Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection

• Status: Completed
• Trial end date: 1991-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NICHD Neonatal Research Network
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

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