Clinical trialNCT01203345CompletedPhase 2/PHASE3Interventional

Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection

SponsorNICHD Neonatal Research NetworkEnrollment2,416Infant, Low Birth WeightInfant, NewbornInfant, PrematureInfant, Small for Gestational AgeSepsis

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Avroy A. Fanaroff, MD
Case Western Reserve University
Study Director
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Charles R. Bauer, MD
University of Miami
Principal Investigator
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Elizabeth C. Wright, PhD
George Washington University
Principal Investigator
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Jerold F. Lucey, MD
University of Vermont, Burlington
Principal Investigator
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Jon E. Tyson, MD MPH
University of Texas
Principal Investigator
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Joseph B. Philips, MD
University of Alabama at Birmingham
Principal Investigator
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Ronald L. Poland, MD
Wayne State University
Principal Investigator
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Sheldon B. Korones, MD
University of Tennessee
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

IVIG →Placebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Jan 1988
Primary completion: 31 Mar 1991
Completion: 31 Mar 1991
Last update posted: 22 Mar 2019
Registered enrollment: 2,416
Registry id: NCT01203345

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.