Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection

Study Overview
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Brief Summary
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A controlled clinical trial was conducted at eight participating centers between January 1, 1988, and March 31, 1991. Patients were randomly assigned to an intravenous immune globulin group or a control group. There were two phases to the study (see below). During phase 1 the control infants received infusions of placebo. During phase 2 the control infants received no infusion therapy.

Detailed Description
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Although survival rates for very-low-birth-weight infants (≤ 1.5 kg) continue to increase, nosocomial infections remain a major cause of morbidity and mortality. Prolonged hospitalization with exposure to resistant organisms and multiple invasive procedures, in the presence of immunologic immaturity, renders these infants vulnerable to hospital-acquired infections. Prior studies testing the ability of intravenous immune globulin to prevent nosocomial infections in premature infants have varied in design and sample size. Despite differences in the rates of observed infection, immune globulin preparations, doses, and infusion intervals, a meta-analysis of published reports suggests that nosocomial infections may be diminished by the prophylactic infusion of IgG. The National Institute of Child Health and Human Development (NICHD) Neonatal Research Network therefore performed a prospective, multicenter, randomized trial at eight participating centers to test the hypothesis that the intravenous administration of immune globulin to infants with birth weights between 501 and 1500g would reduce the incidence of nosocomial infections. Patients were randomly assigned to an intravenous immune globulin group or a control group. During phase 1 the control infants received infusions of placebo. During phase 2 the control infants received no infusion therapy.

Official Title
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Randomized Clinical Trial of Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection in Very-Low-Birth-Weight Infants

Conditions
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Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Sepsis

Intervention / Treatment
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* Drug: IVIG
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All neonates with birth weights of 501 to 1500 g Exclusion Criteria: More than 72 hours old One of three or more fetuses from a multiple pregnancy Had infections associated with toxoplasma, rubella, cytomegalovirus, and herpes simplex viruses (the TORCH complex) Has a major congenital malformation, an identifiable syndrome, or a chromosomal abnormality Were considered nonviable Parental consent could not be obtained

Ages Eligible for Study
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Maximum Age: 72 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immune globulin<br>Lyophilized human immune globulin product | Drug: IVIG<br>* The infants received their first dose of study drug within 24 hours of randomization.<br>* Other names: Sandoglobulin;|
| Placebo Comparator: Albumin solution<br> | Drug: Placebo<br>* An equal volume of 5 percent albumin solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of nosocomial infection | Including septicemia, meningitis, or urinary tract infection | 120 days of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 120 Days of life | 
| Morbidity | Duration of ventilator support, frequency of bronchopulmonary dysplasia, and duration of hospitalization | 120 days of life | 
| Local infections |  | 120 days of life | 
| Necrotizing enterocolitis |  | 120 days of life | 
| Specific complications of immune globulin or placebo infusion |  | 120 days of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Prematurity, Septicemia, Meningitis, Urinary tract infection, Immune globulin