Using Machine Learning to Model Early-onset Neonatal Sepsis Risk in Late Preterm and Term Neonates in Uganda and Zimbabwe

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: t
View:

• 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)

Locations
Other Locations
Uganda
Makerere University, John Hopkins University
RECRUITING
Kawempe
United Kingdom
St George's, University of London
NOT_YET_RECRUITING
London
Time Frame
Start Date: 2024-04-11
Estimated Completion Date: 2025-03-01
Participants
Target number of participants: 2500
Treatments
Ugandan mother-baby cohort
Mother-baby pairs recruited antenatally or at delivery, with babies eligible for inclusion if they are born at 34 weeks gestational age and above. Used as primary data for modelling.
Zimbabwean mother-baby cohort
Mother-baby pairs with babies eligible for inclusion if they are born at 34 weeks gestational age and above, used as a validation cohort for the model.
Related Therapeutic Areas
Sponsors
Collaborators: Biomedical Research and Training Institute, Zimbabwe, MU-JHU CARE
Leads: St George's, University of London

This content was sourced from clinicaltrials.gov