TY - JOUR
T1 - Role of intravenous immunoglobulin in prevention of late-onset infection in low-birth-weight neonates
AU - Neonatal IVIG Study Group
AU - Baker, Carol J.
AU - Rench, Marcia A.
AU - Noya, Francisco J.D.
AU - Garcia-Prats, Joseph A.
AU - Givner, Laurence B.
AU - Hall, Robert A.
AU - Melish, Marian E.
AU - Ramamurthy, Rajam
AU - Vasan, Ushanalini
N1 - Funding Information:
This work was supported in part by Hyland Therapeutics Division, Travenol Laboratories, Glendale, Cali fornia. *Laurence B. Givner (Winston-Salem, N.C.); Robert A. Hall (Kansas City, Mo.); Marian E. Melish (Honolulu, Hawaii); Rajam Ramamurthy (San Antonio, Tex.);and Ushanalini Vasan (Chicago, III.).
PY - 1990/5
Y1 - 1990/5
N2 - As a result of inadequate placental transport of maternal IgG, preterm neonates of <32 ' gestation, especially those with birth weights <1,500 g, are profoundly hypogammaglobulinemic at birth, a condition that worsens during the first several weeks of life. This hypogammaglobulinemia is believed to contribute to their high frequency of lateonset sepsis, with its accompanying morbidity and mortality. Animal studies suggest that human immunoglobulin prepared for intravenous use (IVIG) improves host defense against pathogens that cause neonatal infections, but studies of IVIG in human neonates have been inconclusive because of the small numbers of infants included, lack of suitable controls, use of clinical rather than strict microbiologic definition of sepsis, and performance only in a single hospital outside the United States. A double-blind, randomized, placebo-controlled multicenter trial in the United States is in progress to determine the efficacy of IVIG in the prevention of late-onset infections in infants with birth weights between 500 and 1,750 g. Infants are infused with 500 mg of IVIG/kg or albumin-saline placebo at 3–7 days of age, 7 days later, and every 14 days for five doses. Efficacy parameters include mortality, number of proved infectious episodes (bacterial, fungal, or viral), and infection-related morbidity. Definitive guidelines for the possible use of prophylactic IVIG in low-birth-weight neonates should result from this evaluation of 500 to 700 infants in the United States.
AB - As a result of inadequate placental transport of maternal IgG, preterm neonates of <32 ' gestation, especially those with birth weights <1,500 g, are profoundly hypogammaglobulinemic at birth, a condition that worsens during the first several weeks of life. This hypogammaglobulinemia is believed to contribute to their high frequency of lateonset sepsis, with its accompanying morbidity and mortality. Animal studies suggest that human immunoglobulin prepared for intravenous use (IVIG) improves host defense against pathogens that cause neonatal infections, but studies of IVIG in human neonates have been inconclusive because of the small numbers of infants included, lack of suitable controls, use of clinical rather than strict microbiologic definition of sepsis, and performance only in a single hospital outside the United States. A double-blind, randomized, placebo-controlled multicenter trial in the United States is in progress to determine the efficacy of IVIG in the prevention of late-onset infections in infants with birth weights between 500 and 1,750 g. Infants are infused with 500 mg of IVIG/kg or albumin-saline placebo at 3–7 days of age, 7 days later, and every 14 days for five doses. Efficacy parameters include mortality, number of proved infectious episodes (bacterial, fungal, or viral), and infection-related morbidity. Definitive guidelines for the possible use of prophylactic IVIG in low-birth-weight neonates should result from this evaluation of 500 to 700 infants in the United States.
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U2 - 10.1093/clinids/12.Supplement_4.S463
DO - 10.1093/clinids/12.Supplement_4.S463
M3 - Article
C2 - 2114036
AN - SCOPUS:0025375181
VL - 12
SP - S463-S469
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
SN - 1058-4838
ER -