Efficacy and pharmacokinetics of intravenous immune globulin administration to high-risk neonates
J. Kinney, L. Mundorf, C. Gleason, C. Lee, T. Townsend, R. Thibault, A. Nussbaum, H. Abby and R. Yolken
Department of Pediatrics, Johns Hopkins School of Medicine, Baltimore, Md.
OBJECTIVE--To determine whether intravenous immune globulin (IVIG)
administration modifies the incidence of infections in high-risk neonates.
DESIGN--Randomized, double-blind study. SETTING--Neonatal intensive care
unit at a tertiary care center. PARTICIPANTS. A total of 170 infants were
enrolled, 82 of whom received IVIG and 88 of whom received the placebo
preparation. Infants were stratified by birth weight into one of three
groups (category 1, those weighing less than 1000 g; category 2, those
weighing between 1000 and 1500 g; and category 3, those weighing more than
1500 g). INTERVENTIONS--Intravenous immune globulin (750 mg/kg of body
weight), or albumin placebo was administered within 72 hours of admission
to the tertiary care center and every 14 days thereafter until discharge
from the neonatal intensive care unit or age 3 months. Serum IgG levels
were measured and data collected relating to the incidence of systemic and
localized infections and to the course of hospitalization. MEASUREMENTS AND
MAIN RESULTS--The administration of IVIG had no major side effects and
resulted in higher serum IgG levels in infants in all birth weight
categories compared with infants receiving the placebo. Systemic infections
developed in five IVIG-treated infants and five placebo-treated infants.
Administration of immunoglobulin had no significant effect on the rate of
localized infections or necrotizing enterocolitis. It also did not affect
hospital course of the infants as measured by length of hospitalization or
the number of days on assisted ventilation, supplemental oxygen, or
antibiotics was required. CONCLUSIONS--The general administration of IVIG
using this dosage regimen has limited effects on the clinical course of
infants in a neonatal intensive care unit.
