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Study comprises of giving IVIG to half of the septic VLBW preterm neonates along with ongoing antibiotics and placebo to the other half. The immunoglobulin will be given for 3 days and neonates will be monitored for the results. The data will be analysed on the basis of blood culture results and outcome of the patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| case group | Active Comparator | 'IgM rich immunoglobulin' intravenous infusion in the dose of 5 ml/ kg/ dose over 3 hours once a day for 3 days. |
|
| control group | Placebo Comparator | antibiotics only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IgM rich Immunoglobin | Drug | the 'IgM rich immunoglobn' is the normal human immunoglobin containing Human plasma protein 50mg/ml of which immunoglobin is atleast 95% Immunoglobin M (IgM) 6mg Immunoglobin A (IgA) 6mg Immunoglobin G (IgG) 38mg |
| Measure | Description | Time Frame |
|---|---|---|
| Discharge rates | patients who received IgM rich Immunoglobin along with antibiotics have better outcome as compared to the patients who receive only antibiotics. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of hospital stay | patients who received IgM rich Immunoglobin along with antibiotics have better outcome as compared to the patients who receive only antibiotics. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jayendra R Gohil, MD | SirTakhtasinhjiGH, Prof Pediatrics, Govt MC, Bhavnagar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NICU, Sir T Hospital, Bhavnagar | Bhavnagar | Gujarat | 364002 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25674546 | Result | Capasso L, Borrelli A, Cerullo J, Pisanti R, Figliuolo C, Izzo F, Paccone M, Ferrara T, Lama S, Raimondi F. Role of immunoglobulins in neonatal sepsis. Transl Med UniSa. 2014 Dec 19;11:28-33. eCollection 2015 Jan-Apr. | |
| 3195529 | Result | 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 |
| 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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|
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |