November 1991

Efficacy and Pharmacokinetics of Intravenous Immune Globulin Administration to High-Risk Neonates

Author Affiliations

From the Eudowood Division of Infectious Diseases, Department of Pediatrics (Drs Kinney, Townsend, and Yolken and Ms Mundorf), Division of Neonatology, Department of Pediatrics (Dr Gleason), and the Department of Radiology (Dr Nussbaum), The Johns Hopkins School of Medicine; Department of Pharmacy Services, The Johns Hopkins Hospital (Dr Lee and Ms Thibault); and the Department of Biostatistics, The Johns Hopkins School of Hygiene and Public Health, Baltimore, Md (Dr Abby). Dr Townsend is now with the Divisions of Neonatology and Infectious Diseases, The Children's Mercy Hospital, University of Missouri, Kansas City School of Medicine.

Am J Dis Child. 1991;145(11):1233-1238. doi:10.1001/archpedi.1991.02160110025013

• 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.(AJDC. 1991;145:1233-1238)