Evaluation of a cluster-randomized controlled trial of a package of community-based maternal and newborn interventions in Mirzapur, Bangladesh.

Gary L Darmstadt,Peter J Winch,Derrick Crook,Habibur Rahman Seraji,Shams E Arifeen,Robert E Black,Saifuddin Ahmed,Sanwarul Bari,Ishtiaq Mannan,Yoonjoung Choi,A S M Nawshad Uddin Ahmed,Nazma Begum,Syed M Rahman,Mathuram Santosham,Samir K Saha,Anne C C Lee,Abdullah H Baqui,Jose M Belizan

doi:10.1371/journal.pone.0009696

Abstract

BackgroundTo evaluate a delivery strategy for newborn interventions in rural Bangladesh.MethodsA cluster-randomized controlled trial was conducted in Mirzapur, Bangladesh. Twelve unions were randomized to intervention or comparison arm. All women of reproductive age were eligible to participate. In the intervention arm, community health workers identified pregnant women; made two antenatal home visits to promote birth and newborn care preparedness; made four postnatal home visits to negotiate preventive care practices and to assess newborns for illness; and referred sick neonates to a hospital and facilitated compliance. Primary outcome measures were antenatal and immediate newborn care behaviours, knowledge of danger signs, care seeking for neonatal complications, and neonatal mortality.FindingsA total of 4616 and 5241 live births were recorded from 9987 and 11153 participants in the intervention and comparison arm, respectively. High coverage of antenatal (91% visited twice) and postnatal (69% visited on days 0 or 1) home visitations was achieved. Indicators of care practices and knowledge of maternal and neonatal danger signs improved. Adjusted mortality hazard ratio in the intervention arm, compared to the comparison arm, was 1.02 (95% CI: 0.80–1.30) at baseline and 0.87 (95% CI: 0.68–1.12) at endline. Primary causes of death were birth asphyxia (49%) and prematurity (26%). No adverse events associated with interventions were reported.ConclusionLack of evidence for mortality impact despite high program coverage and quality assurance of implementation, and improvements in targeted newborn care practices suggests the intervention did not adequately address risk factors for mortality. The level and cause-structure of neonatal mortality in the local population must be considered in developing interventions. Programs must ensure skilled care during childbirth, including management of birth asphyxia and prematurity, and curative postnatal care during the first two days of life, in addition to essential newborn care and infection prevention and management.Trial RegistrationClinicaltrials.gov NCT00198627

Highlights

Neonatal deaths account for almost half of under-5 child deaths in Bangladesh and efforts to reduce neonatal mortality are crucial to achieving Millennium Development Goal 4 for child survival.[1,2,3,4]
We developed a preventive service delivery strategy in a rural area of central Bangladesh with good access to facilitybased care to promote household newborn care practices through home visits by community health workers (CHWs), and conducted routine, home-based illness surveillance coupled with facilitated referral of sick newborns to health facilities
Percent of home-born newborns assessed by CHWs within the first two and seven days of life improved from 54% to 69% and from 66% to 74%, respectively, over the survey periods

Summary

Introduction

Neonatal mortality declined by approximately 20% over the last decade in Bangladesh, the rate of decline was less than in the postneonatal and 1–4 year-old periods.[1,2] Neonatal deaths account for almost half of under-5 child deaths in Bangladesh and efforts to reduce neonatal mortality are crucial to achieving Millennium Development Goal 4 for child survival.[1,2,3,4] Since90% of births and most neonatal deaths still occur at home,[1,3] community-level interventions must be introduced while linking with the healthcare system for treatment of life-threatening newborn illness.[5,6,7,8,9]Several recent community-based trials of packages of maternal and neonatal interventions in low resource settings in South Asia have shown statistically significant reductions in neonatal mortality, employing a variety of healthcare delivery approaches. 90% of births and most neonatal deaths still occur at home,[1,3] community-level interventions must be introduced while linking with the healthcare system for treatment of life-threatening newborn illness.[5,6,7,8,9]. Home-based health education and routine neonatal assessment and antibiotic treatment of serious infections by community health workers (CHWs) decreased mortality in rural India[10,11] and rural northeastern Bangladesh,[12] regulatory approval for and availability of CHWs for home-based treatment of illness is lacking in most settings. To evaluate a delivery strategy for newborn interventions in rural Bangladesh

Methods

Results

Discussion

Conclusion