Newborn Care Kit to Save Lives in GB, Pakistan (NCT04798833) | Clinical Trial Compass
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
Sex
FEMALE
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.