Infant, Newborn, Disease, Inflammation, Neonatal Sepsis, Early-Onset, Very Low Birth Weight Infant
Conditions
Keywords
IgM-enriched Intravenous Immunoglobulin
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.
Interventions
DRUGIgM-enriched IVIG
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
Sponsors
Fakultas Kedokteran Universitas Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 1 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early Mortality Rate | 1 week | Neonates in the treatment group should have lower mortality rate in the first week of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Positive blood culture | 1 week | Neonates in the treatment group should have less number of positive blood culture than those in the place 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 |
| IT Ratio value | 1 week | Neonates in the treatment group should have lower IT Ratio value than those in the placebo group |
Contacts
Primary ContactRinawati Rohsiswatmo, MD, PhD
Outcome results
None listed