NEOnatal Central-venous Line Observational study on Thrombosis (NEOCLOT): evaluation of a national guideline on management of neonatal catheter-related thrombosis

Developmen

The bilirubin albumin ratio in the management of hyperbilirubinemia in preterm infants to improve neurodevelopmental outcome: A randomized controlled trial - BARTrial

Background and Objective: High bilirubin/albumin (B/A) ratios increase the risk of bilirubin neurotoxicity. The B/A ratio may be a valuable measure, in addition to the total serum bilirubin (TSB), in the management of hyperbilirubinemia. We aimed to assess whether the additional use of B/A ratios in the management of hyperbilirubinemia in preterm infants improved neurodevelopmental outcome. Methods: In a prospective, randomized controlled trial, 615 preterm infants of 32 weeks' gestation or less were randomly assigned to treatment based on either B/A ratio and TSB thresholds (consensus-based), whichever threshold was crossed first, or on the TSB thresholds only. The primary outcome was neurodevelopment at 18 to 24 months' corrected age as assessed with the Bayley Scales of Infant Development III by investigators unaware of treatment allocation. Secondary outcomes included complications of preterm birth and death. Results: Composite motor (100±13 vs. 101±12) and cognitive (101±12 vs. 101±11) scores did not differ between the B/A ratio and TSB groups. Demographic characteristics, maximal TSB levels, B/A ratios, and other secondary outcomes were similar. The rates of death and/or severe neurodevelopmental impairment for th

NEOnatal Central-venous Line Observational study on Thrombosis (NEOCLOT): Evaluation of a national guideline on management of neonatal catheter-related thrombosis

Background: In critically ill (preterm) neonates, central venous catheters (CVCs) are increasingly used for administration of medication or parenteral nutrition. A serious complication, however, is the development of catheter-related thrombosis (CVC-thrombosis), which may resolve by itself or cause severe complications. Due to lack of evidence, management of neonatal CVC-thrombosis varies among neonatal intensive care units (NICUs). In the Netherlands an expert-based national management guideline has been developed which is implemented in all 10 NICUs in 2014. Methods: The NEOCLOT study is a multicentre prospective observational cohort study, including 150 preterm and term infants (0-6 months) admitted to one of the 10 NICUs, developing CVC-thrombosis. Patient characteristics, thrombosis characteristics, risk factors, treatment strategies and outcome measures will be collected in a web-based database. Management of CVC-thrombosis will be performed as recommended in the protocol. Violations of the protocol will be noted. Primary outcome measures are a composite efficacy outcome consisting of death due to CVC-thrombosis and recurrent thrombosis, and a safety outcome consisting of the incidence of major bleedings during therapy. Secondary outcomes include individual components of primary efficacy outcome, clinically relevant non-major and minor bleedings and the frequency of risk factors, protocol variations, residual thrombosis and post thrombotic syndrome. Discussion: The NEOCLOT study will evaluate the efficacy and safety of the new, national, neonatal CVC-thrombosis guideline. Furthermore, risk factors as well as long-term consequences of CVC-thrombosis will be analysed

Bilirubin Standardization in the Netherlands: Alignment within and between Manufacturers

Afdeling Klinische Chemie en Laboratoriumgeneeskunde (AKCL

Uniform treatment thresholds for hyperbilirubinemia in preterm infants: background and synopsis of a national guideline

Item does not contain fulltextBACKGROUND: To prevent severe hyperbilirubinemia and bilirubin neurotoxicity, the American Academy of Pediatrics' management guideline for hyperbilirubinemia in near term infants is used worldwide. A leading guideline for jaundiced preterm infants is lacking whereas the risk on severe hyperbilirubinemia is high in these infants. Our aim was to define uniform treatment thresholds for jaundiced preterm infants. In this article we present the history and a synopsis of this novel national guideline. STUDY DESIGN: A survey on guidelines for hyperbilirubinemia in preterm infants was sent to all Dutch Neonatal Intensive Care Units (NICUs). After comparison with international guidelines, a new consensus-based guideline was developed. Results : Treatment thresholds of all 10 NICUs were based on Total Serum Bilirubin (TSB) and related to birth weight (n = 9) and gestational age (n = 1). NICUs used age-specific (n = 6) or fixed (n = 4) TSB-thresholds resulting in a large range of thresholds (maximal 170 mumol/L for phototherapy and 125 mumol/L for exchange transfusion). Acidosis, asphyxia, sepsis, active hemolysis and intraventricular hemorrhage were the most frequently used risk factors. Consensus was agreed upon TSB-based treatment thresholds, categorized in 5 birth weight groups and divided in high and low risk infants. CONCLUSION: There was no standardized care for jaundiced preterm infants in the Netherlands. In addition to the internationally used guideline for (near) term infants, a novel "consensus based" guideline for preterm infants with a gestational age of less than 35 weeks has been developed and implemented in the Netherlands. This guideline is approved and recommended by the Dutch Society of Pediatrics

Evaluation of Treatment Thresholds for Unconjugated Hyperbilirubinemia in Preterm Infants: Effects on Serum Bilirubin and on Hearing Loss?

Background:Severe unconjugated hyperbilirubinemia may cause deafness. In the Netherlands, 25% lower total serum bilirubin (TSB) treatment thresholds were recently implemented for preterm infants.Objective:To determine the rate of hearing loss in jaundiced preterms treated at high or at low TSB thresholds.Design/Methods:In this retrospective study conducted at two neonatal intensive care units in the Netherlands, we included preterms (gestational age 35 dB).Results:There were 479 patients in the high and 144 in the low threshold group. Both groups had similar gestational ages (29.5 weeks) and birth weights (1300 g). Mean and mean peak TSB levels were significantly lower after the implementation of the novel thresholds: 152±43 μmol/L and 212±52 μmol/L versus 131±37 μmol/L and 188±46 μmol/L for the high versus low thresholds, respectively (P<0.001). The incidence of hearing loss was 2.7% (13/479) in the high and 0.7% (1/144) in the low TSB threshold group (NNT = 50, 95% CI, 25-3302).Conclusions:Implementation of lower treatment thresholds resulted in reduced mean and peak TSB levels. The incidence of hearing impairment in preterms with a gestational age <32 weeks treated at low TSB thresholds was substantially lower compared to preterms treated at high TSB thresholds. Further research with larger sample sizes and power is needed to determine if this effect is statistically significant. © 2013 Hulzebos et al

Intestinal fatty acid-binding protein as a diagnostic marker for complicated and uncomplicated necrotizing enterocolitis: a prospective cohort study

BACKGROUND: Early NEC symptoms are non-specific and diagnostic tests lack discriminative power. Intestinal fatty acid-binding protein (I-FABP), mainly located in small bowel enterocytes, is released into the blood following NEC-associated enterocyte disruption. Aim of this prospective cohort trial was to determine the diagnostic value of I-FABP measured in plasma (I-FABPp) and urine (I-FABPu) for the presence of NEC, to evaluate I-FABP levels during NEC development, and to assess its prognostic value for the progression from suspected to complicated disease. METHODS: Between 2010 and 2012 we prospectively enrolled neonates with suspected NEC. We measured I-FABP levels eight-hourly from onset of suspected NEC for at least 48 hours, or until surgery. NEC diagnosis was confirmed radiologically or during operation. We defined NEC as complicated if it resulted in surgery and/or death. We determined disease course and diagnostic I-FABP cut-off points. RESULTS: The study comprised 37 neonates (24M, 13F), gestational age 28 (24-36) weeks, birth weight 1190 (570-2,400) grams. We found significantly higher I-FABPp and I-FABPu levels in NEC patients (n = 22) than in patients with other diagnoses (n = 15). Cut-off values for diagnosing NEC were 9 ng/mL I-FABPp and 218 ng/mL I-FABPu, with corresponding likelihood ratios (LRs) of 5.6 (95% CI 0.89-35) and 5.1 (95% CI 0.73-36), respectively. I-FABP levels were highest in the first eight hours after symptom onset and gradually decreased over time. Cut-off values for complicated disease were 19 ng/mL I-FABPp and 232 ng/mL I-FABPu, with LRs of 10 (95% CI 1.6-70) and 11 (95% CI 1.6-81), respectively. CONCLUSIONS: Both plasma and urinary I-FABP levels specifically identify NEC in preterm infants prior to appearance of diagnostic radiological signs suggestive for NEC. Moreover, serial I-FABP measurements accurately predict development of complicated disease

Intestinal fatty acid-binding protein in neonates with imminent necrotizing enterocolitis.

BACKGROUND: Intestinal fatty acid-binding protein (I-FABP) is a promising marker for necrotizing enterocolitis (NEC). It can be measured in plasma (I-FABPp) and urine (I-FABPu). Data on the best way to measure I-FABP (in plasma or urine) and the necessity of simultaneous measurement of the urinary creatinine concentration to correct for physiological variations in urine concentration are not available. This holds also true for the reciprocal relation between I-FABPp, I-FABPu and other more conventional laboratory parameters. OBJECTIVES: To evaluate the above-mentioned correlations of I-FABP measurements in neonates with suspected NEC. METHODS: All neonates with suspected NEC were prospectively included. I-FABPp and I-FABPu were analyzed at regular intervals during the first 24 h after onset of symptoms. Correlation and agreement were assessed between these and other parameters (i.e., IL-6, WBC, platelet count, CRP, pH and lactate). Results : Included were 24 boys, 13 girls [median (range) GA 28 weeks (24-36), median birth weight 1,190 g (570-2,400)]. I-FABPu correlated strongly with I-FABPp (r 0.80, p < 0.001) with an adequate agreement. A very strong correlation between I-FABPu and I-FABPu/urine creatinine ratio (r 0.98, p < 0.001) existed. Correlations between I-FABPp/u and conventional parameters were moderate to strong until 8 h after onset of symptoms. CONCLUSION: In neonates with suspected NEC, I-FABPu correlates strongly with I-FABPp, offering an opportunity to choose the most appropriate way of measuring I-FABP. Calculating urinary IFABP/creatinine ratio seems redundant. Moderately strong correlations between I-FABPu and IL-6, WBC and lactate were found

Beyond plasma bilirubin: the effects of herapy and albumin on brain bilirubin levels in Gunn rats.

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High variability and low irradiance of phototherapy devices in Dutch NICUs

<p>Objective To evaluate phototherapy practices by measuring the irradiance levels of phototherapy (PT) devices.</p><p>Design Prospective study.</p><p>Setting Tertiary neonatal intensive care units.</p><p>Patients None.</p><p>Interventions Irradiance levels of PT devices used in the 10 Dutch Neonatal Intensive Care Units (NICUs) were measured according to the local PT practice patterns. The irradiance levels of all overhead and fibre-optic PT devices were measured with a radiometer using an infant silhouette model.</p><p>Results Eight different PT devices were used in the 10 NICUs; five were overhead devices and three fibre-optic pads. The median (range) irradiance level for overhead PT devices was 9.7 (4.3-32.6) mu W/cm(2)/nm and for fibre-optic pads 6.8 (0.8-15.6) mu W/cm(2)/nm. Approximately 50% of PT devices failed to meet the minimal recommended irradiance level of 10 mu W/cm(2)/nm. Maximal irradiance levels for overhead PT spot lights were inversely related to the distance between device and infant model (R2=0.33). The distances ranged from 37 cm to 65 cm.</p><p>Conclusions PT devices in the Dutch NICUs show considerable variability with often too low irradiance levels. These results indicate that suboptimal PT is frequently applied and may even be ineffective towards reducing total serum bilirubin levels. These results underline the need for greater awareness among all healthcare workers towards the requirements for effective PT including measurements of irradiance and distance.</p>