Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection

NCT01203345 | Completed Phase 2 DMC

• 7 other identifiers: NICHD-NRN-0002U10HD021364U10HD021415U01HD019897U10HD021385U10HD021397U10HD021373
• Study Type: interventional
• Target: 2,416
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

NICHD Neonatal Research Network; Extremely Low Birth Weight (ELBW); Prematurity; Septicemia; Meningitis; Urinary tract infection; Immune globulin

Outcome Measures

Primary Outcomes (1)

• Incidence of nosocomial infection

  Including septicemia, meningitis, or urinary tract infection

  120 days of life

Secondary Outcomes (5)

• Death

  120 Days of life

• Morbidity

  120 days of life

• Local infections

  120 days of life

• Necrotizing enterocolitis

  120 days of life

• Specific complications of immune globulin or placebo infusion

  120 days of life

Study Arms (2)

Immune globulin

ACTIVE COMPARATOR

Lyophilized human immune globulin product

Drug: IVIG

Albumin solution

PLACEBO COMPARATOR

Drug: Placebo

Interventions

IVIG DRUG

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

Also known as: Sandoglobulin

Immune globulin

Placebo DRUG

An equal volume of 5 percent albumin solution

Albumin solution

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• NICHD Neonatal Research Network: lead

Study Sites (8)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

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

Cleveland, Ohio, 44106, United States

Location

University of Tennessee

Memphis, Tennessee, 38163, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

University of Vermont

Burlington, Vermont, 05405, United States

Location

Related Publications (2)

• Fanaroff AA, Korones SB, Wright LL, Verter J, Poland RL, Bauer CR, Tyson JE, Philips JB 3rd, Edwards W, Lucey JF, Catz CS, Shankaran S, Oh W. Incidence, presenting features, risk factors and significance of late onset septicemia in very low birth weight infants. The National Institute of Child Health and Human Development Neonatal Research Network. Pediatr Infect Dis J. 1998 Jul;17(7):593-8. doi: 10.1097/00006454-199807000-00004.

  PMID: 9686724 RESULT

• Fanaroff AA, Korones SB, Wright LL, Wright EC, Poland RL, Bauer CB, Tyson JE, Philips JB 3rd, Edwards W, Lucey JF, et al. A controlled trial of intravenous immune globulin to reduce nosocomial infections in very-low-birth-weight infants. National Institute of Child Health and Human Development Neonatal Research Network. N Engl J Med. 1994 Apr 21;330(16):1107-13. doi: 10.1056/NEJM199404213301602.

  PMID: 8133853 RESULT

Related Links

• NICHD Neonatal Research Network

MeSH Terms

Conditions

Premature Birth; Sepsis; Meningitis; Urinary Tract Infections

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuroinflammatory Diseases; Nervous System Diseases; Urologic Diseases; Female Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Avroy A. Fanaroff, MD

  Case Western Reserve University

  STUDY DIRECTOR

• Sheldon B. Korones, MD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

• Elizabeth C. Wright, PhD

  George Washington University

  PRINCIPAL INVESTIGATOR

• Ronald L. Poland, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

• Charles R. Bauer, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Jon E. Tyson, MD MPH

  University of Texas

  PRINCIPAL INVESTIGATOR

• Joseph B. Philips, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Jerold F. Lucey, MD

  University of Vermont, Burlington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 16, 2010
• Study Start: January 1, 1988
• Primary Completion: March 1, 1991
• Study Completion: March 1, 1991
• Last Updated: March 22, 2019

Record last verified: 2010-09

Locations

US (8)