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IgM-Enriched Immunoglobulin for Neonatal Sepsis

NCT04041765 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2019-08-01

No results posted yet for this study

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.

Conditions

  • Neonatal Sepsis, Early-Onset
  • Very Low Birth Weight Infant
  • Inflammation
  • Infant, Newborn, Disease

Interventions

DRUG

IgM-enriched IVIG

Contains human plasma protein 50mg/ml. With composition of Immunoglobulin M (IgM) 6mg, Immunoglobulin A (IgA) 6mg, Immunoglobulin G (IgG) 38mg (IgG subcl. approx. 63 % IgG1, 26 % IgG2, 4 % IgG3 and 7 % IgG4), Glucose monohydrate, sodium chloride, water for injections

Sponsors & Collaborators

  • Fakultas Kedokteran Universitas Indonesia

    lead OTHER

Principal Investigators

  • Rinawati Rohsiswatmo, MD, PhD · Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo Hospital

  • Nina D Putri, MD, PhD · Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
1 Hour
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2020-06-30
Completion
2020-08-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04041765 on ClinicalTrials.gov