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  • 1
    ISSN: 1432-1076
    Keywords: Key words     Polycythaemia ; Neonate ; Exchange transfusion
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract      We tested whether crystalliod solutions could be used instead of colloid solutions for partial exchange transfusions (PET) in polycythaemic neonates because crystalloid solutions are cheap, carry no risk of anaphylactic reactions and can be sterilized. We randomly assigned 20 term neonates with venous haematocrit (Hct) 〉 0.65 l/l to PET with either a serum preparation (BISEKO) or Ringer solution. Plasma volume (PV) was measured with Evans blue dilution. Blood volume (BV) and red cell mass were calculated from PV and venous Hct. Before PET both serum and Ringer groups had the same Hct (0.69 (0.66–0.76) vs 0.69 (0.66–0.71) l/l; median (range)) and BV (108 (81–116) versus 96 (68–121) ml/kg. During PET an equivalent amount of blood was withdrawn stepwise (19 (14–26) versus 17 (13–25) ml/kg and replaced by either serum or Ringer solution. More of the Ringer solution (median 77%) than of the serum (median 36%) given left the intravascular space within 4 h after PET (P = 0.016); but there was no signficant difference in Hct after Ringer-PET compared to serum-PET (median 0.58 vs 0.56 l/l). No infant required repeat PET. Ringer-PET reduced BV from high to normal values (from median 96 to 83 ml/kg; P = 0.005), whereas after serum-PET BV remained high (from median 108 to 98 ml/kg; not significant). Conclusion     PET with Ringer solution resulted in a haemodilution comparable to PET with serum and a correction of hypervolaemia.
    Type of Medium: Electronic Resource
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  • 2
    ISSN: 1432-1076
    Keywords: Surfactant ; Idiopathic respiratory distress syndrome ; Clinical trial ; Randomization
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract We performed a multicenter prospective randomized controlled trial to determine the efficacy and safety of the surfactant preparation, Survanta (Abbott Laboratories, Chicago, USA), for 750–1750 g infants with idiopathic respiratory distress syndrome, (IRDS) receiving assisted ventilation with 40% or more oxygen. One hundred and six eligible infants from the eight participating centers were randomly assigned between March 1986 and June 1987 to receive either surfactant (100 mg phospholipid/kg, 4 ml/kg) or air (4 ml/kg) administered into the trachea within 8 h of brith (median time of treatment 6.2 h, range 3.2–9.1 h). The study was stopped before enrollment was completed at the request of the United States Food and Drug Administration when significant differences were observed in incidence of periventricular-intraventricular hemorrhage (PIH), between the surfactant treated and control infants. Surfactant treated infants had larger average increases in the arterial-alveolar oxygen ratio, (a/A ratio) (P〈0.0001), and larger average decreases in FiO2 (P〈0.0001) and mean airway pressure, (MAP) (P〈0.017) than controls over the 48 h following treatment. The magnitude of the differences between the surfactant and control groups were 0.19 (SE=0.03) for a/A ratio, −0.28 (SE=0.04) for FiO2 and −1.7 cm H2O (SE=0.70) for MAP. The clinical status on days 7 and 28 after treatment was classified using four predefined ordered categories: (1) no respiratory support; (2) supplemental O2 with or without continuous positive airway pressure (CPAP); (3) intermittent mandatory ventilation; and (4) death. There were no statistically significant differences in the status categories on days 7 or 28 between surfactant and control infants. There were no significant differences between the groups with respect to the incidence of patent ductus arteriosus, bronchopulmonary dysplasia, necrotizing entero-colitis, air leaks or death. There was a statistically significant difference between treated and control infants in the frequency and severity of periventricular-intraventricular hemorrhage (PIH) (Cochran-Mantel-Haenszelχ 2adj=6.36,P=0.01). Hemorrhages occurred in 59.6% of surfactant treated infants and 26.9% of controls. Severe hemorrhages (grades 3 or 4) occurred in 38.5% of surfactant treated infants and 15.4% of controls (χ 2adj=4.01,P=0.045). We conclude that the intratracheal administration of Survanta prior to 8 h of age to infants with IRDS receiving assisted ventilation with 40% or more oxygen results in a reduction in the severity of respiratory distress during the 48 h after therapy. Because of the difference in incidence of PIH between surfactant and control infants in this study, we recommend that future clinical trials of surfactant include more frequent prospective serial ultrasound evaluations for diagnosis of hemorrhage.
    Type of Medium: Electronic Resource
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