Inflammation Clinical Trial
Official title:
Efficacy of Prophylactic IgM-Enriched Immunoglobulin for the Management of Early-Onset Neonatal Sepsis in Very Low Birth Weight Preterm Neonates; A Randomized Controlled Trial
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.
Status | Not yet recruiting |
Enrollment | 70 |
Est. completion date | August 2020 |
Est. primary completion date | June 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 1 Hour |
Eligibility |
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Fakultas Kedokteran Universitas Indonesia |
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. Review. — View Citation
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. — View Citation
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 (ELBW) with sepsis: a retrospective cohort study. Minerva Pediatr. 2018 Feb 19. doi: 10.23736/S0026-4946.18.04850-8. [Epub ahead of print] — View Citation
Haque KN, Zaidi MH, Bahakim H. IgM-enriched intravenous immunoglobulin therapy in neonatal sepsis. Am J Dis Child. 1988 Dec;142(12):1293-6. — View Citation
Reith HB, Rauchschwalbe SK, Mittelkötter 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Early Mortality Rate | Neonates in the treatment group should have lower mortality rate in the first week of life | 1 week | |
Secondary | Positive blood culture | Neonates in the treatment group should have less number of positive blood culture than those in the place group | 1 week | |
Secondary | Duration of NICU stay | Neonates in the treatment group should be discharged earlier than those in the placebo group | Through study completion, an average of 3 months | |
Secondary | Quantitative CRP Levels | Neonates in the treatment group should have lower CRP levels than those in the placebo group | 1 week | |
Secondary | IT Ratio value | Neonates in the treatment group should have lower IT Ratio value than those in the placebo group | 1 week | |
Secondary | Leukocyte count | Neonates in the treatment group should have lower Leukocyte count than those in the placebo group | 1 week | |
Secondary | IgGAME (IgG, IgM, IgA, IgE) Levels | Neonates in the treatment group should have higher IgGAME levels than those in the placebo group | 1 week |
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