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Completed Phase 2Phase 3 Interventional Accepts healthy volunteers

Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection

ClinicalTrials.gov ID: NCT01203345

Public ClinicalTrials.gov record NCT01203345. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 4:52 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Randomized Clinical Trial of Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection in Very-Low-Birth-Weight Infants

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01203345
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Enrollment
2,416 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Up to 72 Hours
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 1988 (Type not available)
Primary completion
Mar 1991 (Actual)
Completion
Mar 1991 (Actual)
Last update posted
Mar 22, 2019

1988 – 1991

United States locations

U.S. sites
8
U.S. states
8
U.S. cities
8
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35233 —
George Washington University Washington D.C. District of Columbia 20052 —
University of Miami Miami Florida 33136 —
Wayne State University Detroit Michigan 48201 —
Case Western Reserve University, Rainbow Babies and Children's Hospital Cleveland Ohio 44106 —
University of Tennessee Memphis Tennessee 38163 —
University of Texas Southwestern Medical Center at Dallas Dallas Texas 75235 —
University of Vermont Burlington Vermont 05405 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01203345, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 22, 2019 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01203345 live on ClinicalTrials.gov.

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