Newborn Care Kit to Save Lives in GB, Pakistan (NCT04798833) | Clinical Trial Compass
CompletedNot Applicable
Newborn Care Kit to Save Lives in GB, Pakistan
Pakistan19,344 participantsStarted 2022-03-01
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.
1This trial tested a newborn care kit in Pakistan to reduce deaths in the first month of life — do you think the findings from that setting could be relevant to the care plan we're considering for our newborn?
2The study measured all-cause neonatal mortality as its main outcome, which includes things like omphalitis (umbilical cord infection) and postpartum hemorrhage in the mother — are these specific risks something we should be actively screening for or preventing in our situation?
3Since this trial is now completed, would you be able to help us find out what the results showed, and whether the care kit or practices it studied are something you'd recommend for us?
4The trial was conducted in a low-resource setting in Pakistan — how much of what was learned there would translate to the care available to us here, and are there any equivalent preventive tools or protocols you already use?
5Given that this was a Phase NA (non-drug, non-device phase) study focused on a care kit intervention, are there any simple, evidence-based newborn care practices from research like this that you think we should be following at home in those first critical weeks?
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.