Effectiveness of single versus double volume exchange transfusion in newborn infants with AB0 hemolytic disease. The role of exchange transfusions in the management of low-birth-weight infants with and without severe respiratory distress syndrome. II. Further observations and studies of mechanisms of action. The Premature Infants in Need of Transfusion (PINT) study: a randomized, controlled trial of a restrictive (low) versus liberal (high) transfusion threshold for extremely low birth weight infants. Randomized trial of liberal versus restrictive guidelines for red blood cell transfusion in preterm infants. High-dose intravenous immune globulin therapy for hyperbilirubinemia caused by Rh hemolytic disease. Effect of blood transfusions on the outcome of very low body weight preterm infants under two different transfusion criteria. Neonatal hyperviscosity: randomized study of effect of partial plasma exchange transfusion on long-term outcome. Rapid infusion of sodium bicarbonate and albumin into high-risk premature infants soon after birth: a controlled, prospective trial. Effect of clofibrate in jaundiced full-term infants:a randomized clinical trial.
The effectiveness of early single volume exchange transfusion (ET; 80 ml/kg) was compared with that of early double volume exchange transfusion (160 ml/kg) for treatment of hemolytic disease of the newborn caused by AB0 incompatibility. Twenty full-term infants with AB0 hemolytic disease were randomized into the two treatment groups. The groups were comparable for gestational age, body weight, hemoglobin values, reticulocyte count, maximum serum bilirubin levels, rate of rise of serum bilirubin before ET, antibody titer, and age at time of ET (all p greater than 0.05). The efficacy of treatment was similar in both groups taking into account the mean bilirubin level after ET, post-ET bilirubin, duration of phototherapy following ET, and frequency of second ET (all p greater than 0.05). However, platelet count immediately after ET was lower in the double volume ET group as compared to the single volume ET group (p less than 0.01). Hemoglobin values immediately after ET were higher in the double volume ET group (p less than 0.01). At ten days of life no differences were detectable. The results of this study indicate that the effectiveness of single volume ET for treatment of full-term infants with jaundice due to AB0 incompatibility is at least comparable to that of double exchange ET. Furthermore, the lesser aggressive approach determines less complications such as a decrease of platelet count. Exchange transfusion, as a form of therapy, was contrasted with the use of fresh frozen plasma or conventional supportive care alone in the management of 19 infants with birth weights of less than 1,000 gm, without severe respiratory distress, and in the management of 82 infants, birth weights less than 2,000 gm, with severe respiratory distress whose disease manifested itself within the first 24 hours of life. Survival for more than five days was similar, regardless of therapy, in infants weighing less than 1,000 gm without severe RDS. In contrast, the use of exchange transfusion significantly decreased the case fatality rate of infants with severe RDS. In the groups receiving exchange transfusion, the mortality rate was 41%, whereas the groups receiving either plasma or supportive care alone the mortality was 80%. Study of coagulation factors and red cell concentrations of fetal hemoglobin and of 2,3-DPG failed to demonstrate any relationship between either improvement in coagulation or oxygen unloading and the improved survival of infants receiving exchange transfusion. Following exchange transfusion there was a significant decrease in the ratio of FIO2 to PaO2, suggesting that pulmonary perfusion and/or ventilation was improved by the procedure. To determine whether extremely low birth weight infants (ELBW) transfused at lower hemoglobin thresholds versus higher thresholds have different rates of survival or morbidity at discharge.
                Infants weighing <1000 g birth weight were randomly assigned within 48 hours of birth to a transfusion algorithm of either low or high hemoglobin transfusion thresholds. The composite primary outcome was death before home discharge or survival with any of either severe retinopathy, bronchopulmonary dysplasia, or brain injury on cranial ultrasound. Morbidity outcomes were assessed, blinded to allocation.
                Four hundred fifty-one infants were randomly assigned to low (n = 223) or high (n = 228) hemoglobin thresholds. Groups were similar, with mean birth weight of 770 g and gestational age of 26 weeks. Fewer infants received one or more transfusions in the low threshold group (89% low versus 95% high, P = .037). Rates of the primary outcome were 74.0% in the low threshold group and 69.7% in the high (P = .25; risk difference, 2.7%; 95% CI -3.7% to 9.2%). There were no statistically significant differences between groups in any secondary outcome.
                In extremely low birth weight infants, maintaining a higher hemoglobin level results in more infants receiving transfusions but confers little evidence of benefit. Although many centers have introduced more restrictive transfusion policies for preterm infants in recent years, the benefits and adverse consequences of allowing lower hematocrit levels have not been systematically evaluated. The objective of this study was to determine if restrictive guidelines for red blood cell (RBC) transfusions for preterm infants can reduce the number of transfusions without adverse consequences.
                We enrolled 100 hospitalized preterm infants with birth weights of 500 to 1300 g into a randomized clinical trial comparing 2 levels of hematocrit threshold for RBC transfusion.
                The infants were assigned randomly to either the liberal- or the restrictive-transfusion group. For each group, transfusions were given only when the hematocrit level fell below the assigned value. In each group, the transfusion threshold levels decreased with improving clinical status.
                We recorded the number of transfusions, the number of donor exposures, and various clinical and physiologic outcomes.
                Infants in the liberal-transfusion group received more RBC transfusions (5.2 +/- 4.5 [mean +/- SD] vs 3.3 +/- 2.9 in the restrictive-transfusion group). However, the number of donors to whom the infants were exposed was not significantly different (2.8 +/- 2.5 vs 2.2 +/- 2.0). There was no difference between the groups in the percentage of infants who avoided transfusions altogether (12% in the liberal-transfusion group versus 10% in the restrictive-transfusion group). Infants in the restrictive-transfusion group were more likely to have intraparenchymal brain hemorrhage or periventricular leukomalacia, and they had more frequent episodes of apnea, including both mild and severe episodes.
                Although both transfusion programs were well tolerated, our finding of more frequent major adverse neurologic events in the restrictive RBC-transfusion group suggests that the practice of restrictive transfusions may be harmful to preterm infants. We conducted a multicenter controlled trial to test the hypothesis that high-dose intravenous immune globulin (HDivIG) therapy can modulate bilirubin production and reduce the frequency of exchange transfusions in newborn infants with Rh hemolytic disease. Thirty-four patients with Rh incompatibility proved by positive direct antiglobulin test (Coombs test) results were randomly assigned to receive conventional treatment including phototherapy, with or without additional HDivIG therapy at 500 mg/kg given for a 2-hour period as soon as the diagnosis was established. Exchange transfusions were performed if serum bilirubin concentrations exceeded the modified curves of Polácek by more than 2 mg/dl. Two patients were excluded because of protocol violations. The results in 32 infants were analyzed. In the HDivIG group, 2 (12.5%) of 16 children required exchange transfusions, whereas it became necessary in 11 (69%) of 16 children in the control group (p less than 0.005). Bilirubin levels in the HDivIG group were lower despite reduced frequency of exchange transfusions. No side effects of HDivIG treatment were observed. We conclude that HDivIG therapy by a yet unknown mechanism reduces serum bilirubin levels and the need for blood exchange transfusions in children with Rh hemolytic disease. Multiple packed red blood cell (PRBC) transfusions in very low birth weight (VLBW) prematurity have been suggested to be a risk factor for the development of retinopathy of prematurity (ROP) or for chronic lung disease (CLD). The purpose of this study was to examine the effect of PRBC transfusions on the outcome of VLBW prematurity.
                In total, between July 2005 and June 2006, 36 VLBW preterm babies were admitted to our neonatal intensive care unit and were randomly allocated to the "restrictive" (n= 19) or "liberal" (n= 17) criteria for PRBC transfusion. Complete blood count (CBC) was examined at admission and 30 days later. Reticulocyte counts, serum iron and ferritin were examined and compared with the clinical outcomes.
                Infants in the liberal group received a larger PRBC transfusion volume compared with the restrictive group over 30 days (41.7+/-20.1 vs. 27.2+/-15.9mL, p=0.029). There were no significant differences in the proportion of patients with respiratory distress syndrome, patent ductus arteriosus, severe intraventricular hemorrhage, ROP or CLD between the two groups. The laboratory data, except reticulocyte count, showed no significant difference on day 30. Further analysis of premature babies with and without CLD showed that total transfused blood volume greater than 30mL over 30 days was a risk factor for developing CLD in VLBW infants.
                Both criteria of PRBC transfusion had similar clinical outcomes, although liberal transfusion resulted in a greater amount of blood transfused and a low reticulocyte count at 30 days of age. We suggest restrictive criteria for minimizing the overall amount of transfusion to less than 30 mL may be a better way of preventing CLD in VLBW infants. The use of partial plasma exchange transfusion in newborns with polycythemia and hyperviscosity was evaluated. Ninety-three infants with polycythemia and hyperviscosity were randomly assigned to receive either partial plasma exchange transfusion or symptomatic treatment; the infants were matched with control infants without polycythemia. Neonatal course and outcome at 1 and 2 years were evaluated for each of the three groups. Polycythemic infants had more fine motor and speech problems at 1 year of age than did control infants. At 2 years of age, polycythemic infants had more gross motor delays, neurologic diagnoses, fine motor abnormalities, and speech delays than did the control infants. There was no significant difference at 1 year between the polycythemic infants who had received partial plasma exchange transfusion and those given only symptomatic care. At 2 years, the group receiving partial plasma exchange transfusion had fewer neurologic diagnoses and fine motor abnormalities. We conducted a controlled, prospective trial to evaluate the effectiveness of rapidly infusing sodium bicarbonate (NaHCO3) and salt-poor albumin into high-risk, premature infants in the first 2 hours of life. Fifty-three infants, randomized into one of four treatment groups, received 8 ml. per kilogram of a solution containing either (A) glucose in water, (B) salt-poor albumin, (C) NaHCO3, or (D) a combination of albumin and NaHCO3. After the initial infusion, the babies received no colloid or alkali solutions until 4 hours of age. We managed them supportively with warmth, appropriate oxygen administration, isotonic fluid infusion, and close monitoring. Among the infants who received alkali, 14 of 26 acquired the respiratory distress syndrome (RDS), 11 died, and four had intracranial hemorrhage. Among babies who received no alkali, RDS occurred in 11 of 27, 5 died, and none had intracranial hemorrhage. These results do not support the common practice of rapidly infusing NaHCO3 into high-risk, premature infants, and they suggest that the early management of such infants needs renewed critical evaluation. Hyperbilirubinemia is a common problem in newborn infants. It can progress to kernicterus in severe forms, unless an intervention is initiated. The objective of this study was to determine the therapeutic effect of clofibrate in full-term neonates with nonhemolytic jaundice.
                A randomized clinical trial was performed on two groups of full-term jaundiced neonates: the clofibrate-treated group (n = 30) and the control group (n = 30). Infants in the clofibrate group received a single oral dose of 100 mg/kg clofibrate while the neonates in the control group received distilled water (same color and volume); both groups received phototherapy. Serum total and direct bilirubin levels were measured at the beginning, 16, 24, 48, and 74 hours, after the start of the trial.
                The mean+/-SD total serum bilirubin level of the control and clofibrate groups at enrollment was 17.5+/-2.3 and 18.2+/-1.9 mg/dL, respectively (P = 0.199). The mean+/-SD total serum bilirubin in the control and clofibrate groups after 48 hours was 11.4+/-2.4 and 10.1+/-2.4 mg/dL, respectively (P = 0.047). After 72 hours of intervention, 25 (83%) neonates of the clofibrate group and 16 (53%) of the control group were discharged with a total serum bilirubin of <10 mg/dL (P = 0.026). No side-effect was observed on serial examination during hospitalization, and on the first and seventh day after discharge.
                Clofibrate results in a faster decline in TSB, shorter duration of hospitalization and had no side effects in jaundiced full-term neonates.
There was insufficient evidence to support or refute the use of single volume exchange transfusion as opposed to double volume exchange transfusion in jaundiced newborns. A change from the current practice of double volume exchange transfusions for severe jaundice in newborns infant, cannot be recommended on current evidence.