Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Sepsis |
Drug: IVIG Drug: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Randomized Clinical Trial of Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection in Very-Low-Birth-Weight Infants |
- Incidence of nosocomial infection [ Time Frame: 120 days of life ] [ Designated as safety issue: Yes ]Including septicemia, meningitis, or urinary tract infection
- Death [ Time Frame: 120 Days of life ] [ Designated as safety issue: Yes ]
- Morbidity [ Time Frame: 120 days of life ] [ Designated as safety issue: Yes ]Duration of ventilator support, frequency of bronchopulmonary dysplasia, and duration of hospitalization
- Local infections [ Time Frame: 120 days of life ] [ Designated as safety issue: Yes ]
- Necrotizing enterocolitis [ Time Frame: 120 days of life ] [ Designated as safety issue: Yes ]
- Specific complications of immune globulin or placebo infusion [ Time Frame: 120 days of life ] [ Designated as safety issue: Yes ]
| Enrollment: | 2416 |
| Study Start Date: | January 1988 |
| Study Completion Date: | March 1991 |
| Primary Completion Date: | March 1991 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Immune globulin
Lyophilized human immune globulin product
|
Drug: IVIG
The infants received their first dose of study drug within 24 hours of randomization.
Other Name: Sandoglobulin
|
| Placebo Comparator: Albumin solution |
Drug: Placebo
An equal volume of 5 percent albumin solution
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | up to 72 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35233 | |
| United States, District of Columbia | |
| George Washington University | |
| Washington, District of Columbia, United States, 20052 | |
| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, Ohio | |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Tennessee | |
| University of Tennessee | |
| Memphis, Tennessee, United States, 38163 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75235 | |
| United States, Vermont | |
| University of Vermont | |
| Burlington, Vermont, United States, 05405 | |
| Study Director: | Avroy A. Fanaroff, MD | Case Western Reserve University |
| Principal Investigator: | Sheldon B. Korones, MD | University of Tennessee |
| Principal Investigator: | Elizabeth C. Wright, PhD | George Washington University |
| Principal Investigator: | Ronald L. Poland, MD | Wayne State University |
| Principal Investigator: | Charles R. Bauer, MD | University of Miami |
| Principal Investigator: | Jon E. Tyson, MD MPH | University of Texas |
| Principal Investigator: | Joseph B. Philips, MD | University of Alabama at Birmingham |
| Principal Investigator: | Jerold F. Lucey, MD | University of Vermont, Burlington |
More Information
Additional Information:
Publications:
| Responsible Party: | Avroy A. Fanaroff, Lead Principal Investigator, Case Western Reserve University |
| ClinicalTrials.gov Identifier: | NCT01203345 History of Changes |
| Other Study ID Numbers: | NICHD-NRN-0002, U10HD021364, U10HD021415, U01HD019897, U10HD021385, U10HD021397, U10HD021373 |
| Study First Received: | September 15, 2010 |
| Last Updated: | January 9, 2011 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
NICHD Neonatal Research Network Extremely Low Birth Weight (ELBW) Prematurity Septicemia |
Meningitis Urinary tract infection Immune globulin |
Additional relevant MeSH terms:
|
Birth Weight Sepsis Body Weight Signs and Symptoms Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
Antibodies Immunoglobulins Immunoglobulins, Intravenous Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 13, 2013