Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01203345
First received: September 15, 2010
Last updated: January 9, 2011
Last verified: September 2010

September 15, 2010
January 9, 2011
January 1988
March 1991   (final data collection date for primary outcome measure)
Incidence of nosocomial infection [ Time Frame: 120 days of life ] [ Designated as safety issue: Yes ]
Including septicemia, meningitis, or urinary tract infection
Same as current
Complete list of historical versions of study NCT01203345 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection
Randomized Clinical Trial of Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection in Very-Low-Birth-Weight Infants

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Infant, Newborn
  • Infant, Low Birth Weight
  • Infant, Small for Gestational Age
  • Infant, Premature
  • Sepsis
  • Drug: IVIG
    The infants received their first dose of study drug within 24 hours of randomization.
    Other Name: Sandoglobulin
  • Drug: Placebo
    An equal volume of 5 percent albumin solution
  • Active Comparator: Immune globulin
    Lyophilized human immune globulin product
    Intervention: Drug: IVIG
  • Placebo Comparator: Albumin solution
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2416
March 1991
March 1991   (final data collection date for primary outcome measure)

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
Both
up to 72 Hours
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01203345
NICHD-NRN-0002, U10HD021364, U10HD021415, U01HD019897, U10HD021385, U10HD021397, U10HD021373
Yes
Avroy A. Fanaroff, Lead Principal Investigator, Case Western Reserve University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP