn JE DCP chapter adapted for Lancet neonatal series executive summary

25. Family/community Outreach/outpatient Clinical ANTENATAL CARE - 4-visit focused package - IPTp and ITN for malaria - PMTCT for HIV/AIDS POSTNATAL CARE –Promotion of healthy behaviours –Early detection /referral of illness –Extra care of LBW babies –PMTCT for HIV –Knowledge newborn care and breastfeeding –Emergency preparedness Healthy home care including: -newborn home care of babies (hygiene, warmth), - - nutrition including exclusive breastfeeding and appropriate complementary feeding - seeking appropriate preventive care –danger sign recognition and careseeking for illness –Oral rehydration salts for prevention of diarrhoea –Where referral is not available consider case management for pneumonia malaria, neonatal sepsis –Where skilled care is not available, clean delivery and immediate newborn care including hygiene, warmth and early initiation of breastfeeding –Adolescent and pre-pregnancy nutrition –-Education –Prevention of HIV and STIs CHILD HEALTH CARE –Immunisations, nutrition eg Vit A and growth monitoring –Malaria ITN –Care of children with HIV including cotrimoxazole –First level assessment and care of childhood illness (IMCI) CHILDBIRTH CARE –Emergency obstetric care –Skilled obstetric care and immediate newborn care (hygiene, warmth, breastfeeding) and resuscitation –PMTCT EMERGENCY NEWBORN AND CHILD CARE - Hospital care of childhood illness and children with HIV using Integrated management of Childhood Illness principles (IMNCI) –Extra care of preterm babies including kangaroo mother care –Emergency care of sick newborns REPRODUCTIVE - Post-abortion care, TOP where legal - STI case mx REPRODUCTIVE HEALTH CARE - Family planning - Prevention & management of STI & HIV - Folic acid Intersectoral Improved living conditions – Housing, water and sanitation, nutrition Education and empowerment FAMILY AND COMMUNITY Source: Lawn JE DCP chapter adapted for Lancet neonatal series executive summary Childhood Newborn/postnatal Pre-pregnancy Pregnancy Birth Childbirth care Postnatal care Antenatal care Adol- escent health Child health care Family planning Adol- escent & school programs Antenatal care Emergency obstetric and neonatal care Skilled attendance Sick baby and child care in hospital IMCI PMTCT of HIV Malaria programmes Nutrition programmes Routine Postnatal care Behaviour change and community mobilisation, community IMCI Reality for integrated service delivery

26. 1.Routine postnatal care for mother and baby 2.Treating neonatal infections (and maternal postnatal complications) especially where referral is not possible 3.Extra care of preterm babies in the community, and linking to improved facility care, KMC 4.Integrated service delivery in practice, e.g. in settings with high HIV/AIDS prevalence through PMTCT and early feeding support 5.Improved facility-based care, especially improved neonatal care at district hospital level Priorities for DELIVERY research for health system packages Priority for implementation research: Answering HOW and WHO and WHERE questions

27. Integrated postnatal care – where and when? Neonatal mortality rate Early postnatal visits reduce newborn deaths. A first visit within 2 days of birth may reduce deaths by 67%. Need to test integrated, scaleable packages, especially in Africa as the cadre and package content will vary. Baqui A et al. Effect of timing of first postnatal care home visit on neonatal mortality in Bangladesh, BMJ 2009. Evidence from Bangladesh: 3 arm RCT with >10,000 births, baseline neonatal mortality rate 41 per 1000 live births New consensus statement on home visits: mothers and newborns to be visited within 24 hours and again on day 3 and day 7 if possible, by health professionals or appropriately trained CHW.

28. Major impact is achievable through community intervention packages In high NMR settings (>60), up to 50% decline can be achieved through behaviour change / community mobilisation, even without antibiotics or other “medical” care HOWEVER Only 2 are in the public sector and several do not link to the health system Only 2 have cost data published and these are not comparable THEREFORE Packages need adaptation and assessment in Africa Must consider getting to scale in the design, including comparable cost Operationalise links with the health system, especially in African context Lessons learned from newborn health research in Asia

29. 1.Co-funding with WHO, DfID 2.Co-funding with CDC and UNICEF Mali (OR) Ethiopia (RCT) ‏ Tanzania INSIST (RCT)‏ Uganda UNEST (RCT)‏ Ghana NEWHINTS (RCT) 1 South Africa Goodstart III (RCT) 2 Malawi (OR – district scale up with MoH)‏ Mai Mwana (RCT) Mozambique (OR)‏ Adapting, testing and costing community-based, integrated newborn health packages in Africa RCT = Randomized Control Trial OR = Operations Research

30. DEVELOPMENT and DISCOVERY research

31. Treatment switch regimens and shorter courses New antibiotics, especially oral Improved technology for facility care, especially oxygen use and monitoring New/improved prevention strategies (e.g. chlorhexidine wipes)‏ Vaccines? Development and discovery: Neonatal infections Source: Lawn JE, Rudan I, Ruben C. Four million newborn deaths: is the global research agenda evidence based? EHD 2008

32. Use of emollients in low level care / at home Antenatal steroid use – reduced cost / complexity Surfactant use in low-income settings CPAP, district hospital level care Adapted simpler, robust technology, e.g. pulse oximeters and syringe drivers Discovery: Prevention of preterm birth Source: Lawn JE, Rudan I, Ruben C. Four million newborn deaths: is the global research agenda evidence based? EHD 2008 Development and discovery: Preterm complications

33. Simpler approaches and robust technology needed: Intrapartum care, e.g. doppler fetal heart monitors Neonatal resuscitation Care of babies with neonatal encephalopathy (e.g. head cooling)‏ Use of cell phones/other communication technology for emergency transport Discovery: Simpler, specific identification of fetal distress Addressing the synergies of infection and intrapartum hypoxic insult Source: Lawn JE, Rudan I, Ruben C. Four million newborn deaths: is the global research agenda evidence based? EHD 2008 Development and discovery: intrapartum-related neonatal deaths

34. Conclusion Three preventable causes account for 88% of newborn deaths in Africa. Up to 800,000 newborn deaths could be prevented if essential care reached 90% of mothers and babies – how to deliver care to those who need it most. All types of research are required, but systematic pipeline (D-D-D-D) addressing priority questions would be more productive. Breakthroughs in development and discovery research could significantly accelerate progress – science in action.