Active — Not RecruitingNot Applicable

Newborn Care Kit to Save Lives in GB, Pakistan

Pakistan27,448 participantsStarted 2021-06-01

Plain-language 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.

Who can participate

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

All-cause neonatal mortality

Timeframe: Day 29 postnatal age

Trial details

NCT IDNCT04798833

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-30

View on ClinicalTrials.gov More Neonatal Mortality trials

Plain-language summary

Who can participate

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.