Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection

Sepsis Clinical Trial

— IVIG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203345
• Other study ID #: NICHD-NRN-0002
• Secondary ID: U10HD021364U10HD
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 1988
• Est. completion date: March 1991

Study information

• Verified date: September 2010
• Source: NICHD Neonatal Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2416
• Est. completion date: March 1991
• Est. primary completion date: March 1991
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 72 Hours

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• IVIG
The infants received their first dose of study drug within 24 hours of randomization.
• Placebo
An equal volume of 5 percent albumin solution

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Vermont	Burlington	Vermont
United States	Case Western Reserve University, Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	Wayne State University	Detroit	Michigan
United States	University of Tennessee	Memphis	Tennessee
United States	University of Miami	Miami	Florida
United States	George Washington University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
NICHD Neonatal Research Network

Country where clinical trial is conducted

United States, 

References & 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 i — View Citation

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 Institut — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of nosocomial infection	Including septicemia, meningitis, or urinary tract infection	120 days of life
Secondary	Death		120 Days of life
Secondary	Morbidity	Duration of ventilator support, frequency of bronchopulmonary dysplasia, and duration of hospitalization	120 days of life
Secondary	Local infections		120 days of life
Secondary	Necrotizing enterocolitis		120 days of life
Secondary	Specific complications of immune globulin or placebo infusion		120 days of life

External Links

•   NICHD Neonatal Research Network