NEWHINTSTesting a community based Testing a community based intervention to reduce neonatal intervention to reduce neonatal deaths in rural Ghana deaths in rural Ghana

NEWHINTS Trial: NEWHINTS Trial: COLLABORATIONKHRC: 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 Research

Centre

Save the

Children Saving

Newborn

Lives

London School

of Hygiene &

Tropical

Medicine

World Health

Organication

Department for

International

Development

Ghana Health

Service

Newborn Home Intervention Study- NEWHINTS -

Cluster randomised trial to evaluate impact of routine home visits by CBSVs on neonatal mortality in rural Ghana

Primary objectivesPrimary 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 objectivesSecondary 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 age- and cause-specific neonatal mortality

Setting: Brong Ahafo RegionSetting: Brong Ahafo Region

Kintampo North

Kintampo South

Nkoranza

Tain

Wenchi

Techiman

Baseline dataBaseline 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%

OverallOverall designdesign

• Formative research• Development of intervention• Development of evaluation plan• Implementation and evaluation of

intervention (cluster randomised trial)

Formative research 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 behaviorsTarget 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 skin-to-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 Delivery channel

• Home visits from community health workers (community based surveillance volunteers)

• District health management team supervision

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 Intervention design

Strengthening DHMTs

Intervention designIntervention designAn Integrated Intervention PackageAn Integrated Intervention Package

CBSVs

CounselWomen

(& families)

Assess& Refer

Newborns

5 HOME VISITS

HospitalENC

Strengthening

Training

Incentives

Supervision

Ensureconsistent

advice

TBASensitisation

CommunitySensitisation

HealthFacility

Sensitisation

Materials

Five focused home visitsFive focused home visits1. Early

pregnancyBirth 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 signsRefer very LBW & sick babies to hospitalEncourage exclusive BF; Reduce bathingSpecial care for LBW babies

4. Day 3 Assess baby for danger signs & Refer sick babiesReinforce EBFTeach danger signs & encourage prompt careseeking

5. Day 7 Assess baby for danger signs & Refer sick babiesReinforce EBF, prompt careseekingEncourage bednet use, immunisations

Five focused home visitsFive focused home visits

PLUSPLUS 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:Evaluation design:Cluster randomised trialCluster 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 designEvaluation design

Outcome

Process

Outcome evaluation design Outcome evaluation design - How- 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 - WhatOutcome 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 & evaluationProcess 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 & evaluationProcess 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

TimescaleTimescale 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:IF IT WORKS: Expand to control zones Scale-up (Region, rest of Ghana, sub-Saharan Africa)

Thank youThank you