Clinical trial NCT01203345: Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection
Official title: Randomized Clinical Trial of Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection in Very-Low-Birth-Weight Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
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
Lead sponsor: NICHD Neonatal Research Network
Sponsor class: NETWORK
First posted: 2010-09-16
Enrollment: 2416
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Incidence of nosocomial infection
timeFrame: 120 days of life
Secondary outcomes:
measure: Death
timeFrame: 120 Days of life
measure: Morbidity
timeFrame: 120 days of life
measure: Local infections
timeFrame: 120 days of life
measure: Necrotizing enterocolitis
timeFrame: 120 days of life
measure: Specific complications of immune globulin or placebo infusion
timeFrame: 120 days of life
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Cleveland
country: United States
facility: Case Western Reserve University, Rainbow Babies and Children's Hospital
state: Ohio
city: Memphis
country: United States
facility: University of Tennessee
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: Case Western Reserve University
name: Avroy A. Fanaroff, MD
role: STUDY_DIRECTOR
affiliation: University of Tennessee
name: Sheldon B. Korones, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: George Washington University
name: Elizabeth C. Wright, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Ronald L. Poland, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Charles R. Bauer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas
name: Jon E. Tyson, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Joseph B. Philips, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vermont, Burlington
name: Jerold F. Lucey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 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.