Modeling the risk of early-onset neonatal sepsis in Uganda and Zimbabwe
Using Machine Learning to Model Early-onset Neonatal Sepsis Risk in Late Preterm and Term Neonates in Uganda and Zimbabwe
This study is trying to create a tool to predict the risk of early-onset neonatal sepsis in newborns in Uganda and Zimbabwe by looking at mothers' and babies' health information.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Sex | Female |
| Sponsor | St George's, University of London Academic / other |
| Locations | 2 sites (Kawempe and 1 other locations) |
| Trial ID | NCT06411405 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a risk prediction model for early-onset neonatal sepsis in term and late preterm neonates in Uganda and Zimbabwe. It will recruit mother-baby pairs in Uganda, collecting extensive data on their medical histories and lifestyles, along with blood samples from newborns for culture. Machine learning techniques will be employed to analyze the data and create the risk prediction model, which will be validated in a second population in Zimbabwe. The study will also gather postnatal information to assess outcomes and potential readmissions.
Who should consider this trial
Good fit: Ideal candidates include neonates born at ≥34 weeks gestational age in Uganda and Zimbabwe.
Not a fit: Patients born at <34 weeks gestational age or with congenital abnormalities will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve early detection and management of neonatal sepsis in low-resource settings.
How similar studies have performed: Other studies have shown promise in using machine learning for risk prediction in healthcare, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kawempe and 1 other locations
- Makerere University, John Hopkins University — Kawempe, Uganda (Recruiting)
- St George's, University of London — London, United Kingdom (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.