IgM-Enriched Immunoglobulin for Neonatal Sepsis

University of Indonesia (UI)

Status and phase: Unknown; Phase 3

Conditions: Very Low Birth Weight Infant; Inflammation; Neonatal Sepsis, Early-Onset; Infant, Newborn, Disease

Treatments: Drug: IgM-enriched IVIG

Study type: Interventional

Funder types: Other

Identifiers

NCT04041765

19-11-432

Details and patient eligibility

About

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.

Full 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 low birth weight (VLBW) neonates with risk factors for EONS including maternal factors of premature rupture of membrane (PROM), fever, urinary tract infection (UTI), chorioamnionitis, and neonatal factor of prematurity and resuscitation history will be collected. These neonates within 1 hour of life will then be administered either placebo or IgM-enriched IVIG 0.25g/kg/day for 3 days, in addition to first-line empiric antibiotic. Randomization is done using simple randomization. Triple masking (Participant, Investigator, Outcomes Assessor) is conducted.

These neonates will then be clinically observed and evaluated for early mortality (mortality below 7 days), hemodynamics, length of stay, blood culture results, C-Reactive Protein (CRP), IT ratio, routine hematological examination, and IgGAME as parameters of improvement and prevention of EONS.

STATA version 12 (Macintosh version) will be used for data management and statistical analyses. The variables will first be presented descriptively, continued with bivariate and multivariate analysis. Bivariate analysis will be conducted between independent and dependent variables using chi-square/Fisher's exact test, Student's t-test, and Kruskal-Wallis. Variables with p-values <0.25 will be included in the multivariate analysis using logistic regression. The investigators will use two-sided p-values in our analysis with a p < 0.05 level of significance.

Enrollment: 70 estimated patients

Sex: All

Ages: 1 minute to 1 hour old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups, including a placebo group

Treatment Group

Experimental group

Description:

IgM-enriched IVIG given with dose of 0.25g/kg over 3 hours for 3 days in addition to Antibiotics

Treatment:

Drug: IgM-enriched IVIG

Placebo Group

Placebo Comparator group

Description:

Antibiotics only

Treatment:

Drug: IgM-enriched IVIG