Using Machine Learning to Model Early-onset Neonatal Sepsis Risk in Uganda and Zimbabwe (NCT06411405) | Clinical Trial Compass
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Using Machine Learning to Model Early-onset Neonatal Sepsis Risk in Uganda and Zimbabwe
Uganda, United Kingdom2,500 participantsStarted 2024-04-11
Plain-language summary
The goal of this observational study is to develop a risk prediction model for early-onset neonatal sepsis in term and late preterm neonates in Uganda and Zimbabwe.
The main questions it aims to answer are:
* What are the risk factors for early-onset neonatal sepsis in low-resource settings?
* How can these be combined into a risk prediction model?
Mother-baby pairs will be recruited in Uganda. They will have extensive data taken on their medical and obstetric histories and lifestyles, and their newborns will have a blood sample taken just after birth for culture. Machine learning techniques will be used to create the risk prediction model, which will then be validated in a second population in Zimbabwe.
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
* Neonates born at one of the study sites
* Neonates born at ≥34 weeks gestational age, defined by:
* Ultrasound scan, where participant has had an ultrasound scan during routine antenatal care
* If no ultrasound scan has been done, according to last menstrual period date, according to mother
* If no ultrasound scan has been done and the mother does not know her last menstrual period date, the neonate will be eligible for inclusion if their birth weight is ≥1400g which will include the majority of births ≥34 weeks according to the results of the INTERGROWTH-21st Project(44)
Exclusion criteria
* Neonates born at \<34 weeks gestational age, due to their higher background risk of sepsis, and automatic admission to the neonatal unit with antibiotic administration
* Neonates with congenital abnormalities or syndromes associated with increased susceptibility to infection will be excluded (e.g. gastroschisis).
* Neonates whose mothers are unable to provide informed consent
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.