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 d...
| Main Authors: | , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2023-12-01
|
| Series: | BMC Public Health |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12889-023-17322-y |
| _version_ | 1797387989352972288 |
|---|---|
| author | Sarah M. Abu Fadaleh Lisa G. Pell Muhammad Yasin Daniel S. Farrar Sher Hafiz Khan Zachary Tanner Shariq Paracha Falak Madhani Diego G. Bassani Imran Ahmed Sajid B. Soofi Monica Taljaard Rachel F. Spitzer Zulfiqar A. Bhutta Shaun K. Morris |
| author_facet | Sarah M. Abu Fadaleh Lisa G. Pell Muhammad Yasin Daniel S. Farrar Sher Hafiz Khan Zachary Tanner Shariq Paracha Falak Madhani Diego G. Bassani Imran Ahmed Sajid B. Soofi Monica Taljaard Rachel F. Spitzer Zulfiqar A. Bhutta Shaun K. Morris |
| author_sort | Sarah M. Abu Fadaleh |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-08T22:34:11Z |
| format | Article |
| id | doaj.art-4073f718c9b54ab9ac7e48e8fe4ac2f9 |
| institution | Directory Open Access Journal |
| issn | 1471-2458 |
| language | English |
| last_indexed | 2024-03-08T22:34:11Z |
| publishDate | 2023-12-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Public Health |
| spelling | doaj.art-4073f718c9b54ab9ac7e48e8fe4ac2f92023-12-17T12:32:24ZengBMCBMC Public Health1471-24582023-12-0123111110.1186/s12889-023-17322-yAn 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 trialSarah M. Abu Fadaleh0Lisa G. Pell1Muhammad Yasin2Daniel S. Farrar3Sher Hafiz Khan4Zachary Tanner5Shariq Paracha6Falak Madhani7Diego G. Bassani8Imran Ahmed9Sajid B. Soofi10Monica Taljaard11Rachel F. Spitzer12Zulfiqar A. Bhutta13Shaun K. Morris14Centre for Global Child Health, The Hospital for Sick ChildrenCentre for Global Child Health, The Hospital for Sick ChildrenGilgit Regional Office, Aga Khan Health Service – PakistanCentre for Global Child Health, The Hospital for Sick ChildrenGilgit Regional Office, Aga Khan Health Service – PakistanCentre for Global Child Health, The Hospital for Sick ChildrenAga Khan Health Service – PakistanAga Khan Health Service – PakistanCentre for Global Child Health, The Hospital for Sick ChildrenCentre of Excellence in Women and Child Health, Aga Khan UniversityCentre of Excellence in Women and Child Health, Aga Khan UniversityClinical Epidemiology Program, Ottawa Hospital Research InstituteDepartment of Obstetrics and Gynaecology, University of TorontoCentre for Global Child Health, The Hospital for Sick ChildrenCentre for Global Child Health, The Hospital for Sick ChildrenAbstract 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.https://doi.org/10.1186/s12889-023-17322-yNeonatal mortalityGilgit-BaltistanPakistanNewbornSepsisHypothermia |
| spellingShingle | Sarah M. Abu Fadaleh Lisa G. Pell Muhammad Yasin Daniel S. Farrar Sher Hafiz Khan Zachary Tanner Shariq Paracha Falak Madhani Diego G. Bassani Imran Ahmed Sajid B. Soofi Monica Taljaard Rachel F. Spitzer Zulfiqar A. Bhutta Shaun K. Morris 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 BMC Public Health Neonatal mortality Gilgit-Baltistan Pakistan Newborn Sepsis Hypothermia |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Neonatal mortality Gilgit-Baltistan Pakistan Newborn Sepsis Hypothermia |
| url | https://doi.org/10.1186/s12889-023-17322-y |
| work_keys_str_mv | AT sarahmabufadaleh anintegratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT lisagpell anintegratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT muhammadyasin anintegratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT danielsfarrar anintegratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT sherhafizkhan anintegratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT zacharytanner anintegratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT shariqparacha anintegratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT falakmadhani anintegratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT diegogbassani anintegratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT imranahmed anintegratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT sajidbsoofi anintegratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT monicataljaard anintegratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT rachelfspitzer anintegratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT zulfiqarabhutta anintegratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT shaunkmorris anintegratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT sarahmabufadaleh integratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT lisagpell integratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT muhammadyasin integratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT danielsfarrar integratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT sherhafizkhan integratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT zacharytanner integratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT shariqparacha integratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT falakmadhani integratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT diegogbassani integratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT imranahmed integratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT sajidbsoofi integratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT monicataljaard integratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT rachelfspitzer integratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT zulfiqarabhutta integratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial AT shaunkmorris integratednewborncarekitincktosavenewbornlivesandimprovehealthoutcomesingilgitbaltistangbpakistanstudyprotocolforaclusterrandomizedcontrolledtrial |