FETAL AND NEONATAL MEDICINE
Randomized trial of granulocyte transfusions versus intravenous immune globulin therapy for neonatal neutropenia and sepsis Mitchell S. Cairo, MD, Carrie C. W o r c e s t e r , MD, Ralph W. Rucker, MD, S t e p h e n Hanten, MD, R a g n a r N. Amlie, MD, L e o n a r d Sender, MD, a n d David A. Hicks, MD From the Divisions of Hematology/Oncology and Neonatology, Children's Hospital of Orange County, Orange, California, and the Division of Research Immunology, Children's Hospital Los Angeles, Los Angeles, California We prospectively studied newborn infants with sepsis and neutropenia who were randomly selected to receive standard supportive care and either adjuvant g r a n u l o c y t e transfusions or intravenous immune globulin (IVIG) infusions; 21 infants received granulocyte transfusions and 14 r e c e i v e d IVIG infusions. Half of the patients were premature (gestational a g e __-90% were pure polymorphonuc|ear leukocytes as determined by microscopy. Granulocytes were transfused initially within 4 to 6 hours of diagnosis and were given twice a day during the first and second days of therapy; on
The Journal of Pediatrics February 1992
the third day of therapy granulocytes were administered once as a single infusion. This design was identical to our previous protocol and was intended to enhance both the quantitative and qualitative deficiencies of neonatal phagocytic immunity. Patients who were randomly selected to receive IVIG (Gamimune N) (5% immune globulin, pH 4.25, in 10% maltose solution) were given 1000 mg/kg intravenously during a 4- to 6-hour period each day during the first 3 days from the onset of neonatal sepsis. Similar supportive care was given to both groups of infants, including intravenous antibiotic therapy, fluid resuscitation, inotropic blood pressure support, and ventilator support for respiratory failure. Clinical and laboratory observations. The data were evaluated by a monitor unassociated with the clinical study. Demographic data collected on each patient included gestational age, postnatal age and weight at the start of the study, and presence or absence of prematurity. Severity of clinical illness was rated according to our previously established criteria 3 and was defined by one of the following: respiratory failure requiring an inspired oxygen concentration >--50% and ventilator support, acidosis with pH --
Randomized trial of granulocyte transfusions versus intravenous immune globulin therapy for neonatal neutropenia and sepsis Mitchell S. Cairo, MD, Carrie C. W o r c e s t e r , MD, Ralph W. Rucker, MD, S t e p h e n Hanten, MD, R a g n a r N. Amlie, MD, L e o n a r d Sender, MD, a n d David A. Hicks, MD From the Divisions of Hematology/Oncology and Neonatology, Children's Hospital of Orange County, Orange, California, and the Division of Research Immunology, Children's Hospital Los Angeles, Los Angeles, California We prospectively studied newborn infants with sepsis and neutropenia who were randomly selected to receive standard supportive care and either adjuvant g r a n u l o c y t e transfusions or intravenous immune globulin (IVIG) infusions; 21 infants received granulocyte transfusions and 14 r e c e i v e d IVIG infusions. Half of the patients were premature (gestational a g e __-90% were pure polymorphonuc|ear leukocytes as determined by microscopy. Granulocytes were transfused initially within 4 to 6 hours of diagnosis and were given twice a day during the first and second days of therapy; on
The Journal of Pediatrics February 1992
the third day of therapy granulocytes were administered once as a single infusion. This design was identical to our previous protocol and was intended to enhance both the quantitative and qualitative deficiencies of neonatal phagocytic immunity. Patients who were randomly selected to receive IVIG (Gamimune N) (5% immune globulin, pH 4.25, in 10% maltose solution) were given 1000 mg/kg intravenously during a 4- to 6-hour period each day during the first 3 days from the onset of neonatal sepsis. Similar supportive care was given to both groups of infants, including intravenous antibiotic therapy, fluid resuscitation, inotropic blood pressure support, and ventilator support for respiratory failure. Clinical and laboratory observations. The data were evaluated by a monitor unassociated with the clinical study. Demographic data collected on each patient included gestational age, postnatal age and weight at the start of the study, and presence or absence of prematurity. Severity of clinical illness was rated according to our previously established criteria 3 and was defined by one of the following: respiratory failure requiring an inspired oxygen concentration >--50% and ventilator support, acidosis with pH --
