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IgM-Enriched Immunoglobulin for Neonatal Sepsis

U

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

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

Trial contacts and locations

0

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Central trial contact

Rinawati Rohsiswatmo, MD, PhD

Data sourced from clinicaltrials.gov

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