A controlled trial of intravenous immune globulin to reduce nosocomial infections in very-low-birth-weight infants

Avroy A. Fanaroff, Sheldon B. Korones, Linda L. Wright, Elizabeth C. Wright, Ronald L. Poland, Charles R Bauer, Jon E. Tyson, Joseph B. Philips, William Edwards, Jerold F. Lucey, Charlotte S. Catz, Seetha Shankaran, William Oh

Research output: Contribution to journalArticle

155 Citations (Scopus)

Abstract

Background. Nosocomial infections are a major cause of morbidity and mortality in premature infants. As a rule, their low serum gamma globulin levels at birth subsequently decline to hypogammaglobulinemic values; hence, prophylactic administration of intravenous immune globulin may reduce the rate of hospital-acquired infections. Methods. In this prospective, multicenter, two-phase controlled trial, 2416 infants were stratified according to birth weight (501 to 1000 g and 1001 to 1500 g) and randomly assigned to an intravenous immune globulin group (n = 1204) or a control group (n = 1212). Control infants were given placebo infusions during phase 1 of the study (n = 623) but were not given any infusions during phase 2 (n = 589). Infants weighing 501 to 1000 g at birth were given 900 mg of immune globulin per kilogram of body weight, and infants weighing 1001 to 1500 g at birth were given a dose of 700 mg per kilogram. The immune globulin infusions were repeated every 14 days until the infants weighed 1800 g, were transferred to another center, died, or were sent home from the hospital. Results. Nosocomial infections of the blood, meninges, or urinary tract occurred in 439 of the 2416 infants (18.2 percent): 208 (17.3 percent) in the immune globulin group and 231 (19.1 percent) in the control group (relative risk, 0.91; 95 percent confidence interval, 0.77 to 1.08). Septicemia occurred in 15.5 percent of the immune globulin recipients and 17.2 percent of the controls. During phase 1 the rate of nosocomial infections was 13.4 percent in the immune globulin group and 17.8 percent in the control group; the respective rates during phase 2 were 21.0 percent and 20.4 percent. The predominant organisms included gram-positive cocci (53.0 percent), gram- negative bacilli (22.4 percent), and candida species (16.0 percent). Adverse reactions were rarely observed during the infusions. Immune globulin therapy had no effect on respiratory distress syndrome, bronchopulmonary dysplasia, intracranial hemorrhage, the duration of hospitalization, or mortality. The incidence of necrotizing enterocolitis was 12.0 percent in the immune globulin group and 9.5 percent in the control group. Conclusions. Prophylactic use of intravenous immune globulin failed to reduce the incidence of hospital-acquired infections in very-low-birth-weight infants.

Original languageEnglish
Pages (from-to)1107-1113
Number of pages7
JournalNew England Journal of Medicine
Volume330
Issue number16
DOIs
StatePublished - Apr 29 1994

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Very Low Birth Weight Infant
Intravenous Immunoglobulins
Cross Infection
Immunoglobulins
Control Groups
Parturition
Serum Globulins
Meninges
Gram-Positive Cocci
Bronchopulmonary Dysplasia
Necrotizing Enterocolitis
Mortality
Intracranial Hemorrhages
gamma-Globulins
Incidence
Urinary Tract
Candida
Birth Weight
Premature Infants
Bacillus

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Fanaroff, A. A., Korones, S. B., Wright, L. L., Wright, E. C., Poland, R. L., Bauer, C. R., ... Oh, W. (1994). A controlled trial of intravenous immune globulin to reduce nosocomial infections in very-low-birth-weight infants. New England Journal of Medicine, 330(16), 1107-1113. https://doi.org/10.1056/NEJM199404213301602

A controlled trial of intravenous immune globulin to reduce nosocomial infections in very-low-birth-weight infants. / Fanaroff, Avroy A.; Korones, Sheldon B.; Wright, Linda L.; Wright, Elizabeth C.; Poland, Ronald L.; Bauer, Charles R; Tyson, Jon E.; Philips, Joseph B.; Edwards, William; Lucey, Jerold F.; Catz, Charlotte S.; Shankaran, Seetha; Oh, William.

In: New England Journal of Medicine, Vol. 330, No. 16, 29.04.1994, p. 1107-1113.

Research output: Contribution to journalArticle

Fanaroff, AA, Korones, SB, Wright, LL, Wright, EC, Poland, RL, Bauer, CR, Tyson, JE, Philips, JB, Edwards, W, Lucey, JF, Catz, CS, Shankaran, S & Oh, W 1994, 'A controlled trial of intravenous immune globulin to reduce nosocomial infections in very-low-birth-weight infants', New England Journal of Medicine, vol. 330, no. 16, pp. 1107-1113. https://doi.org/10.1056/NEJM199404213301602
Fanaroff, Avroy A. ; Korones, Sheldon B. ; Wright, Linda L. ; Wright, Elizabeth C. ; Poland, Ronald L. ; Bauer, Charles R ; Tyson, Jon E. ; Philips, Joseph B. ; Edwards, William ; Lucey, Jerold F. ; Catz, Charlotte S. ; Shankaran, Seetha ; Oh, William. / A controlled trial of intravenous immune globulin to reduce nosocomial infections in very-low-birth-weight infants. In: New England Journal of Medicine. 1994 ; Vol. 330, No. 16. pp. 1107-1113.
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abstract = "Background. Nosocomial infections are a major cause of morbidity and mortality in premature infants. As a rule, their low serum gamma globulin levels at birth subsequently decline to hypogammaglobulinemic values; hence, prophylactic administration of intravenous immune globulin may reduce the rate of hospital-acquired infections. Methods. In this prospective, multicenter, two-phase controlled trial, 2416 infants were stratified according to birth weight (501 to 1000 g and 1001 to 1500 g) and randomly assigned to an intravenous immune globulin group (n = 1204) or a control group (n = 1212). Control infants were given placebo infusions during phase 1 of the study (n = 623) but were not given any infusions during phase 2 (n = 589). Infants weighing 501 to 1000 g at birth were given 900 mg of immune globulin per kilogram of body weight, and infants weighing 1001 to 1500 g at birth were given a dose of 700 mg per kilogram. The immune globulin infusions were repeated every 14 days until the infants weighed 1800 g, were transferred to another center, died, or were sent home from the hospital. Results. Nosocomial infections of the blood, meninges, or urinary tract occurred in 439 of the 2416 infants (18.2 percent): 208 (17.3 percent) in the immune globulin group and 231 (19.1 percent) in the control group (relative risk, 0.91; 95 percent confidence interval, 0.77 to 1.08). Septicemia occurred in 15.5 percent of the immune globulin recipients and 17.2 percent of the controls. During phase 1 the rate of nosocomial infections was 13.4 percent in the immune globulin group and 17.8 percent in the control group; the respective rates during phase 2 were 21.0 percent and 20.4 percent. The predominant organisms included gram-positive cocci (53.0 percent), gram- negative bacilli (22.4 percent), and candida species (16.0 percent). Adverse reactions were rarely observed during the infusions. Immune globulin therapy had no effect on respiratory distress syndrome, bronchopulmonary dysplasia, intracranial hemorrhage, the duration of hospitalization, or mortality. The incidence of necrotizing enterocolitis was 12.0 percent in the immune globulin group and 9.5 percent in the control group. Conclusions. Prophylactic use of intravenous immune globulin failed to reduce the incidence of hospital-acquired infections in very-low-birth-weight infants.",
author = "Fanaroff, {Avroy A.} and Korones, {Sheldon B.} and Wright, {Linda L.} and Wright, {Elizabeth C.} and Poland, {Ronald L.} and Bauer, {Charles R} and Tyson, {Jon E.} and Philips, {Joseph B.} and William Edwards and Lucey, {Jerold F.} and Catz, {Charlotte S.} and Seetha Shankaran and William Oh",
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T1 - A controlled trial of intravenous immune globulin to reduce nosocomial infections in very-low-birth-weight infants

AU - Fanaroff, Avroy A.

AU - Korones, Sheldon B.

AU - Wright, Linda L.

AU - Wright, Elizabeth C.

AU - Poland, Ronald L.

AU - Bauer, Charles R

AU - Tyson, Jon E.

AU - Philips, Joseph B.

AU - Edwards, William

AU - Lucey, Jerold F.

AU - Catz, Charlotte S.

AU - Shankaran, Seetha

AU - Oh, William

PY - 1994/4/29

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N2 - Background. Nosocomial infections are a major cause of morbidity and mortality in premature infants. As a rule, their low serum gamma globulin levels at birth subsequently decline to hypogammaglobulinemic values; hence, prophylactic administration of intravenous immune globulin may reduce the rate of hospital-acquired infections. Methods. In this prospective, multicenter, two-phase controlled trial, 2416 infants were stratified according to birth weight (501 to 1000 g and 1001 to 1500 g) and randomly assigned to an intravenous immune globulin group (n = 1204) or a control group (n = 1212). Control infants were given placebo infusions during phase 1 of the study (n = 623) but were not given any infusions during phase 2 (n = 589). Infants weighing 501 to 1000 g at birth were given 900 mg of immune globulin per kilogram of body weight, and infants weighing 1001 to 1500 g at birth were given a dose of 700 mg per kilogram. The immune globulin infusions were repeated every 14 days until the infants weighed 1800 g, were transferred to another center, died, or were sent home from the hospital. Results. Nosocomial infections of the blood, meninges, or urinary tract occurred in 439 of the 2416 infants (18.2 percent): 208 (17.3 percent) in the immune globulin group and 231 (19.1 percent) in the control group (relative risk, 0.91; 95 percent confidence interval, 0.77 to 1.08). Septicemia occurred in 15.5 percent of the immune globulin recipients and 17.2 percent of the controls. During phase 1 the rate of nosocomial infections was 13.4 percent in the immune globulin group and 17.8 percent in the control group; the respective rates during phase 2 were 21.0 percent and 20.4 percent. The predominant organisms included gram-positive cocci (53.0 percent), gram- negative bacilli (22.4 percent), and candida species (16.0 percent). Adverse reactions were rarely observed during the infusions. Immune globulin therapy had no effect on respiratory distress syndrome, bronchopulmonary dysplasia, intracranial hemorrhage, the duration of hospitalization, or mortality. The incidence of necrotizing enterocolitis was 12.0 percent in the immune globulin group and 9.5 percent in the control group. Conclusions. Prophylactic use of intravenous immune globulin failed to reduce the incidence of hospital-acquired infections in very-low-birth-weight infants.

AB - Background. Nosocomial infections are a major cause of morbidity and mortality in premature infants. As a rule, their low serum gamma globulin levels at birth subsequently decline to hypogammaglobulinemic values; hence, prophylactic administration of intravenous immune globulin may reduce the rate of hospital-acquired infections. Methods. In this prospective, multicenter, two-phase controlled trial, 2416 infants were stratified according to birth weight (501 to 1000 g and 1001 to 1500 g) and randomly assigned to an intravenous immune globulin group (n = 1204) or a control group (n = 1212). Control infants were given placebo infusions during phase 1 of the study (n = 623) but were not given any infusions during phase 2 (n = 589). Infants weighing 501 to 1000 g at birth were given 900 mg of immune globulin per kilogram of body weight, and infants weighing 1001 to 1500 g at birth were given a dose of 700 mg per kilogram. The immune globulin infusions were repeated every 14 days until the infants weighed 1800 g, were transferred to another center, died, or were sent home from the hospital. Results. Nosocomial infections of the blood, meninges, or urinary tract occurred in 439 of the 2416 infants (18.2 percent): 208 (17.3 percent) in the immune globulin group and 231 (19.1 percent) in the control group (relative risk, 0.91; 95 percent confidence interval, 0.77 to 1.08). Septicemia occurred in 15.5 percent of the immune globulin recipients and 17.2 percent of the controls. During phase 1 the rate of nosocomial infections was 13.4 percent in the immune globulin group and 17.8 percent in the control group; the respective rates during phase 2 were 21.0 percent and 20.4 percent. The predominant organisms included gram-positive cocci (53.0 percent), gram- negative bacilli (22.4 percent), and candida species (16.0 percent). Adverse reactions were rarely observed during the infusions. Immune globulin therapy had no effect on respiratory distress syndrome, bronchopulmonary dysplasia, intracranial hemorrhage, the duration of hospitalization, or mortality. The incidence of necrotizing enterocolitis was 12.0 percent in the immune globulin group and 9.5 percent in the control group. Conclusions. Prophylactic use of intravenous immune globulin failed to reduce the incidence of hospital-acquired infections in very-low-birth-weight infants.

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