Focusing on early and universal child development is potentially the most promising strategy to break the vicious intergenerational cycle of poverty that is perpetrating an increasingly inequitable and unjust world order.  From 2004 to 2005, an intervention package for home-based essential newborn care was disseminated in rural Uttar Pradesh.  The package was delivered through two antenatal and two postnatal visits by community healthcare workers.  The intervention package can be broadly categorized into birth preparedness, hygienic delivery, and immediate newborn care, thermal care, breastfeeding, and care-seeking from trained providers.

The intervention package, though simple, was multi-faceted and could have affected neurodevelopmental outcomes through 4 main pathways: reduced incidence of newborn infections, improved nutrition and reduced risk of hypoglycemia, improved management of birth and care-seeking for newborn illnesses, and improved stimulation and a more nurturing environment. At present, the children who were in the trial are 7-9 years of age, and will be assessed to determine whether the original intervention had long-term impacts on their cognitive development.

• 3890 mothers and 3688 newborns were enrolled in the intervention.
• Neonatal mortality was reduced by 52-54% compared to the control group. [1]

Funders

Grand Challenges Canada

• Established rapport with the community at the study site and previous experience of study investigators in conducting high-quality community-based studies.
• Collaboration with multiple partners, including the World Health Organization and a technical advisory group of global experts.
• Empowerment of families to provide high-quality essential newborn care at home increased sustainability.

The Shivgarh intervention is already being scaled by the government of Uttar Pradesh under the aegis of the National Rural Health Mission, as part of an integrated ‘comprehensive child survival program’ in all 72 districts of the state (population 200 million) through frontline ASHA workers. As part of a recent grant by the Gates Foundation, the Shivgarh intervention will also be scaled up in a quarter of the state of UP through an alternative demand-side platform of self-help groups. Aspects of the intervention and delivery mechanism are also being adapted by programs for low-resource settings in Africa.

For the original intervention, data on pregnancies, births and deaths was collected through a demographic surveillance and community notification system. Information on knowledge, attitudes, practices, and constraints regarding maternal and newborn care was collected from 88% of all mothers. Anthropometric measurements recorded for about 60% of the enrolled babies at birth included birth weight, length, foot length, head circumference, and chest circumference. [1]

To assess the neurodevelopment impact, the following domains will be tested: Physical growth and body composition, Cognitive-language (including general intelligence, memory, and executive function), sensori-motor (including fine motor skills), Social-emotional-behavioral and Productivity (including educational attainment) using suitable assessment tools. In addition, in order to adjust for confounding factors and understand risk factors for neurodevelopmental impairment, the following will also be measured: home and community environment, Socio-economic status, food security and micronutrient deficiencies and Other disorders or illnesses.

The primary outcome of the trial was neonatal mortality rate. Secondary outcomes included changes in newborn and maternal care practices, maternal mortality ratio, etc. the trial enrolled 1600, 1149 and 1141 pregnant women respectively, and 1522, 1087 and 1079 newborns respectively in the three study arms. [1] Neonatal mortality was reduced by over 50% compared to the control group. [1] An important emergent effect of the intervention was an improvement in maternal health outcomes, including knowledge of danger signs, care practices, self-reported complications, and timely care-seeking from trained providers⁴ . Improvements in key practices in the intervention group include an increase in: identification of newborn attendant (22 vs. 4.4%), immediate wiping of whole infant body (93 vs. 18%), skin-to-skin care (85 vs 10%). [1] These are hypothesized to contribute towards improved neurodevelopment.

The Shivgarh intervention shifted the perception of newborn survival from a specialized illness-management paradigm to a universal behavior-management paradigm. The intervention itself is highly empowering for communities and aims at improving the efficacy of families to provide high-quality essential newborn care at home.

The improved care practices that lead to reduced risk of infection and better infant stimulation are hypothesized to lead to better neurodevelopmental outcomes, currently being assessed as described.

1. Kumar et al (2008). Effect of community-based behavior change management on neonatal mortality in Shivgarh Uttar Pradesh, India: a cluster-randomised controlled trial. Lancet, 372: 1151-1162.
2. Kumar, V., Kumar, A. & Darmstadt, G.L. Behavior change for newborn survival in resource-poor community settings: bridging the gap between evidence and impact. Seminars in perinatology 34, 446-61 (2010).
3. Darmstadt, G.L. et al. Introduction of community-based skin-to-skin care in rural Uttar Pradesh, India. Journal of perinatology : official journal of the California Perinatal Association 26, 597-604 (2006).
4. Kumar, V. et al. Community-driven impact of a newborn-focused behavioral intervention on maternal health in Shivgarh, India (in press). International Journal of Gynecology & Obstetrics (2011).