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NEWHINTS Testing a community based intervention to reduce neonatal deaths in rural Ghana NEWHINTS Trial: COLLABORATION KHRC: Alex Manu; Charlotte Tawiah; Seth Owusu-Agyei; Ben Weobong; Thomas Gyan; Sammy Danso LSHTM: Betty Kirkwood; Zelee Hill (now ICH); Karen Edmond; Seyi Soremekun; Guus ten Asbroek DHMTs: 6 districts GHS HQ: Isabella Sagoe-Moses; Patrick Aboagye; Frank Nyonator Funders: SNL + WHO + DFID Kintampo Health Save the Children London School of World Health Department for Ghana Health Research Centre Saving Newborn Hygiene & Organication International Service Lives Tropical Medicine Development Newborn Home Intervention Study - NEWHINTS Cluster randomised trial to evaluate impact of routine home visits by CBSVs on neonatal mortality in rural Ghana Primary objectives To develop a feasible and sustainable intervention to improve newborn care practices through routine home visits in pregnancy and the first week of life To evaluate the impact of these home visits on all cause neonatal mortality To evaluate their impact on newborn care practices To evaluate the cost-effectiveness of the intervention Secondary objectives To assess the coverage and quality of the service provided and the family and community response to the service To evaluate whether the intervention reduces socio-economic inequalities in neonatal mortality, and in access to key interventions To evaluate the impact of the intervention on ageand cause-specific neonatal mortality Setting: Brong Ahafo Region Kintampo North Tain Kintampo South Wenchi Nkoranza Techiman Baseline data • 18,000 pregnancies: 15,000 live births/year • Stillbirth rate: 34.0 /1000 live and stillbirths • Perinatal mortality rate: 55.1 /1000 live and stillbirths • Neonatal mortality rate: 30.3 /1000 live births • Maternal mortality ratio: 397 /100,000 live births • Home deliveries: 50.3% Overall design • • • • Formative research Development of intervention Development of evaluation plan Implementation and evaluation of intervention (cluster randomised trial) Formative research • Families, Range of health care providers – Literature review – Focus group discussions – In depth interviews – Birth narratives – Participant observation – Facility surveys – Quantitative data analysis Target behaviors Attend antenatal care, including in early pregnancy Deliver in a health facility Prepare for the birth: Facility birth: transport, supplies, financial plan Home/impromptu birth: clean delivery, extra birth assistant to vigorous dry and wrap the baby Breastfeed as soon as the cord is cut and place baby skinto-skin with mother Bath baby quickly, with warm water and dry immediately Keep small babies skin-to-skin, do not bath, feed every 2 hours, & wash hands Care seeking for pregnancy, delivery, post partum & neonatal danger signs Delivery channel • Home visits from community health workers (community based surveillance volunteers) • District health management team supervision Intervention design Focus on prevention Give simple messages through a story for behaviours where knowledge is the key barrier Counsel/problem solve for behaviours which require negotiation Not direct health care Refer and facilitate referral when necessary Intervention design An Integrated Intervention Package TBA Sensitisation Materials Counsel Women (& families) Training CBSVs 5 HOME VISITS Incentives Community Sensitisation Assess & Refer Newborns Health Facility Sensitisation Supervision Strengthening DHMTs Hospital ENC Strengthening Ensure consistent advice Five focused home visits 1. Early pregnancy Birth preparedness: Promote facility delivery, planning for delivery, saving for emergencies, bednets, ANC. 2. 3rd trimester Dry, wrap & breastfeed immediately after delivery (plus 2nd assistant during delivery) 3. Day of birth Weigh and assess the baby for danger signs Refer very LBW & sick babies to hospital Encourage exclusive BF; Reduce bathing Special care for LBW babies 4. Day 3 Assess baby for danger signs & Refer sick babies Reinforce EBF Teach danger signs & encourage prompt careseeking 5. Day 7 Assess baby for danger signs & Refer sick babies Reinforce EBF, prompt careseeking Encourage bednet use, immunisations Five focused home visits PLUS Follow-up visits for referred babies Visit at 14 days for very LBW babies • Health cards used to assist with each home visit Evaluation design: Cluster randomised trial 98 “Newhints” zones in the 6 districts: Area covered by 1 supervisor (8-10 CBSVs) 49 Intervention zones: Newhints package 49 Control zones: CBSVs continue as usual (eg. encouraging families to attend on child health days) 18,000 pregnancies/year; 15,000 live births 80% power to detect 25% reduction in neonatal mortality Analysis: Intention to treat Evaluation design Outcome Process Outcome evaluation design - How Outcomes Independent to intervention implementation 4-weekly home visits of all women in trial districts (intervention and control) Additional visit after all neonatal deaths (for verbal post mortem) Outcome evaluation - What Mortality outcomes All neonatal deaths Causes of death Timing of death Neonatal care practices Facility delivery, EBF, Drying, Wrapping, Bathing, BF, Care seeking, Bednets Access / coverage (quantitative) No and timing of visits from CBSV Process monitoring & evaluation Sub-samples from Newhints zones – In-depth interviews with mothers exploring practices in detail (constraints, facilitating factors & in Newhints zones role of CBSV) – Some quantitative data collection (eg. cost data) Special sub-samples from Newhints zones to explore whether mothers carried out advice on: – Special care for LBW babies inc. SSC – Referrals Process monitoring & evaluation Delivery channel, CBSVs, Supervisors, DHMTs In depth interviews Perceptions and feedback, Supervision, Workload, Referrals Data collection Log books , Referral outcome, Supervisor reports, Staff turnover Cost effectiveness Timescale July 2008: Intervention fully implemented Evaluation: Babies born 1 July 2008 - 30 June 2009 18,000 pregnancies/year; 15,000 live births 80% power to detect 25% reduction in neonatal mortality Aug 2009: end of data collection Analysis: Intention to treat Nov 2009: main results IF IT WORKS: Expand to control zones Scale-up (Region, rest of Ghana, sub-Saharan Africa) Thank you