Role of intravenous immunoglobulins for prevention and treatment of neonatal sepsis in preterms (Synopsis)

Role of intravenous immunoglobulins for prevention and treatment of neonatal sepsis in preterms

Introduction / Background
The benefit of passive immunization by prophylactic administration of intravenous immune globulin (IVIG) for prevention of bacterial infections has been established for patients with primary agammaglobulinemia and with symptomatic human immunodeficiency virus infection. Routine administration of IVIG for other immunocompromised hosts has not consistently been shown to clearly decrease the incidence of bacterial infections. IVIG appears to have a role in sepsis as it neutralizes bacterial toxins, enhances opsonisation and chemotaxis and modulates cytokine release. Several studies were canducted to. demonstrate the efficacy of IVIG in the prevention and treatment of neonatal sepsis. Exogenous immune globulin given at birth to premature low birth weight newborns may be beneficial for prevention of early-onset sepsis after peripartum transmission of maternal vaginal flora in the setting of low maternal antibody levels and for late-onset and late, late-onset (occurring after 30 days from birth) nosocomial infections.
Objectives
The objective of this study is to determine whether therapy with intravenous immunoglobulin G (IVIG) would decrease mortality in neonatal sepsis.
Material and Methods
Hypothesis
IVIG significantly reduces mortality in preterms with sepsis.
Study Design : Experimental Study
Sample Size : 50 Neonates
Sampling Method : Convenient sampling
Duration of Study : 6 months
Inclusion Criteria
All neonates admitted to the neonatal intensive care unit meeting the diagnostic criteria for probable sepsis.
Exclusion Criteria
1. birth-weights of less than 1000 g2. Neonates with major congenital malformations
Data Collection Procedure
All neonates admitted to the neonatal intensive care units of Holy Family Hospital Rawalpindi meeting the diagnostic criteria for probable sepsis as defined above, after informed consent, will be enrolled in the study.
Neonates divided into group A will be given 1 g/kg of IVIG on three consecutive days (IVIG treated group) and neonates of group B will receive an equivalent amount of placebo i.e., 0.15% saline in 10% dextrose (non IVIG treated group). The rest of the treatment including antibiotics and supportive care was as per the treating physician’s decision. Both groups will be followed up till death or discharge and the duration of hospital stay. Outcome of the neonates as
Statistical Methods
Data analysis will be done by windows software SPSS 10. Beside descriptive statistics, two-by-two contingency tables will be constructed to determine the relationship between IVIG administration and outcome. Hypothesis testing will be performed using chi-square tests ( x2) and P values will be calculated. The magnitude of association between IVIG treatment and outcome was represented by the odds ratio (OR) and 95% confidence interval (CI).
Similar Preliminary Studies
Baker CJ, Edwards MS, Kasper DL. Role of antibody to native type III polysaccharide of group B Streptococcus in infant infection. Pediatrics 1981; 68:544-549.Buckley RH, Schiff RI. The use of intravenous immune globulin in immunodeficiency diseases. N Engl J Med 1991; 325:110-117.

Spector SA, Gelber RD, McGrath N. A controlled trial of intravenous immune globulin for the prevention of serious bacterial infections in children receiving zidovudine for advanced human immunodeficiency virus infection. N Engl J Med 1994; 331:1181-1187.

Lacy JB, Ohlson A. Administration of intravenous immunoglobulins for prophylaxis or treatment of infection in preterm infants: Meta-analysis. Arch Dis Child 1995; 72: F151-F155.








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