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
  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

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Incidence of nosocomial infection [ Time Frame: 120 days of life ] [ Designated as safety issue: Yes ]
    Including septicemia, meningitis, or urinary tract infection


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203345

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
Sponsors and Collaborators
Investigators
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 August 28, 2014