Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Sepsis

In brief

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.

Key facts

Study ID

NCT01203345

Run by

NICHD Neonatal Research Network

People needed

2416

Starts

1988-01-01

Expected to finish

1991-03-01

Last updated by the study team

2019-03-22

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All neonates with birth weights of 501 to 1500 g

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• George Washington University — Washington D.C., District of Columbia, United States
• University of Miami — Miami, Florida, United States
• Wayne State University — Detroit, Michigan, United States
• Case Western Reserve University, Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• University of Tennessee — Memphis, Tennessee, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
• University of Vermont — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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