DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection

Information source: NICHD Neonatal Research Network
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature; Sepsis

Intervention: IVIG (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: NICHD Neonatal Research Network

Official(s) and/or principal investigator(s):
Avroy A. Fanaroff, MD, Study Director, Affiliation: Case Western Reserve University
Sheldon B. Korones, MD, Principal Investigator, Affiliation: University of Tennessee
Elizabeth C. Wright, PhD, Principal Investigator, Affiliation: George Washington University
Ronald L. Poland, MD, Principal Investigator, Affiliation: Wayne State University
Charles R. Bauer, MD, Principal Investigator, Affiliation: University of Miami
Jon E. Tyson, MD MPH, Principal Investigator, Affiliation: University of Texas
Joseph B. Philips, MD, Principal Investigator, Affiliation: University of Alabama at Birmingham
Jerold F. Lucey, MD, Principal Investigator, Affiliation: University of Vermont, Burlington

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Incidence of nosocomial infection

Secondary outcome:

Death

Morbidity

Local infections

Necrotizing enterocolitis

Specific complications of immune globulin or placebo infusion

Detailed description: Although survival rates for very-low-birth-weight infants (≤ 1. 5 kg) continue to increase, nosocomial infections remain a major cause of morbidity and mortality. Prolonged hospitalization with exposure to resistant organisms and multiple invasive procedures, in the presence of immunologic immaturity, renders these infants vulnerable to hospital-acquired infections. Prior studies testing the ability of intravenous immune globulin to prevent nosocomial infections in premature infants have varied in design and sample size. Despite differences in the rates of observed infection, immune globulin preparations, doses, and infusion intervals, a meta-analysis of published reports suggests that nosocomial infections may be diminished by the prophylactic infusion of IgG. The National Institute of Child Health and Human Development (NICHD) Neonatal Research Network therefore performed a prospective, multicenter, randomized trial at eight participating centers to test the hypothesis that the intravenous administration of immune globulin to infants with birth weights between 501 and 1500g would reduce the incidence of nosocomial infections. Patients were randomly assigned to an intravenous immune globulin group or a control group. During phase 1 the control infants received infusions of placebo. During phase 2 the control infants received no infusion therapy.

Eligibility

Minimum age: N/A. Maximum age: 72 Hours. Gender(s): Both.

Criteria:

Inclusion Criteria:

- All neonates with birth weights of 501 to 1500 g

Exclusion Criteria:

- 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

Locations and Contacts

University of Alabama at Birmingham, Birmingham, Alabama 35233, United States

George Washington University, Washington, District of Columbia 20052, United States

University of Miami, Miami, Florida 33136, United States

Wayne State University, Detroit, Michigan 48201, United States

Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland, Ohio 44106, United States

University of Tennessee, Memphis, Tennessee 38163, United States

University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75235, United States

University of Vermont, Burlington, Vermont 05405, United States

Additional Information

NICHD Neonatal Research Network

Starting date: January 1988
Last updated: June 3, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017