Efficacy of oral phenobarbitone in term "at risk" neonates in decreasing neonatal hyperbilirubinemia: a randomized double-blinded, placebo controlled trial.
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OBJECTIVE: To evaluate the efficacy of oral phenobarbitone in "at risk " term neonates (with high cord bilirubin) in decreasing hyperbilirubinemia. DESIGN: Double blind, placebo-control, randomized trial. SETTING: Tertiary level neonatal unit. OUTCOME: Primary-hyperbilirubinemia defined as total serum bilirubin (TSB) greater than 13 mg/dL. Secondary-TSB at 72 +/- 12 hr, need for phototherapy or exchange transfusion and side effects of phenobarbitone therapy. METHODS: All consecutively born term healthy neonates with cord bilirubin > or = 2.5 mg/dL were randomly assigned to receive either phenobarbitone (n = 37) or placebo (n = 38) after obtaining informed consent. Phenobarbitone was administered orally (5 mg/kg/day) for 3 days starting within 12 hours of birth. The neonates were followed up till seven days of life. TSB was estimated in neonates who developed jaundice with clinically assessed level of 8-10 mg/dL and at 72 +/-12 hours of age in 55 neonates. RESULTS: The baseline characteristics were similar in two groups. There was no significant reduction in incidence of hyperbilirubinemia in phenobarbitone group compared to in placebo group (6/37 (16.2%) versus 13/38 (34.3%); RR 0.47, 95% confidence interval: 0.20-1.11; risk difference: -18.1%, 95% confidence interval: -39.5 to 3.3%). However TSB at 72 +/-12 hours in phenobarbitone group (mean +/- S.D: 10.0 +/- 3.7 mg/dL) was significantly lesser than in placebo group (mean +/- S.D: 12.3 +/- 3.3 mg/dL) (difference of means: -2.3 mg/dL, 95% confidence interval: -3.9 to -0.7 mg/dl, P = 0.018). No significant difference with respect to need for treatment was observed in two groups. No significant adverse effects of phenobarbitone were noted. CONCLUSIONS: Prophylactic phenobarbitone is not helpful in reducing the incidence of hyper-bilirubinemia in "at risk" term neonates. (+info)
Significant correlations between the flow volume of patent ductus venosus and early neonatal liver function: possible involvement of patent ductus venosus in postnatal liver function.
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BACKGROUND: The biochemical features of portosystemic venous shunt with high flow volume are hypergalactosaemia, hyperammonaemia, prolonged blood coagulation time, and raised serum bile acid concentration. The ductus venosus remains open with shunt flow in most neonates for a certain period after birth. However, the effects of blood flow through the ductus venosus on neonatal liver function remain unclear. OBJECTIVE: To elucidate the effect of patency of the ductus venosus on liver function in early neonates. METHODS: Subjects were divided into three groups by gestational age (group I, 29-32 weeks; group II, 33-36 weeks; group III, 37-41 weeks). The shunt flow volume through the ductus venosus was examined serially using ultrasonography, and correlations between flow volume and liver function in the respective groups were calculated during the first week after birth. RESULTS: Group I had a higher flow volume and later functional closure than the other two groups. Plasma ammonia and serum total bile acid concentrations correlated with flow volume in groups I and II, and blood galactose and galactose 1-phosphate concentrations correlated significantly with flow volume in group III. Percentage hepaplastin also correlated significantly with flow volume in all groups, but plasma vitamin K concentration did not in any group. CONCLUSIONS: Patent ductus venosus has a considerable effect on crucial liver functions such as ammonia detoxification, blood coagulation, and regulation of serum total bile acid concentration in early neonates. (+info)
Toward understanding kernicterus: a challenge to improve the management of jaundiced newborns.
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PURPOSE: We sought to evaluate the sensitivity and specificity of total serum bilirubin concentration (TSB) and free (unbound) bilirubin concentration (Bf) as predictors of risk for bilirubin toxicity and kernicterus and to examine consistency between these findings and proposed mechanisms of bilirubin transport and brain uptake. METHODS: A review of literature was undertaken to define basic principles of bilirubin transport and brain uptake leading to neurotoxicity. We then reviewed experimental and clinical evidence that relate TSB or Bf to risk for bilirubin toxicity and kernicterus. RESULTS: There are insufficient published data to precisely define sensitivity and specificity of either TSB or Bf in determining risk for acute bilirubin neurotoxicity or chronic sequelae (kernicterus). However, available laboratory and clinical evidence indicate that Bf is better than TSB in discriminating risk for bilirubin toxicity in patients with severe hyperbilirubinemia. These findings are consistent with basic pharmacokinetic principles involved in bilirubin transport and tissue uptake. CONCLUSIONS: Experimental and clinical data strongly suggest that measurement of Bf in newborns with hyperbilirubinemia will improve risk assessment for neurotoxicity, which emphasizes the need for additional clinical evaluation relating Bf and TSB to acute bilirubin toxicity and long-term outcome. We speculate that establishing risk thresholds for neurotoxicity by using newer methods for measuring Bf in minimally diluted serum samples will improve the sensitivity and specificity of serum indicators for treating hyperbilirubinemia, thus reducing unnecessary aggressive intervention and associated cost and morbidity. (+info)
Management of neonatal hyperbilirubinemia: pediatricians' practices and educational needs.
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BACKGROUND: Early detection and treatment of neonatal hyperbilirubinemia is important in the prevention of bilirubin-induced encephalopathy. In this study, we evaluated the New Jersey pediatricians' practices and beliefs regarding the management of neonatal hyperbilirubinemia and their compliance with the recommendations made by the American Academy of Pediatrics (AAP) in 1994. METHODS: A survey questionnaire was mailed to a random sample of 800 pediatricians selected from a list of 1623 New Jersey Fellows of the AAP initially in October 2003 and then in February 2004 for the non-respondents. In addition to the physicians' demographic characteristics, the questionnaire addressed various aspects of neonatal hyperbilirubinemia management including the diagnosis, treatment, and follow up as well as the pediatricians' beliefs regarding the significance of risk factors in the development of severe hyperbilirubinemia. RESULTS: The adjusted response rate of 49.1% (n = 356) was calculated from the 725 eligible respondents. Overall, the practicing pediatricians reported high utilization (77.9%) of the cephalocaudal progression of jaundice and low utilization (16.1%) of transcutaneous bilirubinometry for the quantification of the severity of jaundice. Most of the respondents (87.4%) identified jaundice as an indicator for serum bilirubin (TSB) testing prior to the neonate's discharge from hospital, whereas post-discharge, only 57.7% felt that a TSB was indicated (P < 0.01). If the neonate's age was under 72 hours, less than one-third of the respondents reported initiation of phototherapy at TSB levels lower than the treatment parameters recommended by the AAP in 1994, whereas if the infant was more than 72 hours old, almost 60% were initiating phototherapy at TSB lower than the 1994 AAP guidelines. Most respondents did not regard neonatal jaundice noted after discharge and gestational ages 37-38 weeks as being significant in the development of severe hyperbilirubinemia. However, the majority did recognize the importance of jaundice presenting within the first 24 hours and Rh/ABO incompatibility. CONCLUSION: The pediatricians' practices regarding the low utilization of laboratory diagnosis for the quantification of jaundice after discharge and underestimation of risk factors that contribute to the development of severe hyperbilirubinemia are associated with initiation of phototherapy at lower than AAP recommended treatment parameters and recognition of neonatal hyperbilirubinemia as an important public health concern. (+info)
Transcutaneous bilirubin levels in the first 96 hours in a normal newborn population of > or = 35 weeks' gestation.
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OBJECTIVE: To obtain transcutaneous bilirubin (TcB) measurements, at 6-hour intervals, in the first 96 hours after birth in a normal newborn population (gestational age: > or =35 weeks). METHODS: We performed 9397 TcB measurements on 3984 healthy newborn infants (gestational age: > or =35 weeks) from 6 to 96 hours of age. All measurements were performed in the well-infant nursery with a Draeger Air-Shields transcutaneous jaundice meter (model JM-103), within 2 hours of the designated time. RESULTS: There was a distinct pattern to the velocity of the increase in TcB levels over different time periods. TcB levels increased in a linear manner most rapidly in the first 6 to 18 hours and then less rapidly from 18 to 42 hours, followed by a much slower increase until peak levels occurred. Decreasing gestational age was associated significantly with higher TcB levels. CONCLUSIONS: We provide data on neonatal bilirubinemia, based on TcB levels determined in a large, predominately white and breastfed, North American population. Infants who require closer evaluation and observation initially are those whose bilirubin levels are > or =95th percentile, ie, increasing more rapidly than 0.22 mg/dL per hour in the first 24 hours, 0.15 mg/dL per hour between 24 and 48 hours, and 0.06 mg/dL per hour after 48 hours. These data should be useful for detecting aberrant trends, identifying infants who need additional evaluation, and planning appropriate follow-up for jaundiced newborns. (+info)
Bilirubin measurement for neonates: comparison of 9 frequently used methods.
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OBJECTIVE: High blood concentrations of bilirubin are toxic to the brain and may cause kernicterus. Therefore, determination of bilirubin levels is performed for many newborns, and several different methods are available. We compared 9 frequently used methods for bilirubin determination among newborns under routine conditions, to define their sequence of use. METHODS: In a prospective study, bilirubin concentrations were determined with 9 different methods, ie, 3 skin test devices, 3 nonchemical photometric devices (including 2 blood gas analyzers), and 3 laboratory analyzers. RESULTS: A total of 124 samples were obtained. All 3 laboratory methods showed very strong correlations with each other, and their means were used as comparison values. To these comparison values, the skin test devices had correlation coefficients between 0.961 and 0.966, and the nonchemical photometric devices between 0.980 and 0.994. Bland-Altman plots demonstrated good agreement with the comparison values for all nonchemical photometric devices. All skin test devices and 1 nonchemical photometric device underestimated bilirubin levels, particularly at high concentrations. CONCLUSIONS: In the routine care of newborns, the first method for bilirubin testing should be a skin test. If the skin test result exceeds 200 micromol/L and other analytes are to be determined with a nonchemical photometric device, then bilirubin can be included in this analysis and the result trusted up to 250 micromol/L. If the skin test result exceeds 200 micromol/L and only bilirubin concentrations are needed, then a standard laboratory method is the first choice, to avoid repeated blood sampling. Bilirubin concentrations from nonchemical photometric devices that exceed 250 micromol/L should be confirmed with standard laboratory methods. (+info)
The effect of instituting a prehospital-discharge newborn bilirubin screening program in an 18-hospital health system.
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OBJECTIVE: Kernicterus is a rare but devastating condition. The prevention of bilirubin-induced brain injury is based on the detection of infants at risk for developing severe hyperbilirubinemia. In an 18-hospital health system, Intermountain Health Care (IHC), we initiated a program of predischarge bilirubin screening of all neonates and coupled this with a results assessment using a percentile-based nomogram. Data during 2 periods of time, before versus after initiating the program, were compared to assess the effect of the program on significant hyperbilirubinemia and rehospitalization. METHODS: We conducted a historic cohort study involving all neonates delivered at > or =35 weeks' gestation, within IHC's 18-hospital system, during 2 periods of time: March 1, 2001, to December 31, 2002, versus January 1, 2003, to December 31, 2004. A bilirubin screening program, instituted in December 2002, called for a total serum bilirubin (TSB) or transcutaneous bilirubin measurement to be performed on every neonate either at the recognition of clinical jaundice or before discharge regardless of whether jaundice was observed. For nonjaundiced neonates, the nursery staff was encouraged to obtain the screening TSB at the same time they obtained the state-mandated newborn screen for inborn errors of metabolism. Bilirubin values were plotted on an hour-specific nomogram and the corresponding percentile was used to guide evaluation, therapy, and follow-up. This study compared TSB data and readmission data for a 2-year period before versus a 2-year period after implementing the program. RESULTS: The study involved 101272 neonates: 48789 in period 1 and 52483 in period 2. Before the program, 1 in every 77 neonates born at an IHC hospital had 1 or more serum bilirubin levels >20 mg/dL. After initiating the program, the incidence fell to 1 in 142 and the number of neonates with a level >25 mg/dL fell from 1 in 1522 before to 1 in 4037 after. The rate of hospital readmission with a primary diagnosis of jaundice fell from 0.55% in period 1 to 0.43% in period 2. CONCLUSIONS: Initiating a program of bilirubin screening in a multihospital health system, coupled with evaluating the results using a percentile-based nomogram, reduced the proportion of neonates with significant hyperbilirubinemia and reduced the rate of hospital readmissions with jaundice. (+info)
The changing face of race: risk factors for neonatal hyperbilirubinemia.
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OBJECTIVES: Race is a predictor of health outcomes and risk for some clinical conditions, for example, mother's race predicts risk for hyperbilirubinemia in newborns, with blacks at lowest risk. Little is known about the correlation of race as recorded in medical records with self-reported race. Also, use of maternal race to predict newborn risk for hyperbilirubinemia has not been tested for multiracial mothers and newborns. We sought to examine how maternal race documented in medical records correlates with self-reported race and to examine the correlation between mothers' and newborns' race in the context of risk for neonatal hyperbilirubinemia, focusing on multiracial mothers and newborns. DESIGN: A cohort study with 3021 newborns at > or =35 weeks gestation discharged from normal nursery between January 2001 and October 2002 with a telephone survey of their mothers within 6 months of birth. SETTING: The study was conducted in the Neonatology Department of Henry Ford Hospital. PATIENTS: There were 1773 mothers (58%) with incorrect telephone numbers. Of 1248 mothers contacted, 866 (69%) completed the interview. OUTCOME MEASURES: We measured mother's race in hospital database and mother's reported race for herself, her newborn, and the father, allowing < or =5 responses for each. RESULTS: Of mothers documented in the medical record as white, 64% self-reported as white. Among mothers recorded as black, 70% self-reported as black. Mothers identified 93 newborns as > or =2 races with primary race matching both parents for 41%, father for 25%, mother for 23%, and neither parent for 11%. Of 70 newborns whose parents were not the same race, mothers identified 45 (64%) as > or =2 races. CONCLUSIONS: There is incomplete overlap between racial identification in medical records versus self-report. Given 1 choice, mothers of multiracial infants overselect black in their newborns' ancestry. Because black race is the lowest risk category for neonatal hyperbilirubinemia, this may lead to underestimating their risk. (+info)