Safety of intravenous immunoglobulin infusion in neonates at risk for sepsis.
Intravenous immunoglobulin (Gammagard 5%), 500 mg/kg, was given over 3 hours to 10 acutely ill infants with proven or suspected sepsis (treatment group) and 10 clinically stable preterm infants less than 1750 gm birthweight as prophylaxis for sepsis (prevention group). No differences were found in heart rate, respiratory rate, mean arterial blood pressure, or urine output in either group during or following the infusion compared with preinfusion values, except for a small but significant decrease in heart rate postinfusion in the prevention group. Likewise, serum glucose, sodium, serum glutamic oxaloacetic transaminase, and osmolality were unchanged 15 minutes and 6 hours following infusion. Urea nitrogen rose a small but significant amount in both groups. Hemoglobin concentration declined a small but significant amount 15 minutes postinfusion in the prevention group, but returned to baseline by 6 hours postinfusion. There were no changes in white blood cell count or platelet counts in either group. These data indicate that intravenous immunoglobulin in the dose given was associated with no adverse effects. Additional studies are warranted to evaluate the efficacy of these preparations in the treatment and prevention of neonatal septicemia.
Homan
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SE
Section of Neonatology, Children's Mercy Hospital, Kansas City, MO 64108.
Hall
R T
RT
Hall
S L
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Meade
V M
VM
Kurth
C G
CG
D000914:Antibodies, Viral / Q000008:administration & dosage* / Q000009:adverse effects; D004341:Drug Evaluation; D006801:Humans; D007116:Immunization, Passive / Q000009:adverse effects; D007136:Immunoglobulins / Q000008:administration & dosage* / Q000009:adverse effects; D016756:Immunoglobulins, Intravenous; D007231:Infant, Newborn; D007262:Infusions, Intravenous; D010865:Pilot Projects; D018805:Sepsis / Q000188:drug therapy* / Q000517:prevention & control
D000914:Antibodies, Viral; D007136:Immunoglobulins; D016756:Immunoglobulins, Intravenous