Inflammation Clinical Trial
Official title:
Efficacy of Prophylactic IgM-Enriched Immunoglobulin for the Management of Early-Onset Neonatal Sepsis in Very Low Birth Weight Preterm Neonates; A Randomized Controlled Trial
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.
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.
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