An integrated newborn care kit (iNCK) to save newborn lives and improve health outcomes in Gilgit Baltistan (GB), Pakistan: study protocol for a cluster randomized controlled trial

Abstract

Background Ongoing high neonatal mortality rates (NMRs) represent a global challenge. In 2021, of the 5 million deaths reported worldwide for children under five years of age, 47% were newborns. Pakistan has one of the five highest national NMRs in the world, with an estimated 39 neonatal deaths per 1,000 live births. Reducing newborn deaths requires sustainable, evidence-based, and cost-effective interventions that can be integrated within existing community healthcare infrastructure across regions with high NMR. Methods This pragmatic, community-based, parallel-arm, open-label, cluster randomized controlled trial aims to estimate the effect of Lady Health Workers (LHWs) providing an integrated newborn care kit (iNCK) with educational instructions to pregnant women in their third trimester, compared to the local standard of care in Gilgit-Baltistan, Pakistan, on neonatal mortality and other newborn and maternal health outcomes. The iNCK contains a clean birth kit, 4% chlorhexidine topical gel, sunflower oil emollient, a ThermoSpot™ temperature monitoring sticker, a fleece blanket, a click-to-heat reusable warmer, three 200 μg misoprostol tablets, and a pictorial instruction guide and diary. LHWs are also provided with a handheld scale to weigh the newborn. The primary study outcome is neonatal mortality, defined as a newborn death in the first 28 days of life. Discussion This study will generate policy-relevant knowledge on the effectiveness of integrating evidence-based maternal and newborn interventions and delivering them directly to pregnant women via existing community health infrastructure, for reducing neonatal mortality and morbidity, in a remote, mountainous area with a high NMR. Trial registration NCT04798833, March 15, 2021.

Association of maternal, obstetric, fetal, and neonatal mortality outcomes with Lady Health Worker coverage from a cross-sectional survey of >10,000 households in Gilgit-Baltistan, Pakistan

“…The primary objective of this survey was to collect baseline outcome parameters to inform the cRCT. Specifically, baseline data regarding cluster-level neonatal mortality and health facility deliveries were utilized as inputs for the trial’s covariate constrained randomization, and will also be adjusted for in the trial’s pre-specified multivariable analyses [ 13 ].…”

“…Between 2022–2024, a cluster randomized controlled trial (cRCT) in Gilgit-Baltistan, Pakistan aimed to estimate the effect of an integrated newborn care kit on maternal and newborn health outcomes, primarily neonatal mortality (Clinicaltrials.gov NCT04798833). The intervention is designed to be integrated into existing community healthcare infrastructure, and includes tools to be utilized throughout the neonatal period to prevent newborn infection (e.g., clean delivery kit, chlorhexidine gel, sunflower oil emollient), identify and manage hypothermia and fever (ThermoSpot thermoindicator sticker, blanket, and portable heat pack), and teach caregivers on each component’s appropriate usage (pictorial guide) [ 13 ]. The kit also includes oral misoprostol tablets to prevent postpartum hemorrhage (PPH), the leading cause of maternal death [ 14 ].…”