Community-Based Delivery of an Innovative Neonatal Kit to Save Newborn Lives and Improve Neurodevelopment in Rural Pakistan and Kenya: Methodology and Early Results of Two Cluster Randomized Trials

Presenter: Lisa Pell, The Hospital for Sick Children, Centre for Global Child Health

Background: In Pakistan and Kenya, neonatal mortality rates are high (42 and 26 per 1000 live births, respectively) and have only minimally decreased over the last decade. Furthermore, the same insults that cause most newborn deaths, namely infection and complications of preterm birth and low birthweight (LBW), can also effect neurodevelopment.

Methodology: These cluster randomized trials aim to evaluate the impact of delivering an integrated neonatal kit to pregnant women during their third trimester and providing education on how to use the contents compared to current standard of care in Rahimyar Khan, Pakistan (n=6000) and Kwale County, Kenya (n=3000). The intervention comprises a clean delivery kit, sunflower oil emollient, chlorhexidine, ThermoSpot, Mylar blanket, and instant heat pack. Community health workers, who deliver the intervention, are also equipped with a hand-held scale. In Kenya, the impact of delivering a newborn developmental stimulation program is being simultaneously evaluated. Major outcomes include neonatal mortality and neurodevelopment at 12 months of age. Secondary outcomes include newborn infection, hypothermia, identification of LBW, health-facility referral, and compliance.

Results: While enrolment and data collection are ongoing, preliminary descriptive analyses have been performed on aggregated data. In Pakistan, consent has been collected from 5288 participants, 2709 kits were delivered and 4003 newborns enrolled. Among 3116 participants, 58 newborn deaths, 36 cases of observed omphalitis, 239 events of self-reported omphalitis, and 2 cases of hypothermia have been recorded. In Kenya, consent has been collected from 1104 participants, 750 kits have been delivered and 674 newborns enrolled. Among 360 participants, 9 newborn deaths, 51 cases of observed omphalitis, 25 events of self-reported omphalitis, and 5 cases of hypothermia were recorded.

Conclusion: Upon conclusion and analysis by intervention arm, these studies will provide evidence on the feasibility and effectiveness of delivering a neonatal kit to pregnant women in Pakistan and Kenya.