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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | IgM-enriched IVIG given with dose of 0.25g/kg over 3 hours for 3 days in addition to Antibiotics |
|
| Placebo Group | Placebo Comparator | Antibiotics only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IgM-enriched IVIG | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Early Mortality Rate | Neonates in the treatment group should have lower mortality rate in the first week of life | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Positive blood culture | Neonates in the treatment group should have less number of positive blood culture than those in the place group | 1 week |
| Duration of NICU stay | Neonates in the treatment group should be discharged earlier than those in the placebo group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rinawati Rohsiswatmo, MD, PhD | Contact | +62811133094 | rinarohsis@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rinawati Rohsiswatmo, MD, PhD | Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo Hospital | Study Chair |
| Nina D Putri, MD, PhD | Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo Hospital |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24098953 | Background | Capasso L, Borrelli AC, Parrella C, Lama S, Ferrara T, Coppola C, Catania MR, Iula VD, Raimondi F. Are IgM-enriched immunoglobulins an effective adjuvant in septic VLBW infants? Ital J Pediatr. 2013 Oct 7;39:63. doi: 10.1186/1824-7288-39-63. | |
| 3195529 | Background | Haque KN, Zaidi MH, Bahakim H. IgM-enriched intravenous immunoglobulin therapy in neonatal sepsis. Am J Dis Child. 1988 Dec;142(12):1293-6. doi: 10.1001/archpedi.1988.02150120047038. |
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| ID | Term |
|---|---|
| D000071074 | Neonatal Sepsis |
| D007249 | Inflammation |
| D004194 | Disease |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C060166 | pentaglobulin |
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|
| 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 | 1 week |
| IT Ratio value | Neonates in the treatment group should have lower IT Ratio value than those in the placebo group | 1 week |
| Leukocyte count | Neonates in the treatment group should have lower Leukocyte count than those in the placebo group | 1 week |
| IgGAME (IgG, IgM, IgA, IgE) Levels | Neonates in the treatment group should have higher IgGAME levels than those in the placebo group | 1 week |
| 15546815 | Background | Reith HB, Rauchschwalbe SK, Mittelkotter U, Engemann R, Thiede A, Arnold A, Lissner R. IgM-enriched immunoglobulin (pentaglobin) positively influences the course of post-surgical intra-abdominal infections. Eur J Med Res. 2004 Oct 29;9(10):479-84. |
| 29460549 | Background | Capasso L, Borrelli AC, Pirozzi MR, Bucci L, Albachiara R, Ferrara T, Raimondi F. IgM and IgA enriched polyclonal immunoglobulins reduce short term mortality in extremely low birth weight infants with sepsis: a retrospective cohort study. Minerva Pediatr (Torino). 2021 Feb;73(1):3-7. doi: 10.23736/S2724-5276.18.04850-8. Epub 2018 Feb 19. |
| 25220128 | Background | Capasso L, Borrelli AC, Ferrara T, Coppola C, Cerullo J, Izzo F, Caiazza R, Lama S, Raimondi F. Immunoglobulins in neonatal sepsis: has the final word been said? Early Hum Dev. 2014 Sep;90 Suppl 2:S47-9. doi: 10.1016/S0378-3782(14)50013-8. |
| D018746 | Systemic Inflammatory Response Syndrome |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |