Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01203345 · ClinicalTrials.gov registry record · Phase 2

Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection

A Phase 2 study of Sepsis and Infant, Newborn, sponsored by NICHD Neonatal Research Network.

Completed
Registry status
Phase 2
Development phase
2,416
Enrollment target
8
Study locations

NCT01203345 is a Phase 2 study of Sepsis and Infant, Newborn that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 2,416 participants, below the 6,538-participant average among 90 other Sepsis trials with a reported enrollment target (63% lower). The trial reports 8 study locations across 8 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01203345, a Phase 2 study of Sepsis and Infant, Newborn, has completed, sponsored by NICHD Neonatal Research Network.

COMPLETED
Registry status
Phase 2
Development phase
2,416 participants
Enrollment target
8
Study locations

Study 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 Studied

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

Interventions

  • DRUG Placebo
  • DRUG IVIG

Study Locations (8)

Alabama

  • University of Alabama at Birmingham - Birmingham

District of Columbia

  • George Washington University - Washington D.C.

Florida

  • University of Miami - Miami

Michigan

  • Wayne State University - Detroit

Ohio

  • Case Western Reserve University, Rainbow Babies and Children's Hospital - Cleveland

Tennessee

  • University of Tennessee - Memphis

Texas

  • University of Texas Southwestern Medical Center at Dallas - Dallas

Vermont

  • University of Vermont - Burlington

Trial Details

FieldValue
Enrollment Target 2,416 participants
Start Date 1988-01
Est. Completion 1991-03
Phase Phase 2

Sponsor

NICHD Neonatal Research Network

61 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01203345

The ClinicalTrials.gov registry entry for NCT01203345 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 2,416 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,538-participant average among 90 other Sepsis trials with a reported enrollment target (63% lower). The listed sponsor is NICHD Neonatal Research Network, which has 61 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Sepsis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01203345 reports 8 study locations spanning 8 distinct geographic areas - top geographies include Alabama, District of Columbia, Florida.

Frequently Asked Questions

What is clinical trial NCT01203345 about?

NCT01203345 is a clinical study titled "Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection". 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 receive...

What is the current status of trial NCT01203345?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 2,416 participants. The study started on 1988-01. Estimated completion is 1991-03.

What conditions does trial NCT01203345 study?

This clinical trial studies the following conditions: Sepsis, Infant, Newborn, Infant, Premature, Infant, Small for Gestational Age, Infant, Low Birth Weight.

What interventions are being tested in trial NCT01203345?

The interventions under investigation include: Placebo (DRUG), IVIG (DRUG).

Who is sponsoring clinical trial NCT01203345?

This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01203345 being conducted?

This trial has 8 study locations across Alabama, District of Columbia, Florida, Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Sepsis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Sepsis

All registered trials for this condition

Infant, Newborn

All registered trials for this condition

Alabama

All trials with a study site in Alabama

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.