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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
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
Early Mortality Rate
Neonates in the treatment group should have lower mortality rate in the first week of life
Time frame: 1 week
Positive blood culture
Neonates in the treatment group should have less number of positive blood culture than those in the place group
Time frame: 1 week
Duration of NICU stay
Neonates in the treatment group should be discharged earlier than those in the placebo group
Time frame: Through study completion, an average of 3 months
Quantitative CRP Levels
Neonates in the treatment group should have lower CRP levels than those in the placebo group
Time frame: 1 week
IT Ratio value
Neonates in the treatment group should have lower IT Ratio value than those in the placebo group
Time frame: 1 week
Leukocyte count
Neonates in the treatment group should have lower Leukocyte count than those in the placebo group
Time frame: 1 week
IgGAME (IgG, IgM, IgA, IgE) Levels
Neonates in the treatment group should have higher IgGAME levels than those in the placebo group
Time frame: 1 week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Enrollment
70