Status:
ACTIVE_NOT_RECRUITING
Newborn Care Kit to Save Lives in GB, Pakistan
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
The Aga Khan Foundation
Aga Khan Health Services
Conditions:
Neonatal Mortality
Omphalitis
Eligibility:
FEMALE
Phase:
NA
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 thi...
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. Mos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
27448 Patients enrolled
Trial Details
Trial ID
NCT04798833
Start Date
June 1 2021
End Date
December 1 2025
Last Update
June 6 2025
Active Locations (2)
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1
Aga Khan Health Services, Pakistan
Islamabad, Pakistan
2
Aga Khan University
Karachi, Pakistan