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
Author:
Fadaleh Sarah Abu1, Pell Lisa G.1, Yasin Muhammad2, Farrar Daniel S.1, Khan Sher Hafiz2, Tanner Zachary1, Paracha Shariq3, Madhani Falak3, Bassani Diego G.1, Ahmed Imran4, Soofi Sajid B.4, Taljaard Monica5, Spitzer Rachel F.6, Bhutta Zulfiqar A.1, Morris Shaun K.7
Affiliation:
1. Centre for Global Child Health, The Hospital for Sick Children 2. Gilgit Regional Office, Aga Khan Health Service – Pakistan, Gilgit-Baltistan 3. Aga Khan Health Service – Pakistan, Karachi, Sindh 4. Centre of Excellence in Women and Child Health, Aga Khan University, Karachi, Sindh 5. Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario 6. Department of Obstetrics and Gynecology, University of Toronto, Toronto, Ontario 7. Division of Infectious Diseases,The Hospital for Sick Children
Abstract
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.
Publisher
Research Square Platform LLC
Reference30 articles.
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