Status:
UNKNOWN
IgM-Enriched Immunoglobulin for Neonatal Sepsis
Lead Sponsor:
Fakultas Kedokteran Universitas Indonesia
Conditions:
Neonatal Sepsis, Early-Onset
Very Low Birth Weight Infant
Eligibility:
All Genders
1-1 years
Phase:
PHASE3
Brief Summary
This study compares giving prophylactic IgM enriched Intravenous Immunoglobulin (IVIG) with placebo in 1 hour after birth, in neonates with risk factors of Early-Onset Neonatal Sepsis (EONS). In addit...
Detailed Description
This randomized-controlled trial conducted in Cipto Mangunkusumo Hospital, Jakarta, Indonesia aims to determine the efficacy of prophylactic IgM-Enriched IVIG in preventing EONS. A total of 70 very lo...
Eligibility Criteria
Inclusion
- Very low birth weight infants (\< 1500 g)
- Gestational age below 32 weeks
- Risk of Early-Onset sepsis from maternal and neonate factors
- Inborn neonates
Exclusion
- Birth weight \< 600 g
- Gestational age \< 26 weeks
- Multiple Congenital Anomaly
- Neonates with suspected congenital syndrome
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2020
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04041765
Start Date
September 1 2019
End Date
August 1 2020
Last Update
August 1 2019
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