The effect of clofibrate with phototherapy in late pre-term newborns with non-hemolytic jaundice. Randomized controlled trial of light-emitting diode phototherapy. Double versus single phototherapy in term newborns with significant hyperbilirubinemia. Effect of clofibrate in jaundiced term newborns. The Effect of Clofibrate on Decreasing Serum Bilirubin in Healthy Term Neonates under Home Phototherapy. Comparison of the efficacy of fiberoptic and conventional phototherapy for neonatal hyperbilirubinemia. Comparison of the efficacy of conventional special blue light phototherapy and fiberoptic phototherapy in the management of neonatal hyperbilirubinaemia. The effect of clofibrate on hyperbilirubinemia of term neonates. Light emitting diodes versus compact fluorescent tubes for phototherapy in neonatal jaundice: a multi center randomized controlled trial.
Despite an understanding of the enzymatic pathways leading to bilirubin production and degradation, very few pharmacologic interventions are utilized and the mainstay of treatment remains phototherapy.
                To evaluate the efficacy of clofibrate in reducing total serum bilirubin levels in late pre-term neonates with non-hemolytic jaundice.
                Double-blind, placebo-controlled, randomized trial; tertiary level neonatal unit.
                A randomized controlled study was carried out in the neonatal ward of Children's Hospital, Tabriz, Iran, over a 1-year period. Sixty-eight healthy late pre-term infants readmitted with non-hemolytic hyperbilirubinemia were randomized to receive phototherapy and clofibrate (n= 35) or phototherapy and placebo (n= 33).
                Chi-square test and independent sample 't' test.
                There were no significant differences in the weight, gender, modes of delivery and age of neonates between the two groups. Similarly the mean total serum bilirubin (TSB) level at the time of admission was not significantly different between the two groups [mean+/- SD: 19.72 +/- 1.79 (95% confidence interval: 19.12-20.54 mg/dL) vs. 20.05 +/- 2.82 (95% confidence interval, 19.54-22.04 mg/dL), P= 0.57]. The mean TSB 48 hours after phototherapy [mean+/- SD: 8.06+/- 1.34 (95% confidence interval: 7.94-10.18 mg/dL) vs.10.94 +/- 2.87 (95% confidence interval: 9.92-12.16 mg/dL), P= 0.02] and the mean duration of phototherapy [mean+/- SD: 64.32 +/- 12.48 (95% confidence interval: 60-81.6 hours) vs. 87.84 +/- 29.76 (95% confidence interval: 79.2-108 hours), P< 0.001] were significantly lower in the clofibrate-treated group.
                Clofibrate is an effective adjunctive drug in neonatal hyperbilirubinemia, which results in decreased TSB level and reduced duration of phototherapy in late pre-term newborns. We wished to compare the efficacy of light-emitting diode (LED) phototherapy with special blue fluorescent (BB) tube phototherapy in the treatment of neonatal hyperbilirubinemia.
                We randomly assigned 66 infants >or=35 weeks of gestation to receive phototherapy using an LED device or BB. In addition to phototherapy from above, all infants also received phototherapy from below using four BB tubes or a fiberoptic pad.
                After 15+/-5 h of phototherapy, the rate of decline in the total serum bilirubin (TSB) was 0.35+/-0.25 mg/dl/h in the LED group vs 0.27+/-0.25 mg/dl/h in the BB group (P=0.20).
                LED phototherapy is as effective as BB phototherapy in lowering serum bilirubin levels in term and near-term newborns. The efficacy of double phototherapy, in the form of conventional phototherapy with special blue light plus fiberoptic phototherapy, was compared with conventional phototherapy consisting of special blue lamps alone in a relatively larger series of term newborns with significant hyperbilirubinemia. During the study period the sum of the average spectral irradiances in the double phototherapy group was significantly higher than that of the single phototherapy group (p < 0.05). Phototherapy was effective in decreasing bilirubin levels in both groups, but the response was greater in the double phototherapy group; the duration of exposure to phototherapy was significantly shorter (31.2 +/- 8.5 vs. 38.98 +/- 14.7 h, p < 0.05), and the overall bilirubin decline rate as mumol/l/h and per cent/h was significantly greater in the double phototherapy group (4.1 +/- 1.37 vs. 3.3 +/- 0.86 mumol/l/h, and 1.29 +/- 0.38 vs. 1.02 +/- 0.44 per cent/h, p < 0.05). In phototherapy treatment of term newborns with significant hyperbilirubinemia, double phototherapy provided more rapid and effective bilirubin reduction than conventional phototherapy alone due to higher spectral irradiance and larger body surface area exposed to phototherapy. The value of double phototherapy in the treatment of newborns with hemolytic hyperbilirubinemia remains to be determined. Clofibrate is a glucuronosyl transferase inducer that has been proposed to increase the elimination of bilirubin in neonates with hyperbilirubinemia. The aim of this study was to characterize the therapeutic effect of clofibrate in neonates born at full term and present with non-hemolytic jaundice.
                A clinical controlled study was performed in two groups of healthy full term neonates. Thirty neonates were treated with a single oral dose of clofibrate (100 mg/kg) plus phototherapy (clofibrate-treated group) while another 30 neonates (control group) received only phototherapy.
                The mean plasma total bilirubin levels of 12th, 24th and 48th hours were significantly lower in the clofibrate-treated group as compared with the control group (P < 0.0001, P < 0.0001 and P = 0.004, respectively). Treatment with clofibrate also resulted in a shorter duration of jaundice and a decreased use of phototherapy (P < 0.0001). No side effects were observed.
                Although other pharmacological agents such as metalloporphyrins and Sn-mesoporphyrin also seem to be effective in decreasing bilirubin production, these products are not available for routine use and cannot be used because the safety of these drugs has to be confirmed prior to their widespread use. Therefore, clofibrate is now the only available pharmacological treatment of neonatal jaundice. This study was designed to determine the effect of clofibrate on neonatal uncomplicated jaundice treated with home phototherapy.
                This clinical trial study was performed on 60 newborns with jaundice that received home phototherapy. Inclusion criteria were body weight between 2500 to 4000 gr, breastfed, total serum bilirubin (TSB) between 14 to 20 mg/dl, aged over 72 hours. The neonates were randomly divided into two groups. All received home phototherapy. Group I received a single dose of 50 mg/kg clofibrate and the other group served as control group. Total serum bilirubin level was measured every 24 hours.
                Two groups were matched regarding weight, sex, age and first TSB. At 24 and 48 hours of treatment, the mean values of TSB in the clofibrate group were 13.72 (1.56), 9.5 (0.56) and in the control group 15.30 (1.44), 12.6 (1.44). The results show that TSB was significantly decreased after 24 and 48 hours in clofibrate group (P<0.001). The mean duration of phototherapy in group I was 72(0.0) hours and in the control group 76.80 (±9.76) hours. The duration of phototherapy was significantly shorter in clofibrate group (P<0.001).
                Clofibrate is effective for outpatients with neonatal hyperbilirubinemia who are under home phototherapy. Of course, further studies are needed for approved routine use of this drug in the treatment of neonatal jaundice. A comparative evaluation of the efficacy of fiberoptic phototherapy using the Ohmeda Billiblanket fiberoptic device, conventional phototherapy using daylight fluorescent lamps, and a combination of the two forms of phototherapy was made in 165 term healthy infants and 105 preterm infants with hyperbilirubinemia. In the term infants, the 24-hour decline rate for fiberoptic phototherapy was 9.2% +/- 1.6% (mean +/- SEM) versus 21.5% +/- 1.8% for daylight phototherapy (p < 0.01), and the overall decline rate was 0.49% +/- 0.03%/hr versus 0.70% +/- 0.04%/hr (p < 0.001). Combination phototherapy, with a 24-hour decline rate of 29.9% +/- 1.0% and an overall decline rate of 0.97% %/- 0.04%/hr, was significantly better than daylight phototherapy in both respects (p < 0.01 and < 0.01, respectively). The duration of exposure for fiberoptic phototherapy was significantly longer than that for daylight phototherapy, which in turn was significantly longer than that for combination phototherapy. Response to exposure in the preterm infants was significantly better than that in the term infants with the respective types of phototherapy. The nursing personnel unanimously felt more comfortable with fiberoptic phototherapy, which did not disturb the swaddled infants as much as conventional phototherapy. The parents also felt more reassured. Fiberoptic phototherapy proved adequate in controlling hyperbilirubinemia in preterm infants; in term infants, failures often occurred. Combination phototherapy can be recommended for severe or rapidly increasing jaundice in preterm infants, but its efficacy in term infants is uncertain. The efficacy and usefulness of two types of phototherapy differing in the source, wavelength and irradiance of the light, conventional phototherapy consisting of special blue light and fiberoptic phototherapy, were compared in a relatively larger series of term newborns with non-haemolytic and more significant hyperbilirubinaemia than those in previous studies. In total, 108 newborns were allocated sequentially to receive either conventional phototherapy consisting of five special blue lamps or fiberoptic phototherapy. The average spectral irradiance measured at the skin surface level of newborns during the study period was significantly greater in the conventional phototherapy group. The special blue lamp of the conventional phototherapy unit had an emission spectrum almost identical to the bilirubin absorption spectrum, whereas the tungsten-halogen lamp of the fiberoptic phototherapy had a broad emission through the blue and green wavelengths (mainly in the green spectrum). Phototherapy was more effective in the conventional phototherapy group; the duration of exposure to phototherapy (h) was significantly shorter, and the overall bilirubin decline rate (as micromol/l/h and %/h) was significantly greater in the conventional phototherapy group. According to the nursing personnel, fiberoptic phototherapy was more comfortable than the conventional phototherapy frame because of the easier accessibility and handling of the infants during phototherapy. They complained of giddiness, nausea, glare, temporary blurring of vision and difficulty in detecting the skin colour changes of newborns with the blue light of the conventional phototherapy unit. Conventional phototherapy consisting of special blue fluorescent lamps with approximately twofold higher irradiance and an emission spectrum almost identical to the bilirubin absorption spectrum is preferable to fiberoptic phototherapy in the standard treatment of term newborns with non-haemolytic hyperbilirubinaemia. Clofibrate is a glucuronosyl transferase inducer that has been proposed to increase the elimination of bilirubin in neonates with hyperbilirubinemia. This study was conducted to determine the therapeutic effect of clofibrate in term neonates with non-hemolytic jaundice. This study was conducted on 52 newborns with pathologic unconjugated jaundice in Qazvin children hospital. Newborns divided randomly in two groups. Case group treated with clofibrate and intensive phototherapy, while control group treated only with intensive phototherapy. Serum bilirubin level was measured before and 6, 12, 24 and 48 hours after treatment. Results were compared and analyzed. The mean serum level of bilirubin before treatment in the case and control groups were 20.78 ± 2.38 and 20.52 ± 2.44 mg/dl, respectively (P=0.69). The mean serum level of bilirubin in 6, 12, 24 and 48 hours after treatment in the case group were 18.20 ± 2.20, 14.70 ± 2.06, 10.72 ± 2.40 and 8.90 ± 0.83 mg/dl , respectively. These values in control group were 18.26 ± 2.42, 15.36 ± 2.59, 12.29 ± 2.28 and 10.23 ± 1.50 mg/dl, respectively. There was significant difference between two groups regarding mean serum level of bilirubin 24 hours (P=0.019) and 48 hours after treatment (P=0.005). In conclusion, clofibrate was effective in reducing neonatal jaundice and its effect appeared 24 hours after treatment. To evaluate whether light-emitting diode (LED) phototherapy is as efficacious as compact fluorescent tube (CFT) phototherapy for the treatment of non-hemolytic jaundice in healthy term and late preterm neonates.
                Multi centre open label randomized controlled trial.
                Four tertiary care neonatal units.
                Healthy term and late preterm neonates with non-hemolytic jaundice.
                Single-surface LED or CFT phototherapy. PRIMARY OUTCOME VARIABLE: Duration of phototherapy.
                A total of 272 neonates were randomized to receive LED (n=142) or CFT (n=130) phototherapy. The baseline demographic and biochemical variables were similar in the two groups. The median duration of phototherapy (IQR) in the two groups was comparable (26 (22-36) h vs. 25(22-36) h; P=0.44). At any time point, a similar proportion of neonates were under phototherapy in the two groups (log-rank test, P=0.38). The rate of fall of serum total bilirubin (STB) during phototherapy and the incidence of failure of phototherapy were also not different. An equal proportion of neonates had a rebound increase in STB needing restarting of phototherapy. Side effects were rare, comparable in the two groups and included hypothermia, hyperthermia, rash, skin darkening and dehydration.
                LED and CFT phototherapy units were equally efficacious in the management of non-hemolytic hyperbilirubinemia in healthy term and late preterm neonates.
There are insufficient data from different countries on the use of clofibrate in combination with phototherapy for hyperbilirubinaemia to make recommendations for practice. There is a need for larger trials to determine how effective clofibrate is in reducing the need for, and duration of, phototherapy in term and preterm infants with hyperbilirubinaemia.