IgM-Enriched Immunoglobulin for Neonatal Sepsis
- Conditions
- Neonatal Sepsis, Early-OnsetVery Low Birth Weight InfantInflammationInfant, Newborn, Disease
- Interventions
- Registration Number
- NCT04041765
- Lead Sponsor
- Fakultas Kedokteran Universitas Indonesia
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
- Very low birth weight infants (< 1500 g)
- Gestational age below 32 weeks
- Risk of Early-Onset sepsis from maternal and neonate factors
- Inborn neonates
- Birth weight < 600 g
- Gestational age < 26 weeks
- Multiple Congenital Anomaly
- Neonates with suspected congenital syndrome
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Group IgM-enriched IVIG IgM-enriched IVIG given with dose of 0.25g/kg over 3 hours for 3 days in addition to Antibiotics Placebo Group IgM-enriched IVIG Antibiotics only
- Primary Outcome Measures
Name Time Method Early Mortality Rate 1 week Neonates in the treatment group should have lower mortality rate in the first week of life
- Secondary Outcome Measures
Name Time Method Positive blood culture 1 week Neonates in the treatment group should have less number of positive blood culture than those in the place group
Duration of NICU stay Through study completion, an average of 3 months Neonates in the treatment group should be discharged earlier than those in the placebo group
Quantitative CRP Levels 1 week Neonates in the treatment group should have lower CRP levels than those in the placebo group
IT Ratio value 1 week Neonates in the treatment group should have lower IT Ratio value than those in the placebo group
Leukocyte count 1 week Neonates in the treatment group should have lower Leukocyte count than those in the placebo group
IgGAME (IgG, IgM, IgA, IgE) Levels 1 week Neonates in the treatment group should have higher IgGAME levels than those in the placebo group