Clinical trial NCT04798833: Newborn Care Kit to Save Lives in GB, Pakistan
Official title: An Integrated Newborn Care Kit to Save Newborn Lives and Improve Health Outcomes in Gilgit-Baltistan, Pakistan
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Neonatal Mortality
Omphalitis
Post-Partum Hemorrhage
Keywords: Neonatal Mortality
Neonatal kit
Pakistan
Randomized Control Trial
Chlorhexidine
Omphalitis
Newborn
Birth
Post-Partum Hemorrhage
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: The Aga Khan Foundation
name: Aga Khan Health Services
name: Aga Khan University
First posted: 2021-03-15
Enrollment: 27448
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Resides in a village with LHW coverage in participating union councils (clusters) in Astore, Diamer, Shigar, Ghanche, Kharmang, and Skardu, districts of GB, Pakistan
* In their 3rd trimester of pregnancy (≥ week 27 gestational age)
* Intends to be present in the study catchment area between day 29 and 35 postnatal age
* Provides written informed consent or assent
* Starting in approximately month 26 of the study, only women ≥36 weeks of gestational age will be enrolled.

Exclusion Criteria:

* Does not reside within the study's catchment area at the time of enrolment
* Plans to relocate outside of the study catchment area within one month after the delivery of their newborn(s) and not return to the study catchment area
* Does not provide written informed consent or assent
* Lives in a village without LHW coverage

Primary outcomes:
measure: All-cause neonatal mortality
timeFrame: Day 29 postnatal age
Secondary outcomes:
measure: Cumulative incidence of omphalitis
timeFrame: Day 29 postnatal age
measure: Cumulative incidence of post-partum hemorrhage (PPH)
timeFrame: Day 29 postnatal age
measure: Health facility utilization
timeFrame: Day 29 postnatal age
measure: Cumulative incidence of hypothermia among participants in the experimental arm
timeFrame: Day 29 postnatal age
measure: Cumulative incidence of fever among participants in the experimental arm
timeFrame: Day 29 postnatal age
measure: Correlates of iNCK instructional compliance
timeFrame: Day 29 postnatal age
measure: Correlates of willingness to pay for the iNCK
timeFrame: 29 postnatal age
measure: Cause-specific neonatal mortality
timeFrame: Day 29 postnatal age
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Aga Khan Health Services, Pakistan
city: Karachi
country: Pakistan
facility: Aga Khan University
Study officials:
affiliation: The Hospital for Sick Children
name: Shaun Morris, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: