Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection

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.

Conditions

• Infant, Newborn
• Infant, Low Birth Weight
• Infant, Small for Gestational Age
• Infant, Premature
• Sepsis

Interventions

DRUG

IVIG

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

DRUG

Placebo

An equal volume of 5 percent albumin solution

Sponsors & Collaborators

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Avroy A. Fanaroff, MD · Case Western Reserve University

• Sheldon B. Korones, MD · University of Tennessee

• Elizabeth C. Wright, PhD · George Washington University

• Ronald L. Poland, MD · Wayne State University

• Charles R. Bauer, MD · University of Miami

• Jon E. Tyson, MD MPH · University of Texas

• Joseph B. Philips, MD · University of Alabama at Birmingham

• Jerold F. Lucey, MD · University of Vermont, Burlington

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Max Age

72 Hours

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

1988-01-31

Primary Completion

1991-03-31

Completion

1991-03-31

Countries

• United States

Study Locations