Overview

IgM-Enriched Immunoglobulin for Neonatal Sepsis

Status:
Unknown status
Trial end date:
2020-08-01
Target enrollment:
0
Participant gender:
All
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 addition to the intervention, standard regimen antibiotics are also given within 1 hour. The IVIG is given for 3 days and primary and secondary outcomes will be collected. Risk factors are both from maternal and neonate origin.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fakultas Kedokteran Universitas Indonesia
Treatments:
Antibodies
Immunoglobulins
Criteria
Inclusion Criteria:

- 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 Criteria:

- Birth weight < 600 g

- Gestational age < 26 weeks

- Multiple Congenital Anomaly

- Neonates with suspected congenital syndrome