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