Predicting the potential impact of scaling up four pneumonia interventions on under-five pneumonia mortality: A prospective Lives Saved Tool (LiST) analysis for Bangladesh, Chad, and Ethiopia.

Background: Pneumonia remains the leading cause of mortality in under-five children outside the neonatal period. Progress has slowed down in the last decade, necessitating increased efforts to scale up effective pneumonia interventions. Methods: We used the Lives Saved Tool (LiST), a modelling software for child mortality in low- and middle-income settings, to prospectively analyse the potential impact of upscaling pneumonia interventions in Bangladesh, Chad, and Ethiopia from 2023 to 2030. We included Haemophilus influenzae type B (Hib) vaccination, pneumococcal conjugate vaccine (PCV), oral antibiotics, pulse oximetry, and oxygen as pneumonia interventions in our analysis. Outcomes of interest were the number of pneumonia deaths averted, the proportion of deaths averted by intervention, and changes in the under-five mortality rate. Findings: We found that 19 775 lives of children under-five could be saved in Bangladesh, 76 470 in Chad, and 97 343 in Ethiopia by scaling intervention coverages to ≥90% by 2030. Our estimated reductions in pneumonia deaths among children under five range from 44.61% to 57.91% in the respective countries. Increased coverage of oral antibiotics, pulse oximetry, and oxygen show similar effects in all three countries, averting between 18.80% and 23.65% of expected pneumonia deaths. Scaling-up PCV has a prominent effect, especially in Chad, where it could avert 14.04% of expected pneumonia deaths. Under-five mortality could be reduced by 1.42 per 1000 live births in Bangladesh, 22.52 per 1000 live births in Chad, and 5.48 per 1000 live births in Ethiopia. Conclusions: This analysis shows the high impact of upscaling pneumonia interventions. The lack of data regarding coverage indicators is a barrier for further research, policy, and implementation, all requiring increased attention.

Pregnancy intervals after stillbirth, neonatal death and spontaneous abortion and the risk of an adverse outcome in the next pregnancy in rural Bangladesh.

BACKGROUND: Studies have revealed associations between preceding short and long birth-to-birth or birth-to-pregnancy intervals and poor pregnancy outcomes. Most of these studies, however, have examined the effect of intervals that began with live births. Using data from Bangladesh, we examined the effect of inter-outcome intervals (IOI) starting with a non-live birth or neonatal death, on outcomes in the next pregnancy. Pregnancy spacing behaviors in rural northeast Bangladesh have changed little since 2004. METHODS: We analyzed pregnancy histories for married women aged 15-49 years who had outcomes between 2000 and 2006 in Sylhet, Bangladesh. We examined the effects of the preceding outcome and the IOI length on the risk of stillbirth, neonatal death and spontaneous abortion using multinomial logistic regression models. RESULTS: Data included 64,897 pregnancy outcomes from 33,495 mothers. Inter-outcome intervals of 27-50 months and live births were baseline comparators. Stillbirths followed by IOI's <=6 months, 7-14 months or overall <=14 months had increased risks for spontaneous abortion with adjusted relative risk ratios (aRRR) and 95% confidence intervals = 29.6 (8.09, 108.26), 1.84 (0.84, 4.02) and 2.53 (1.19, 5.36), respectively. Stillbirths followed by IOIs 7-14 months had aRRR 2.00 (1.39, 2.88) for stillbirths. Neonatal deaths followed by IOIs <=6 months had aRRR 28.2 (8.59, 92.63) for spontaneous abortion. Neonatal deaths followed by IOIs 7-14 and 15-26 months had aRRRs 3.08 (1.82, 5.22) and 2.32 (1.38, 3.91), respectively, for stillbirths; and aRRRs 2.81 (2.06, 3.84) and 1.70 (1.24, 3.84), respectively, for neonatal deaths. Spontaneous abortions followed by IOIs <=6 months and 7-14 months had, respectively, aRRRs 23.21 (10.34, 52.13) and 1.80 (0.98, 3.33) for spontaneous abortion. CONCLUSION: In rural northeast Bangladesh, short inter-outcome intervals after stillbirth, neonatal death and spontaneous abortion were associated with a high risk of a similar outcome in the next pregnancy. These findings are aligned with other studies from Bangladesh. Two studies from similar settings have found benefits of waiting six months before conceiving again, suggesting that incorporating this advice into programs should be considered. Further research is warranted to confirm these findings.

A Controlled Before-and-After Perspective on the Improving Maternal, Neonatal, and Child Survival Program in Rural Bangladesh: An Impact Analysis.

OBJECTIVES: We evaluated the impact of the Improving Maternal, Neonatal, and Child Survival (IMNCS) project, which is being implemented by BRAC in rural communities in Bangladesh. METHODS: Four districts received program intervention i.e. trained community health workers to deliver essential maternal, neonatal, and child healthcare and nutrition services while two districts were treated as comparison group. A quasi-experimental study design (compared before-and-after) was undertaken. Baseline survey was conducted in 2008 among 7200 women followed by end line in 2012 among 4800 women with similar characteristics in the same villages. We evaluated maternal antenatal and post natal checkup, birth plans and delivery, complication and referred cases during antenatal checkup and post natal period, and child health indicators such as birth asphyxia, neonatal sepsis, and its management by the medically trained provider. FINDINGS: Increased number (four or more) antenatal visits, skill-birth attended delivery and postnatal visits (three or more) in the intervention group preceding four-year intervention period were observed compare to their counterpart. We noted negative difference-in-difference estimator (-5.0%, P = 0.159) regarding to the all major birth plans i.e. delivery place, birth attendant, and saved money in the comparison areas. Significant reduction of ante-partum and intra-partum complications occurred in the intervention group, contrary complications of such event increased in the comparison areas (-6.3%, P<0.05 and -20.5%, P<0.001 respectively). Referral case to the health centers due to these complications boosted significantly in intervention group than comparison group (2.3%, P<0.01 and 6.6%, P<0.001 respectively). Mother's knowledge of breastfeeding initiation and the practice of initiating breastfeeding within an hour of birth amplified significantly (14.6%, P<0.001 and 8.3%, P<0.001 respectively). We did not find any significant difference regards to the management of low birth weight by the medically trained health care provider and complete vaccination between the intervention and comparison arm. CONCLUSION: Medically trained health care provider assisted community based public health intervention could increase number of antenatal and postnatal visit, thereby could decrease pregnancy associated complications. These interventions may be considered for further up scaling when resources are limited.

Assessing Community Based Improved Maternal Neonatal Child Survival (IMNCS) Program in Rural Bangladesh.

OBJECTIVES: A community based approach before, during and after child birth has been proven effective address the burden of maternal, neonatal and child morbidity and mortality in the low and middle income countries. We aimed to examine the overall change in maternal and newborn health outcomes due the "Improved Maternal Newborn and Child Survival" (IMNCS) project, which was implemented by BRAC in rural communities of Bangladesh. METHODS: The intervention was implemented in four districts for duration of 5-years, while two districts served as comparison areas. The intervention was delivered by community health workers who were trained on essential maternal, neonatal and child health care services. A baseline survey was conducted in 2008 among 7, 200 women with pregnancy outcome in last year or having a currently alive child of 12-59 months. A follow-up survey was administered in 2012-13 among 4, 800 women of similar characteristics in the same villages. FINDINGS: We observed significant improvements in maternal and essential newborn care in intervention areas over time, especially in health care seeking behaviors. The proportion of births taking place at home declined in the intervention districts from 84.3% at baseline to 71.2% at end line (P<0.001). Proportion of deliveries with skilled attendant was higher in intervention districts (28%) compared to comparison districts (27.4%). The number of deliveries was almost doubled at public sector facility comparing with baseline (P<0.001). Significant improvement was also observed in healthy cord care practice, delayed bathing of the new-born and reduction of infant mortality in intervention districts compared to that of comparison districts. CONCLUSIONS: This study demonstrates that community-based efforts offer encouraging evidence and value for combining maternal, neonatal and child health care package. This approach might be considered at larger scale in similar settings with limited resources.

Economic evaluation of neonatal care packages in a cluster-randomized controlled trial in Sylhet, Bangladesh.

OBJECTIVE: To evaluate and compare the cost-effectiveness of two strategies for neonatal care in Sylhet division, Bangladesh. METHODS: In a cluster-randomized controlled trial, two strategies for neonatal care--known as home care and community care--were compared with existing services. For each study arm, economic costs were estimated from a societal perspective, inclusive of programme costs, provider costs and household out-of-pocket payments on care-seeking. Neonatal mortality in each study arm was determined through household surveys. The incremental cost-effectiveness of each strategy--compared with that of the pre-existing levels of maternal and neonatal care--was then estimated. The levels of uncertainty in our estimates were quantified through probabilistic sensitivity analysis. FINDINGS: The incremental programme costs of implementing the home-care package were 2939 (95% confidence interval, CI: 1833-7616) United States dollars (US$) per neonatal death averted and US$ 103.49 (95% CI: 64.72-265.93) per disability-adjusted life year (DALY) averted. The corresponding total societal costs were US$ 2971 (95% CI: 1844-7628) and US$ 104.62 (95% CI: 65.15-266.60), respectively. The home-care package was cost-effective--with 95% certainty--if healthy life years were valued above US$ 214 per DALY averted. In contrast, implementation of the community-care strategy led to no reduction in neonatal mortality and did not appear to be cost-effective. CONCLUSION: The home-care package represents a highly cost-effective intervention strategy that should be considered for replication and scale-up in Bangladesh and similar settings elsewhere.

Chlorhexidine cleansing of the umbilical cord and separation time: a cluster-randomized trial.

OBJECTIVE: Cord cleansing with chlorhexidine reduces neonatal mortality. We aimed to quantify the impact of this intervention on cord separation time and the implications of such an increase on maternal and other caretaker's acceptance of chlorhexidine in future scaled up programs. METHODS: Between June 2007 and September 2009, 29,760 newborns were randomly assigned within communities in Bangladesh to receive 1 of 3 cord regimens: dry and clean cord care (comparison), single-cleansing, or multiple-cleansing with 4.0% chlorhexidine. Workers recorded separation status during home visits. Mothers of 380 infants in randomly selected clusters reported age at separation and satisfaction with cord regimen. RESULTS: Compared with dry and clean care (mean 4.78 days), separation time was longer in the single (mean 6.90 days, difference = 2.10; 95% confidence interval: 1.85-2.35) and multiple (mean 7.49 days, difference = 2.69; 95% confidence interval: 2.44-2.95) cleansing groups. Increased separation time was not associated with omphalitis. Mothers in these groups more frequently reported "longer than usual" separation times and dissatisfaction with the separation time (11.1% and 17.6%, respectively) versus the comparison group (2.5%). Overall satisfaction with the received cord care regimen was high (96.2%). CONCLUSIONS: Topical chlorhexidine increased cord separation time by ∼50%. Caretakers are likely to detect this increase and might express dissatisfaction but still accept the intervention overall. When scaling up chlorhexidine cord cleansing, inclusion of appropriate messaging on expectation and nonrisks of increased cord separation time, in addition to the benefits of reduced infection and improved survival, might improve compliance.

The effect of umbilical cord cleansing with chlorhexidine on omphalitis and neonatal mortality in community settings in developing countries: a meta-analysis.

BACKGROUND: There is an increased risk of serious neonatal infection arising through exposure of the umbilical cord to invasive pathogen in home and facility births where hygienic practices are difficult to achieve. The World Health Organization currently recommends 'dry cord care' because of insufficient data in favor of or against topical application of an antiseptic. The primary objective of this meta-analysis is to evaluate the effects of application of chlorhexidine (CHX) to the umbilical cord to children born in low income countries on cord infection (omphalitis) and neonatal mortality. Standardized guidelines of Child Health Epidemiology Reference Group (CHERG) were followed to generate estimates of effectiveness of topical chlorhexidine application to umbilical cord for prevention of sepsis specific mortality, for inclusion in the Lives Saved Tool (LiST). METHODS: Systematic review and meta-analysis. Data sources included Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, PubMed, CINHAL and WHO international clinical trials registry. Only randomized trials were included. Studies of children in hospital settings were excluded. The comparison group received no application to the umbilical cord (dry cord care), no intervention, or a non-CHX intervention. Primary outcomes were omphalitis and all-cause neonatal mortality. RESULTS: There were three cluster-randomised community trials (total participants 54,624) conducted in Nepal, Bangladesh and Pakistan that assessed impact of CHX application to the newborn umbilical cord for prevention of cord infection and mortality. Application of any CHX to the umbilical cord of the newborn led to a 23% reduction in all-cause neonatal mortality in the intervention group compared to control [RR 0.77, 95 % CI 0.63, 0.94; random effects model, I2=50 %]. The reduction in omphalitis ranged from 27 % to 56 % compared to control group depending on severity of infection. Based on CHERG rules, effect size for all-cause mortality was used for inclusion to LiST model as a proxy for sepsis specific mortality. CONCLUSIONS: Application of CHX to newborn umbilical cord can significantly reduce incidence of umbilical cord infection and all-cause mortality among home births in community settings. This inexpensive and simple intervention can save a significant number of newborn lives in developing countries.

Operations research to add postpartum family planning to maternal and neonatal health to improve birth spacing in Sylhet District, Bangladesh.

BACKGROUND: Short birth intervals are associated with increased risk of adverse maternal and neonatal health (MNH) outcomes. Improving postpartum contraceptive use is an important programmatic strategy to improve the health and well-being of women, newborns, and children. This article documents the intervention package and evaluation design of a study conducted in a rural district of Bangladesh to evaluate the effects of an integrated, community-based MNH and postpartum family planning program on contraceptive use and birth-interval lengths. INTERVENTION: The study integrated family planning counseling within 5 community health worker (CHW)-household visits to pregnant and postpartum women, while a community mobilizer (CM) led community meetings on the importance of postpartum family planning and pregnancy spacing for maternal and child health. The CM and the CHWs emphasized 3 messages: (1) Use of the Lactational Amenorrhea Method (LAM) during the first 6 months postpartum and transition to another modern contraceptive method; (2) Exclusive, rather than fully or nearly fully, breastfeeding to support LAM effectiveness and good infant breastfeeding practices; (3) Use of a modern contraceptive method after a live birth for at least 24 months before attempting another pregnancy (a birth-to-birth interval of about 3 years) to support improved infant health and nutrition. CHWs provided only family planning counseling in the original study design, but we later added community-based distribution of methods, and referrals for clinical methods, to meet women's demand. METHODS: Using a quasi-experimental design, and relying primarily on pre/post-household surveys, we selected pregnant women from 4 unions to receive the intervention (n = 2,280) and pregnant women from 4 other unions (n = 2,290) to serve as the comparison group. Enrollment occurred between 2007 and 2009, and data collection ended in January 2013. PRELIMINARY RESULTS: Formative research showed that women and their family members generally did not perceive birth spacing as a priority, and most recently delivered women were not using contraception. At baseline, women in the intervention and comparison groups were similar in terms of age, husband's education, religion, and parity. CHWs visited over 90% of women in both intervention and comparison groups during pregnancy and the first 3 months postpartum. DISCUSSION: This article provides helpful intervention-design details for program managers intending to add postpartum family planning services to community-based MNH programs. Outcomes of the intervention will be reported in a future paper. Preliminary findings indicate that the package of 5 CHW visits was feasible and did not compromise worker performance. Adding doorstep delivery of contraceptives to the intervention package may enhance impact.

Impact of 4.0% chlorhexidine cord cleansing on the bacteriologic profile of the newborn umbilical stump in rural Sylhet District, Bangladesh: a community-based, cluster-randomized trial.

BACKGROUND: Randomized trials from South Asia indicate umbilical cord chlorhexidine cleansing reduces mortality and omphalitis. No community-based data are available on bacteriological profile of the cord, early neonatal colonization dynamics, or impact of cord cleansing on colonizing organisms. Such data could clarify the design of scaled chlorhexidine interventions. METHODS: Umbilical swabs were collected at home (days 1, 3, 6) after birth from infants participating in a trial of 3 cord-care regimens (no chlorhexidine, single cleansing, multiple cleansing) in Sylhet, Bangladesh. Overall and organism-specific positivity rates were estimated by cord-care regimen and by day of collection. RESULTS: Between September 2008 and October 2009, 1923 infants contributed 5234 umbilical swabs. Positivity rate was high (4057 of 5234, 77.5%) and varied substantially across groups. Immediate (day 1) reductions in cord colonization were observed in single- (prevalence rate ratio = 0.75, 95% confidence interval: 0.70-0.81) and multiple- (prevalence rate ratio = 0.71, 95% confidence interval: 0.66-0.77) cleansing groups. Reductions persisted and increased in magnitude through day 6 only if babies received multiple applications. On days 1, 3, and 6, respectively, multiple cleansing consistently reduced invasive organisms such as Escherichia coli (49%, 64%, and 42% lower), Klebsiella pneumoniae (46%, 53%, and 33% lower), and Staphylococcus aureus (34%, 84%, and 85% lower). CONCLUSIONS: Cord cleansing with 4.0% chlorhexidine immediately after birth reduces overall and organism-specific colonization of the stump. Reductions are greater and sustained longer with daily cleansing through the first week of life, suggesting that programs promoting chlorhexidine cleansing should favor multiple over single applications.

The effect of cord cleansing with chlorhexidine on neonatal mortality in rural Bangladesh: a community-based, cluster-randomised trial.

BACKGROUND: Up to half of neonatal deaths in high mortality settings are due to infections, many of which can originate through the freshly cut umbilical cord stump. We aimed to assess the effectiveness of two cord-cleansing regimens with the promotion of dry cord care in the prevention of neonatal mortality. DESIGN: We did a community-based, parallel cluster-randomised trial in Sylhet, Bangladesh. We divided the study area into 133 clusters, which were randomly assigned to one of the two chlorhexidine cleansing regimens (single cleansing as soon as possible after birth; daily cleansing for 7 days after birth) or promotion of dry cord care. Randomisation was done by use of a computer-generated sequence, stratified by cluster-specific participation in a previous trial. All livebirths were eligible; those visited within 7 days by a local female village health worker trained to deliver the cord care intervention were enrolled. We did not mask study workers and participants to the study interventions. Our primary outcome was neonatal mortality (within 28 days of birth) per 1000 livebirths, which we analysed on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT00434408. RESULTS: Between June, 2007, and September, 2009, we enrolled 29 760 newborn babies (10 329, 9423, and 10 008 in the multiple-cleansing, single-cleansing, and dry cord care groups, respectively). Neonatal mortality was lower in the single-cleansing group (22·5 per 1000 livebirths) than it was in the dry cord care group (28·3 per 1000 livebirths; relative risk [RR] 0·80 [95% CI] 0·65-0·98). Neonatal mortality in the multiple-cleansing group (26·6 per 1000 livebirths) was not statistically significantly lower than it was in the dry cord care group (RR 0·94 [0·78-1·14]). Compared with the dry cord care group, we recorded a statistically significant reduction in the occurrence of severe cord infection (redness with pus) in the multiple-cleansing group (risk per 1000 livebirths=4·2 vs risk per 1000 livebirths=1·2; RR 0·35 [0·15-0·81]) but not in the single-cleansing group (risk per 1000 livebirths=3·3; RR 0·77 [0·40-1·48]). INTERPRETATION: Chlorhexidine cleansing of a neonate's umbilical cord can save lives, but further studies are needed to establish the best frequency with which to deliver the intervention. FUNDING: United States Agency for International Development and Save the Children's Saving Newborn Lives program, through a grant from the Bill & Melinda Gates Foundation.

Vulnerability of newborns to environmental factors: findings from community based surveillance data in Bangladesh.

Infection is the major cause of neonatal deaths. Home born newborns in rural Bangladeshi communities are exposed to environmental factors increasing their vulnerability to a number of disease agents that may compromise their health. The current analysis was conducted to assess the association of very severe disease (VSD) in newborns in rural communities with temperature, rainfall, and humidity. A total of 12,836 newborns from rural Sylhet and Mirzapur communities were assessed by trained community health workers using a sign based algorithm. Records of temperature, humidity, and rainfall were collected from the nearest meteorological stations. Associations between VSD and environmental factors were estimated. Incidence of VSD was found to be associated with higher temperatures (odds ratios: 1.14, 95% CI: 1.08 to 1.21 in Sylhet and 1.06, 95% CI: 1.04 to 1.07 in Mirzapur) and heat humidity index (odds ratios: 1.06, 95% CI: 1.04 to 1.08 in Sylhet and, 1.03, 95% CI: 1.01 to 1.04 in Mirzapur). Four months (June-September) in Sylhet, and six months in Mirzapur (April-September) had higher odds ratios of incidence of VSD as compared to the remainder of the year (odds ratios: 1.72, 95% CI: 1.32 to 2.23 in Sylhet and, 1.62, 95% CI: 1.33 to 1.96 in Mirzapur). Prevention of VSD in neonates can be enhanced if these interactions are considered in health intervention strategies.

Factors affecting recruitment and retention of community health workers in a newborn care intervention in Bangladesh.

BACKGROUND: Well-trained and highly motivated community health workers (CHWs) are critical for delivery of many community-based newborn care interventions. High rates of CHW attrition undermine programme effectiveness and potential for implementation at scale. We investigated reasons for high rates of CHW attrition in Sylhet District in north-eastern Bangladesh. METHODS: Sixty-nine semi-structured questionnaires were administered to CHWs currently working with the project, as well as to those who had left. Process documentation was also carried out to identify project strengths and weaknesses, which included in-depth interviews, focus group discussions, review of project records (i.e. recruitment and resignation), and informal discussion with key project personnel. RESULTS: Motivation for becoming a CHW appeared to stem primarily from the desire for self-development, to improve community health, and for utilization of free time. The most common factors cited for continuing as a CHW were financial incentive, feeling needed by the community, and the value of the CHW position in securing future career advancement. Factors contributing to attrition included heavy workload, night visits, working outside of one's home area, familial opposition and dissatisfaction with pay. CONCLUSIONS: The framework presented illustrates the decision making process women go through when deciding to become, or continue as, a CHW. Factors such as job satisfaction, community valuation of CHW work, and fulfilment of pre-hire expectations all need to be addressed systematically by programs to reduce rates of CHW attrition.

Community-based health workers achieve high coverage in neonatal intervention trials: a case study from Sylhet, Bangladesh.

A large proportion of four million neonatal deaths occur each year during the first 24 hours of life. Research is particularly needed to determine the efficacy of interventions during the first 24 hours. Large cadres of community-based workers are required in newborn-care research both to deliver these interventions in a standardized manner in the home and to measure the outcomes of the study. In a large-scale community-based efficacy trial of chlorhexidine for cleansing the cord in north-eastern rural Bangladesh, a two-tiered system of community-based workers was established to deliver a package of essential maternal and newborn-care interventions and one of three umbilical cord-care regimens. At any given time, the trial employed approximately 133 community health workers--each responsible for 4-5 village health workers and a population of approximately 4,000. Over the entire trial period, 29,760 neonates were enrolled, and 87% of them received the intervention (their assigned cord-care regimen) within 24 hours of birth. Approaches to recruitment, training, and supervision in the study are described. Key lessons included the importance of supportive processes for community-based workers, including a strong training and field supervisory system, community acceptance of the study, consideration of the setting, study objectives, and human resources available.

Impact of 4.0% chlorhexidine cleansing of the umbilical cord on mortality and omphalitis among newborns of Sylhet, Bangladesh: design of a community-based cluster randomized trial.

BACKGROUND: The World Health Organization recommends dry cord care for newborns but this recommendation may not be optimal in low resource settings where most births take place in an unclean environment and infections account for up to half of neonatal deaths. A previous trial in Nepal indicated that umbilical cord cleansing with 4.0% chlorhexidine could substantially reduce mortality and omphalitis risk, but policy changes await additional community-based data. METHODS: The Projahnmo Chlorhexidine study was a three-year, cluster-randomized, community-based trial to assess the impact of three cord care regimens on neonatal mortality and omphalitis. Women were recruited mid-pregnancy, received a basic package of maternal and neonatal health promotion messages, and were followed to pregnancy outcome. Newborns were visited at home by local village-based workers whose areas were randomized to either 1) single- or 2) 7-day cord cleansing with 4.0% chlorhexidine, or 3) promotion of dry cord care as recommended by WHO. All mothers received basic messages regarding hand-washing, clean cord cutting, and avoidance of harmful home-base applications to the cord. Death within 28 days and omphalitis were the primary outcomes; these were monitored directly through home visits by community health workers on days 1, 3, 6, 9, 15, and 28 after birth. DISCUSSION: Due to report in early 2010, the Projahnmo Chlorhexidine Study examines the impact of multiple or single chlorhexidine cleansing of the cord on neonatal mortality and omphalitis among newborns of rural Sylhet District, Bangladesh. The results of this trial will be interpreted in conjunction with a similarly designed trial previously conducted in Nepal, and will have implications for policy guidelines for optimal cord care of newborns in low resource settings in Asia. TRIAL REGISTRATION: ClinicalTrials.gov (NCT00434408).

Effect of community-based newborn-care intervention package implemented through two service-delivery strategies in Sylhet district, Bangladesh: a cluster-randomised controlled trial.

BACKGROUND: Neonatal mortality accounts for a high proportion of deaths in children under the age of 5 years in Bangladesh. Therefore the project for advancing the health of newborns and mothers (Projahnmo) implemented a community-based intervention package through government and non-government organisation infrastructures to reduce neonatal mortality. METHODS: In Sylhet district, 24 clusters (with a population of about 20 000 each) were randomly assigned in equal numbers to one of two intervention arms or to the comparison arm. Because of the study design, masking was not feasible. All married women of reproductive age (15-49 years) were eligible to participate. In the home-care arm, female community health workers (one per 4000 population) identified pregnant women, made two antenatal home visits to promote birth and newborn-care preparedness, made postnatal home visits to assess newborns on the first, third, and seventh days of birth, and referred or treated sick neonates. In the community-care arm, birth and newborn-care preparedness and careseeking from qualified providers were promoted solely through group sessions held by female and male community mobilisers. The primary outcome was reduction in neonatal mortality. Analysis was by intention to treat. The study is registered with ClinicalTrials.gov, number 00198705. FINDINGS: The number of clusters per arm was eight. The number of participants was 36059, 40159, and 37598 in the home-care, community-care, and comparison arms, respectively, with 14 769, 16 325, and 15 350 livebirths, respectively. In the last 6 months of the 30-month intervention, neonatal mortality rates were 29.2 per 1000, 45.2 per 1000, and 43.5 per 1000 in the home-care, community-care, and comparison arms, respectively. Neonatal mortality was reduced in the home-care arm by 34% (adjusted relative risk 0.66; 95% CI 0.47-0.93) during the last 6 months versus that in the comparison arm. No mortality reduction was noted in the community-care arm (0.95; 0.69-1.31). INTERPRETATION: A home-care strategy to promote an integrated package of preventive and curative newborn care is effective in reducing neonatal mortality in communities with a weak health system, low health-care use, and high neonatal mortality.