Status:
COMPLETED
Neonatal Sepsis and GBS Carriage Study
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Wellcome Trust
Conditions:
Neonatal Sepsis
Eligibility:
All Genders
Brief Summary
In the proposed study, the investigators plan to establish the burden of early onset (EO) neonatal sepsis in the newborn population born at Maela Refugee Camp over a two year period. Aims 1. Define ...
Detailed Description
Globally 4 million neonates die each year, the most common cause of death is sepsis. Causes of neonatal sepsis in low and middle income countries are reported to differ from those in the developed wor...
Eligibility Criteria
Inclusion
- Part 1. The contribution of GBS to EO neonatal sepsis at Maela Refugee Camp study
- Infants, \< 7 days of age, who are born to mothers who followed antenatal care at SMRU antenatal clinic, Maela Refugee Camp and have a clinical diagnosis of sepsis
- Written informed consent from the mother
- Exclusion criteria:
- Severe congenital abnormality identified prenatally or at birth
- Infants less than 28 weeks gestation Part 2. The GBS carriage, seroepidemiology and GBS antibody study
- Inclusion criteria:
- Mothers following antenatal care at SMRU antenatal clinic, Maela camp who are 28 - 30 weeks gestation
- Written informed consent from the mother
- Exclusion criteria:
- 1\. Mothers receiving antibiotics at the time of sampling
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
849 Patients enrolled
Trial Details
Trial ID
NCT00861055
Start Date
March 1 2009
End Date
April 1 2012
Last Update
May 8 2024
Active Locations (1)
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1
Shoklo Malaria Research Unit
Mae Sot, Changwat Tak, Thailand, 63110