학술논문
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.
Document Type
Academic Journal
Author
Fadaleh SMA; Centre for Global Child Health, The Hospital for Sick Children, Toronto, ON, Canada.; Pell LG; Centre for Global Child Health, The Hospital for Sick Children, Toronto, ON, Canada.; Yasin M; Gilgit Regional Office, Aga Khan Health Service - Pakistan, Gilgit-Baltistan, Pakistan.; Farrar DS; Centre for Global Child Health, The Hospital for Sick Children, Toronto, ON, Canada.; Khan SH; Gilgit Regional Office, Aga Khan Health Service - Pakistan, Gilgit-Baltistan, Pakistan.; Tanner Z; Centre for Global Child Health, The Hospital for Sick Children, Toronto, ON, Canada.; Paracha S; Aga Khan Health Service - Pakistan, Karachi, Sindh, Pakistan.; Madhani F; Aga Khan Health Service - Pakistan, Karachi, Sindh, Pakistan.; Brain and Mind Institute, Aga Khan University, Karachi, Sindh, Pakistan.; Bassani DG; Centre for Global Child Health, The Hospital for Sick Children, Toronto, ON, Canada.; Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.; Department of Pediatrics, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.; Child Health Evaluative Sciences, The Hospital for Sick Children, Research Institute, Toronto, ON, Canada.; Ahmed I; Centre of Excellence in Women and Child Health, Aga Khan University, Karachi, Sindh, Pakistan.; Soofi SB; Centre of Excellence in Women and Child Health, Aga Khan University, Karachi, Sindh, Pakistan.; Taljaard M; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.; School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.; Spitzer RF; Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON, Canada.; Section of Gynecology, The Hospital for Sick Children, Toronto, ON, Canada.; Bhutta ZA; Centre for Global Child Health, The Hospital for Sick Children, Toronto, ON, Canada.; Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.; Department of Pediatrics, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.; Child Health Evaluative Sciences, The Hospital for Sick Children, Research Institute, Toronto, ON, Canada.; Centre of Excellence in Women and Child Health, Aga Khan University, Karachi, Sindh, Pakistan.; Institute for Global Health & Development, The Aga Khan University, South-Central Asia & East Africa, Karachi, Pakistan.; Aga Khan University, Karachi, Sindh, Pakistan.; Morris SK; Centre for Global Child Health, The Hospital for Sick Children, Toronto, ON, Canada. shaun.morris@sickkids.ca.; Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada. shaun.morris@sickkids.ca.; Department of Pediatrics, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada. shaun.morris@sickkids.ca.; Child Health Evaluative Sciences, The Hospital for Sick Children, Research Institute, Toronto, ON, Canada. shaun.morris@sickkids.ca.; Division of Infectious Diseases, The Hospital for Sick Children, 555 University Ave, Toronto, ON, M5G 1X8, Canada. shaun.morris@sickkids.ca.
Source
Publisher: BioMed Central Country of Publication: England NLM ID: 100968562 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2458 (Electronic) Linking ISSN: 14712458 NLM ISO Abbreviation: BMC Public Health Subsets: MEDLINE
Subject
Language
English
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.
(© 2023. The Author(s).)
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.
(© 2023. The Author(s).)