Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection
Information source: NICHD Neonatal Research Network
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature; Sepsis
Intervention: IVIG (Drug); Placebo (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: NICHD Neonatal Research Network Official(s) and/or principal investigator(s): Avroy A. Fanaroff, MD, Study Director, Affiliation: Case Western Reserve University Sheldon B. Korones, MD, Principal Investigator, Affiliation: University of Tennessee Elizabeth C. Wright, PhD, Principal Investigator, Affiliation: George Washington University Ronald L. Poland, MD, Principal Investigator, Affiliation: Wayne State University Charles R. Bauer, MD, Principal Investigator, Affiliation: University of Miami Jon E. Tyson, MD MPH, Principal Investigator, Affiliation: University of Texas Joseph B. Philips, MD, Principal Investigator, Affiliation: University of Alabama at Birmingham Jerold F. Lucey, MD, Principal Investigator, Affiliation: University of Vermont, Burlington
Summary
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.
Clinical Details
Official title: Randomized Clinical Trial of Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection in Very-Low-Birth-Weight Infants
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Incidence of nosocomial infection
Secondary outcome: DeathMorbidity Local infections Necrotizing enterocolitis Specific complications of immune globulin or placebo infusion
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
Minimum age: N/A.
Maximum age: 72 Hours.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University of Alabama at Birmingham, Birmingham, Alabama 35233, United States
George Washington University, Washington, District of Columbia 20052, United States
University of Miami, Miami, Florida 33136, United States
Wayne State University, Detroit, Michigan 48201, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland, Ohio 44106, United States
University of Tennessee, Memphis, Tennessee 38163, United States
University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75235, United States
University of Vermont, Burlington, Vermont 05405, United States
Additional Information
NICHD Neonatal Research Network
Starting date: January 1988
Last updated: June 3, 2015
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