Gary L. Darmstadt

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.

Effect of community-based behaviour change management on neonatal mortality in Shivgarh, Uttar Pradesh, India: a cluster-randomised controlled trial

BACKGROUND In rural India, most births take place in the home, where high-risk care practices are common. We developed an intervention of behaviour change management, with a focus on prevention of hypothermia, aimed at modifying practices and reducing neonatal mortality. METHODS We did a cluster-randomised controlled efficacy trial in Shivgarh, a rural area in Uttar Pradesh. 39 village administrative units (population 104,123) were allocated to one of three groups: a control group, which received the usual services of governmental and non-governmental organisations in the area; an intervention group, which received a preventive package of interventions for essential newborn care (birth preparedness, clean delivery and cord care, thermal care [including skin-to-skin care], breastfeeding promotion, and danger sign recognition); or another intervention group, which received the package of essential newborn care plus use of a liquid crystal hypothermia indicator (ThermoSpot). In the intervention clusters, community health workers delivered the packages via collective meetings and two antenatal and two postnatal household visitations. Outcome measures included changes in newborn-care practices and neonatal mortality rate compared with the control group. Analysis was by intention to treat. This study is registered as International Standard Randomised Control Trial, number NCT00198653. FINDINGS Improvements in birth preparedness, hygienic delivery, thermal care (including skin-to-skin care), umbilical cord care, skin care, and breastfeeding were seen in intervention arms. There was little change in care-seeking. Compared with controls, neonatal mortality rate was reduced by 54% in the essential newborn-care intervention (rate ratio 0.46 [95% CI 0.35-0.60], p<0.0001) and by 52% in the essential newborn care plus ThermoSpot arm (0.48 [95% CI 0.35-0.66], p<0.0001). INTERPRETATION A socioculturally contextualised, community-based intervention, targeted at high-risk newborn-care practices, can lead to substantial behavioural modification and reduction in neonatal mortality. This approach can be applied to behaviour change along the continuum of care, harmonise vertical interventions, and build community capacity for sustained development. FUNDING USAID and Save the Children-US through a grant from the Bill & Melinda Gates Foundation.

Topical applications of chlorhexidine to the umbilical cord for prevention of omphalitis and neonatal mortality in southern Nepal: a community-based, cluster-randomised trial

BACKGROUND Omphalitis contributes to neonatal morbidity and mortality in developing countries. Umbilical cord cleansing with antiseptics might reduce infection and mortality risk, but has not been rigorously investigated. METHODS In our community-based, cluster-randomised trial, 413 communities in Sarlahi, Nepal, were randomly assigned to one of three cord-care regimens. 4934 infants were assigned to 4.0% chlorhexidine, 5107 to cleansing with soap and water, and 5082 to dry cord care. In intervention clusters, the newborn cord was cleansed in the home on days 1-4, 6, 8, and 10. In all clusters, the cord was examined for signs of infection (pus, redness, or swelling) on these visits and in follow-up visits on days 12, 14, 21, and 28. Incidence of omphalitis was defined under three sign-based algorithms, with increasing severity. Infant vital status was recorded for 28 completed days. The primary outcomes were incidence of neonatal omphalitis and neonatal mortality. Analysis was by intention-to-treat. This trial is registered with , number NCT00109616. FINDINGS Frequency of omphalitis by all three definitions was reduced significantly in the chlorhexidine group. Severe omphalitis in chlorhexidine clusters was reduced by 75% (incidence rate ratio 0.25, 95% CI 0.12-0.53; 13 infections/4839 neonatal periods) compared with dry cord-care clusters (52/4930). Neonatal mortality was 24% lower in the chlorhexidine group (relative risk 0.76 [95% CI 0.55-1.04]) than in the dry cord care group. In infants enrolled within the first 24 h, mortality was significantly reduced by 34% in the chlorhexidine group (0.66 [0.46-0.95]). Soap and water did not reduce infection or mortality risk. INTERPRETATION Recommendations for dry cord care should be reconsidered on the basis of these findings that early antisepsis with chlorhexidine of the umbilical cord reduces local cord infections and overall neonatal mortality.

Impact of topical oils on the skin barrier: possible implications for neonatal health in developing countries

Topical therapy to enhance skin barrier function may be a simple, low‐cost, effective strategy to improve outcome of preterm infants with a developmentally compromised epidermal barrier, as lipid constituents of topical products may act as a mechanical barrier and augment synthesis of barrier lipids. Natural oils are applied topically as part of a traditional oil massage to neonates in many developing countries. We sought to identify inexpensive, safe, vegetable oils available in developing countries that improved epidermal barrier function. The impact of oils on mouse epidermal barrier function (rate of transepidermal water loss over time following acute barrier disruption by tape‐stripping) and ultrastructure was determined. A single application of sunflower seed oil significantly accelerated skin barrier recovery within 1 h; the effect was sustained 5 h after application. In contrast, the other vegetable oils tested (mustard, olive and soybean oils) all significantly delayed recovery of barrier function compared with control‐ or Aquaphor‐treated skin. Twice‐daily applications of mustard oil for 7 d resulted in sustained delay of barrier recovery. Moreover, adverse ultrastructural changes were seen under transmission electron microscopy in keratin intermediate filament, mitochondrial, nuclear, and nuclear envelope structure following a single application of mustard oil.

Childhood Disability in Low- and Middle-Income Countries: Overview of Screening, Prevention, Services, Legislation, and Epidemiology

BACKGROUND. Childhood disability affects millions of children around the world, most of whom are in low- and middle-income countries. Despite the large burden on child development, family life, and economics, research in the area of childhood disability is woefully inadequate, especially from low- and middle-income countries. OBJECTIVE. The objective of this review was to generate information about current knowledge on childhood disability in low- and middle-income countries and identify gaps to guide future research. METHODS. Electronic databases (PubMed, Embase, PsycInfo) were searched by using specific search terms related to childhood disability in developing countries. The Cochrane Library was also searched to identify any similar reviews. Whole texts of articles that met study criteria were scrutinized for information regarding research method, screening tools, epidemiology, disability-related services, legislation, and prevention and promotion activities. Quantitative and qualitative information was collated, and frequency distributions of research parameters were generated. RESULTS. Eighty articles were included in the review (41 from low-income countries). Almost 60% of the studies were cross-sectional; case-control, cohort, and randomized, controlled trials accounted for only 15% of the studies. Of the 80 studies, 66 focused on epidemiologic research. Hearing (26%) and intellectual (26%) disabilities were the commonly studied conditions. The Ten Questionnaire was the most commonly used screening tool. Information on specific interventions, service utilization, and legislation was lacking, and study quality generally was inadequate. Data on outcomes of morbidities, including delivery complications and neonatal and early childhood illness, is particularly lacking. CONCLUSIONS. With this review we identified potential gaps in knowledge, especially in the areas of intervention, service utilization, and legislation. Even epidemiologic research was of inadequate quality, and research was lacking on conditions other than hearing and intellectual disabilities. Future researchers should not only address these gaps in current knowledge but also take steps to translate their research into public health policy changes that would affect the lives of children with disabilities in low- and middle-income countries.

60 million non-facility births: Who can deliver in community settings to reduce intrapartum-related deaths?

For the worlds 60 million non‐facility births, addressing who is currently attending these births and what effect they have on birth outcomes is a key starting point toward improving care during childbirth.

Preventing Preterm Birth and Neonatal Mortality: Exploring the Epidemiology, Causes, and Interventions

Globally, each year, an estimated 13 million infants are born before 37 completed weeks of gestation. Complications from these preterm births are the leading cause of neonatal mortality. Preterm birth is directly responsible for an estimated one million neonatal deaths annually and is also an important contributor to child and adult morbidities. Low- and middle-income countries are disproportionately affected by preterm birth and carry a greater burden of disease attributed to preterm birth. Causes of preterm birth are multifactorial, vary by gestational age, and likely vary by geographic and ethnic contexts. Although many interventions have been evaluated, few have moderate-to high-quality evidence for decreasing preterm birth: smoking cessation and progesterone treatment in women with a high risk of preterm birth in low- and middle-income countries and cervical cerclage for those in high-income countries. Antepartum and postnatal interventions (eg, antepartum maternal steroid administration, or kangaroo mother care) to improve preterm neonatal survival after birth have been demonstrated to be effective but have not been widely implemented. Further research efforts are urgently needed to better understand context-specific pathways leading to preterm birth; to develop appropriate, efficacious prevention strategies and interventions to improve survival of neonates born prematurely; and to scale-up known efficacious interventions to improve the health of the preterm neonate.

Neonatal resuscitation and immediate newborn assessment and stimulation for the prevention of neonatal deaths: a systematic review, meta-analysis and Delphi estimation of mortality effect

BackgroundOf 136 million babies born annually, around 10 million require assistance to breathe. Each year 814,000 neonatal deaths result from intrapartum-related events in term babies (previously “birth asphyxia”) and 1.03 million from complications of prematurity. No systematic assessment of mortality reduction from tactile stimulation or resuscitation has been published.ObjectiveTo estimate the mortality effect of immediate newborn assessment and stimulation, and basic resuscitation on neonatal deaths due to term intrapartum-related events or preterm birth, for facility and home births.MethodsWe conducted systematic reviews for studies reporting relevant mortality or morbidity outcomes. Evidence was assessed using GRADE criteria adapted to provide a systematic approach to mortality effect estimates for the Lives Saved Tool (LiST). Meta-analysis was performed if appropriate. For interventions with low quality evidence but strong recommendation for implementation, a Delphi panel was convened to estimate effect size.ResultsWe identified 24 studies of neonatal resuscitation reporting mortality outcomes (20 observational, 2 quasi-experimental, 2 cluster randomized controlled trials), but none of immediate newborn assessment and stimulation alone. A meta-analysis of three facility-based studies examined the effect of resuscitation training on intrapartum-related neonatal deaths (RR= 0.70, 95%CI 0.59-0.84); this estimate was used for the effect of facility-based basic neonatal resuscitation (additional to stimulation). The evidence for preterm mortality effect was low quality and thus expert opinion was sought. In community-based studies, resuscitation training was part of packages with multiple concurrent interventions, and/or studies did not distinguish term intrapartum-related from preterm deaths, hence no meta-analysis was conducted. Our Delphi panel of 18 experts estimated that immediate newborn assessment and stimulation would reduce both intrapartum-related and preterm deaths by 10%, facility-based resuscitation would prevent a further 10% of preterm deaths, and community-based resuscitation would prevent further 20% of intrapartum-related and 5% of preterm deaths.ConclusionNeonatal resuscitation training in facilities reduces term intrapartum-related deaths by 30%. Yet, coverage of this intervention remains low in countries where most neonatal deaths occur and is a missed opportunity to save lives. Expert opinion supports smaller effects of neonatal resuscitation on preterm mortality in facilities and of basic resuscitation and newborn assessment and stimulation at community level. Further evaluation is required for impact, cost and implementation strategies in various contexts.FundingThis work was supported by the Bill & Melinda Gates Foundation through a grant to the US Fund for UNICEF, and to the Saving Newborn Lives program of Save the Children, through Save the Children US.

Local understandings of vulnerability and protection during the neonatal period in Sylhet district Bangladesh: a qualitative study.

BACKGROUND Understanding of local knowledge and practices relating to the newborn period, as locally defined, is needed in the development of interventions to reduce neonatal mortality. We describe the organisation of the neonatal period in Sylhet District, Bangladesh, the perceived threats to the well-being of neonates, and the ways in which families seek to protect them. METHODS We did 39 in-depth, unstructured, qualitative interviews with mothers, fathers, and grandmothers of neonates, and traditional birth attendants. Data on neonatal knowledge and practices were also obtained from a household survey of 6050 women who had recently given birth. FINDINGS Interviewees defined the neonatal period as the first 40 days of life (chollish din). Confinement of the mother and baby is most strongly observed before the noai ceremony on day 7 or 9, and involves restriction of movement outside the home, sleeping where the birth took place rather than in the mothers bedroom, and sleeping on a mat on the floor. Newborns are seen as vulnerable to cold air, cold food or drinks (either directly or indirectly through the mother), and to malevolent spirits or evil eye. Bathing, skin care, confinement, and dietary practices all aim to reduce exposure to cold, but some of these practices might increase the risk of hypothermia. INTERPRETATION Although fatalism and cultural acceptance of high mortality have been cited as reasons for high levels of neonatal mortality, Sylheti families seek to protect newborns in several ways. These actions reflect a set of assumptions about the newborn period that differ from those of neonatal health specialists, and have implications for the design of interventions for neonatal care.

Rates, timing and causes of neonatal deaths in rural India: implications for neonatal health programmes.

OBJECTIVE To assess the rates, timing and causes of neonatal deaths and the burden of stillbirths in rural Uttar Pradesh, India. We discuss the implications of our findings for neonatal interventions. METHODS We used verbal autopsy interviews to investigate 1048 neonatal deaths and stillbirths. FINDINGS There were 430 stillbirths reported, comprising 41% of all deaths in the sample. Of the 618 live births, 32% deaths were on the day of birth, 50% occurred during the first 3 days of life and 71% were during the first week. The primary causes of death on the first day of life (i.e. day 0) were birth asphyxia or injury (31%) and preterm birth (26%). During days 1-6, the most frequent causes of death were preterm birth (30%) and sepsis or pneumonia (25%). Half of all deaths caused by sepsis or pneumonia occurred during the first week of life. The proportion of deaths attributed to sepsis or pneumonia increased to 45% and 36% during days 7-13 and 14-27, respectively. CONCLUSION Stillbirths and deaths on the day of birth represent a large proportion of perinatal and neonatal deaths, highlighting an urgent need to improve coverage with skilled birth attendants and to ensure access to emergency obstetric care. Health interventions to improve essential neonatal care and care-seeking behavior are also needed, particularly for preterm neonates in the early postnatal period.