Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04798833
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2021-03-09
Brief Title:
Newborn Care Kit to Save Lives in GB Pakistan
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
An Integrated Newborn Care Kit to Save Newborn Lives and Improve Health Outcomes in Gilgit-Baltistan Pakistan
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iNCK
Brief Summary:
Neonatal deaths account for almost half of all deaths in children under 5 years of age Pakistan has the worlds highest neonatal mortality rate NMR and many of these deaths are preventable In this study the investigators propose the use of an evidence-based integrated newborn care kit iNCK to promote safer delivery provide early identification of danger signs improve newborn health and reduce NMR The investigators hypothesize that use of the iNCK will result in at least a 25 reduction in NMR among participants who receive the iNCK compared with participants who do not receive the iNCK
Detailed Description:
While some progress has been made towards reducing global under-5 mortality in 2019 an estimated 24 million newborn deaths still occurred worldwide accounting for 47 of all under-five deaths Most neonatal deaths are caused by prematurity sepsis and intrapartum-related complications
Pakistan has the highest neonatal mortality rate NMR in the world at 42 deaths per 1000 live births Gilgit-Baltistan GB Pakistans remote northern-most administrative territory is afflicted with some of the countrys worst NMRs High rates of home deliveries low adoption of safe birth practices inadequate cord care and high maternal mortality contribute to this health disparity GBs geography climate and underdeveloped infrastructure also largely restrict access to health care facilities Health care at the community level in Pakistan is primarily supported by the Lady Health Worker LHW Programme LHWs form a cadre of government-supported community health workers who provide newborn and maternal health services in GB However each of these health care workers is responsible for approximately 1000 people which restricts both availability and comprehensiveness of care particularly for families that live in hard to reach areas
Many proven cost-effective ways to save newborn lives and improve wellbeing exist however they are not always available to those who need them most nor are they packaged into a single portable kit that can be used in the home An easy-to-use kit consisting of low cost evidence-based interventions has potential to improve health status reduce NMR and provide more timely access to health services in remote areas such as GB Between April 2014 and August 2015 the investigators conducted a community-based cluster randomized intervention trial examining the effectiveness of delivering an integrated newborn care kit iNCK to pregnant women in Rahim Yar Khan RYK Punjab Pakistan The iNCKs were delivered by LHWs who also educated participants how to use the different kit components Neonatal mortality and morbidity outcomes were compared between iNCK recipients and a local control group who received the same standard of care but no iNCK The investigators found that while distribution of the iNCK did not significantly reduce neonatal mortality utilization of the iNCK significantly reduced the risk of omphalitis and fever Moreover using the LHW network to distribute the intervention proved a feasible delivery mechanism
The findings from the RYK trial suggest that while a network of community health workers can reliably deliver integrated interventions to pregnant women further investigation is needed to improve the integration of educational content and maximize the iNCKs potential health benefits Moreover effective delivery of maternal health interventions through the iNCK warrants examination as Pakistan experiences some of the worlds highest rates of maternal mortality of which post-partum hemorrhage PPH is a leading cause
Pakistan has the highest neonatal mortality rate NMR in the world at 42 deaths per 1000 live births Gilgit-Baltistan GB Pakistans remote northern-most administrative territory is afflicted with some of the countrys worst NMRs High rates of home deliveries low adoption of safe birth practices inadequate cord care and high maternal mortality contribute to this health disparity GBs geography climate and underdeveloped infrastructure also largely restrict access to health care facilities Health care at the community level in Pakistan is primarily supported by the Lady Health Worker LHW Programme LHWs form a cadre of government-supported community health workers who provide newborn and maternal health services in GB However each of these health care workers is responsible for approximately 1000 people which restricts both availability and comprehensiveness of care particularly for families that live in hard to reach areas
Many proven cost-effective ways to save newborn lives and improve wellbeing exist however they are not always available to those who need them most nor are they packaged into a single portable kit that can be used in the home An easy-to-use kit consisting of low cost evidence-based interventions has potential to improve health status reduce NMR and provide more timely access to health services in remote areas such as GB Between April 2014 and August 2015 the investigators conducted a community-based cluster randomized intervention trial examining the effectiveness of delivering an integrated newborn care kit iNCK to pregnant women in Rahim Yar Khan RYK Punjab Pakistan The iNCKs were delivered by LHWs who also educated participants how to use the different kit components Neonatal mortality and morbidity outcomes were compared between iNCK recipients and a local control group who received the same standard of care but no iNCK The investigators found that while distribution of the iNCK did not significantly reduce neonatal mortality utilization of the iNCK significantly reduced the risk of omphalitis and fever Moreover using the LHW network to distribute the intervention proved a feasible delivery mechanism
The findings from the RYK trial suggest that while a network of community health workers can reliably deliver integrated interventions to pregnant women further investigation is needed to improve the integration of educational content and maximize the iNCKs potential health benefits Moreover effective delivery of maternal health interventions through the iNCK warrants examination as Pakistan experiences some of the worlds highest rates of maternal mortality of which post-partum hemorrhage PPH is a leading cause
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None