Infant, Low Birth Weight, Infant, Newborn, Infant, Premature, Infant, Small for Gestational Age, Sepsis
Conditions
Keywords
NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Prematurity, Septicemia, Meningitis, Urinary tract infection, Immune globulin
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.
Interventions
DRUGIVIG
The infants received their first dose of study drug within 24 hours of randomization.
DRUGPlacebo
An equal volume of 5 percent albumin solution
Sponsors
NICHD Neonatal Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 72 Hours
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of nosocomial infection | 120 days of life | Including septicemia, meningitis, or urinary tract infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | 120 Days of life | — |
| Morbidity | 120 days of life | Duration of ventilator support, frequency of bronchopulmonary dysplasia, and duration of hospitalization |
| Local infections | 120 days of life | — |
| Necrotizing enterocolitis | 120 days of life | — |
| Specific complications of immune globulin or placebo infusion | 120 days of life | — |
Countries
United States
Outcome results
None listed