Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection

NICHD Neonatal Research Network

Status and phase

Completed

Phase 3

Phase 2

Conditions

Infant, Low Birth Weight

Infant, Newborn

Infant, Small for Gestational Age

Infant, Premature

Sepsis

Treatments

Drug: IVIG

Drug: Placebo

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT01203345

U10HD021373 (U.S. NIH Grant/Contract)

U10HD021415 (U.S. NIH Grant/Contract)

NICHD-NRN-0002

U01HD019897 (U.S. NIH Grant/Contract)

U10HD021397 (U.S. NIH Grant/Contract)

U10HD021364 (U.S. NIH Grant/Contract)

U10HD021385 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,416 patients

Sex

All

Ages

Under 72 hours old

Volunteers

Accepts Healthy Volunteers

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