Status:
COMPLETED
SEPSIS Observational Cohort Study in Young Infants in Bangladesh
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
International Centre for Diarrhoeal Disease Research, Bangladesh
Child Health Research Foundation, Bangladesh
Conditions:
Severe Infection and Non-injury Death
Eligibility:
All Genders
Up to 49 years
Brief Summary
Globally, infectious diseases such as sepsis, meningitis and pneumonia are among the leading causes of neonatal deaths. A recent observational study in South Asia highlighted the contribution of both ...
Detailed Description
Globally, infectious diseases including sepsis, meningitis, and pneumonia are among the leading causes of neonatal deaths. In 2017, these three conditions were estimated to account for 540,000 newborn...
Eligibility Criteria
Inclusion
- Core
- Infants up to and including 4 days of age
- Infants delivered at a study hospital
- Orally feeding currently
- Informed consent by parent or guardian
- Intends to maintain residence within the defined catchment areas (upon discharge from hospital) until 60 days of age
- Core
Exclusion
- Birth weight \<1500g
- Death or major surgery considered to be highly probable within first week of life
- Major congenital anomaly of the gastrointestinal tract
- Maternal HIV infection and/or history of mother ever receiving anti-retroviral drug(s) for presumed HIV infection
- Current mechanical ventilation and/or cardiac support (e.g., inotropes) and/or administration/prescription of parenteral antibiotics
- Any prenatal or postpartum use of non-dietary probiotic supplement by mother (during current pregnancy)
- Any postnatal administration of non-dietary probiotic or prebiotic supplements to infant
- Enrolment of infant in any other clinical trial involving the administration of probiotics and/or prebiotics
- Resides in the same household as another infant previously enrolled in the study, or any study within the research platform, who is currently \<60 days of age; however, twins may all be enrolled simultaneously
- Multiple gestation for which the number of liveborn infants from the same pregnancy exceeds two (i.e., triplets or higher order multiples)
Key Trial Info
Start Date :
February 12 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 22 2022
Estimated Enrollment :
2083 Patients enrolled
Trial Details
Trial ID
NCT04012190
Start Date
February 12 2020
End Date
October 22 2022
Last Update
October 31 2022
Active Locations (2)
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1
Maternal Child Health Training Institute
Dhaka, Bangladesh
2
Mohammadpur Fertility Services Training Centre
Dhaka, Bangladesh