Newborn Care Kit to Save Lives in GB, Pakistan — iNCK  

Neonatal Mortality Clinical Trial

Official title: An Integrated Newborn Care Kit to Save Newborn Lives and Improve Health Outcomes in Gilgit-Baltistan, Pakistan

Status Recruiting

Clinical Trial Summary

Neonatal deaths account for almost half of all deaths in children under 5 years of age. Pakistan has the world's 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.

Clinical Trial Description

While some progress has been made towards reducing global under-5 mortality, in 2019, an estimated 2.4 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 1,000 live births. Gilgit-Baltistan (GB), Pakistan's remote, northern-most administrative territory, is afflicted with some of the country's 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. GB's 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 1,000 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 iNCK's potential health benefits. Moreover, effective delivery of maternal health interventions through the iNCK warrants examination, as Pakistan experiences some of the world's highest rates of maternal mortality, of which post-partum hemorrhage (PPH) is a leading cause. ;

Related Conditions & MeSH terms

• Neonatal Mortality
• Omphalitis

• NCT number: NCT04798833
• Study type: Interventional
• Source: The Hospital for Sick Children
• Contact: Shaun Morris, MD, MPH
• Phone: 416-813-7500 extension: 206625
• Email: shaun.morris@sickkids.ca
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2021
• Completion date: June 2024