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Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection (IVIG)

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ClinicalTrials.gov Identifier: NCT01203345
Recruitment Status : Completed
First Posted : September 16, 2010
Last Update Posted : March 22, 2019
Information provided by:
NICHD Neonatal Research Network

Brief 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.

Condition or disease Intervention/treatment Phase
Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Sepsis Drug: IVIG Drug: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2416 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 1988
Actual Primary Completion Date : March 1991
Actual Study Completion Date : March 1991

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Incidence of nosocomial infection [ Time Frame: 120 days of life ]
    Including septicemia, meningitis, or urinary tract infection

Secondary Outcome Measures :
  1. Death [ Time Frame: 120 Days of life ]
  2. Morbidity [ Time Frame: 120 days of life ]
    Duration of ventilator support, frequency of bronchopulmonary dysplasia, and duration of hospitalization

  3. Local infections [ Time Frame: 120 days of life ]
  4. Necrotizing enterocolitis [ Time Frame: 120 days of life ]
  5. Specific complications of immune globulin or placebo infusion [ Time Frame: 120 days of life ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01203345

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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
Sponsors and Collaborators
NICHD Neonatal Research Network
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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
Additional Information:
Publications of Results:
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Responsible Party: Avroy A. Fanaroff, Lead Principal Investigator, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01203345    
Other Study ID Numbers: NICHD-NRN-0002
U10HD021364 ( U.S. NIH Grant/Contract )
U10HD021415 ( U.S. NIH Grant/Contract )
U01HD019897 ( U.S. NIH Grant/Contract )
U10HD021385 ( U.S. NIH Grant/Contract )
U10HD021397 ( U.S. NIH Grant/Contract )
U10HD021373 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: September 2010
Keywords provided by NICHD Neonatal Research Network:
NICHD Neonatal Research Network
Extremely Low Birth Weight (ELBW)
Urinary tract infection
Immune globulin
Additional relevant MeSH terms:
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Birth Weight
Body Weight
Immunoglobulins, Intravenous
Immunologic Factors
Physiological Effects of Drugs