Using Machine Learning to Model Early-onset Neonatal Sepsis Risk in Uganda and Zimbabwe

NCT06411405 | Recruiting

• 1 other identifier: HS3728ES
• Study Type: observational
• Target: 2,500
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Neonatal Sepsis

Outcome Measures

Primary Outcomes (1)

• Positive blood culture amongst neonatal participants

  Venous blood culture processed on BACTEC machine

  Sample taken in first 48 hours of life

Secondary Outcomes (5)

• Documented clinical diagnosis of sepsis amongst neonatal participants

  Within first 72 hours of life

• Clinical features of neonatal sepsis

  Within first 72 hours of life

• Admission to neonatal unit

  Within first 72 hours of life

• Readmission to hospital in first 28 days amongst neonatal participants

  Within 28 days of birth

• Death before 28 days of age

  Within 28 days of birth

Study Arms (2)

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.

Other: Maternal medical history

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.

Other: Maternal medical history

Interventions

Maternal medical history OTHER

See above; multiple factors to be collected broadly grouped into maternal medical, obstetric, and sociodemographic/lifestyle factors.

Also known as: Maternal obstetric/pregnancy history, Maternal sociodemographic/lifestyle factors

Ugandan mother-baby cohort; Zimbabwean mother-baby cohort

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study populations will be recruited from Kawempe National Referral Hospital in Kampala, Uganda and Sally Mugabe Central Hospital in Harare, Zimbabwe.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St George's, University of London: lead
• MU-JHU CARE: collaborator
• Biomedical Research and Training Institute, Zimbabwe: collaborator

Study Sites (2)

Makerere University, John Hopkins University

Kawempe, Uganda

RECRUITING

St George's, University of London

London, SW17 0RE, United Kingdom

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Dried blood spots will be retained for any samples where there is leftover sample

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Reproductive History

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Medical History Taking; Diagnostic Techniques and Procedures; Diagnosis; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: May 13, 2024
• Study Start: April 11, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 1, 2025
• Last Updated: May 17, 2024

Record last verified: 2024-02

Locations

GB (1); UG (1)