Using Machine Learning to Model Early-onset Neonatal Sepsis Risk in Uganda and Zimbabwe
Launched by ST GEORGE'S, UNIVERSITY OF LONDON · May 7, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying early-onset neonatal sepsis, a serious infection that can affect newborns. The researchers aim to understand what factors increase the risk of this condition in babies born in Uganda and Zimbabwe. They plan to collect detailed medical and lifestyle information from mothers and their newborns, as well as blood samples from the babies right after birth. Using advanced computer techniques called machine learning, the team will develop a model to predict which babies are at higher risk of developing this infection. This model will then be tested in another group of newborns in Zimbabwe to see how well it works.
To participate in the study, mothers must have babies born at one of the selected hospitals in Uganda. The babies need to be at least 34 weeks old when born, which usually means they are more likely to be healthy. However, those born earlier or with certain health issues won't be included. If eligible, mothers can expect to share information about their health and lifestyle, and their babies will have a small blood test shortly after birth. This important research could help improve the care and outcomes for newborns at risk of sepsis in low-resource settings.
Gender
FEMALE
Eligibility criteria
- • 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
About St George's, University Of London
St George's, University of London is a leading academic institution dedicated to advancing healthcare through innovative research and education. As a prominent clinical trial sponsor, the university leverages its expertise in biomedical sciences, medicine, and health professions to conduct rigorous clinical studies aimed at improving patient outcomes. With a commitment to ethical practices and collaboration across disciplines, St George's fosters an environment that encourages groundbreaking discoveries and the translation of research findings into clinical applications, ultimately enhancing the quality of care in diverse medical fields.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
London, , United Kingdom
Kawempe, , Uganda
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported