Trial | NCT01203345  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    2416
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.
Study Started
Jan 31
1988
Primary Completion
Mar 31
1991
Study Completion
Mar 31
1991
Last Update
Mar 22
2019

Drug IVIG

The infants received their first dose of study drug within 24 hours of randomization.

  • Other names: Sandoglobulin

Drug Placebo

An equal volume of 5 percent albumin solution

Immune globulin Active Comparator

Lyophilized human immune globulin product

Albumin solution Placebo Comparator

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
No Results Posted