Randomized controlled trial comparing different single doses of intravenous paracetamol for placement of peripherally inserted central catheters in preterm infants

__Background:__ The availability of a safe and effective pharmacological therapy to reduce procedural pain in preterm infants is limited. The effective analgesic single dose of intravenous paracetamol in preterm infants is unknown. Comparative studies on efficacy of different paracetamol doses in preterm infants are lacking. __Objectives:__ To determine the analgesic effects of different single intravenous paracetamol doses on pain from peripherally inserted central catheter (PICC) placement in preterm infants. __Methods:__ In a blinded randomized controlled trial, the an

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

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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

Defining small-for-gestational-age: prescriptive versus descriptive birthweight standards

Contains fulltext : 172268.pdf (publisher's version ) (Closed access)Descriptive population-based birthweight standards possess low sensitivity in detecting infants with growth impairment. A prescriptive birthweight standard based on a 'healthy' subpopulation without risk factors for intrauterine growth restriction might be superior. We created two birthweight standards based on live born, singleton infants with gestational age 24-42 weeks and born in The Netherlands between 2000 and 2007. Inclusion criteria for the prescriptive birthweight standard were restricted to infants without congenital malformations, born to healthy mothers after uncomplicated pregnancies. We defined small-for-gestational-age (SGA) as birthweight <10th percentile and assessed the ability of both standards to predict adverse neonatal outcomes. The prescriptive birthweight standard identified significantly more infants as SGA, up to 38.0 % at 29 weeks gestation. SGA infants classified according to both standards as well as those classified according to the prescriptive birthweight standard only, were at increased risk of both major and minor adverse neonatal outcomes. The prescriptive birthweight standard was both more sensitive and less specific, with a maximum increase in sensitivity predicting bronchopulmonary dysplasia (+42.6 %) and a maximum decrease in specificity predicting intraventricular haemorrhage (-26.9 %) in infants aged 28-31 weeks. CONCLUSION: Prescriptive birthweight standards could improve identification of infants born SGA and at risk of adverse neonatal outcomes. WHAT IS KNOWN: * Descriptive birthweight standards possess low sensitivity in detecting growth restricted infants at risk of adverse neonatal outcomes. * Prescriptive standards could improve identification of very preterm small-for-gestational-age (SGA) infants at risk of intraventricular haemorrhage. What is New: * Prescriptive standards identify more preterm and term SGA infants at risk of major adverse neonatal outcomes. * Late preterm and term SGA infants classified according to the prescriptive standard are at increased risk of minor adverse neonatal outcomes with potentially harmful implications

Short- and long-term outcome of infants born after maternal (pre)-eclampsia, HELLP syndrome and thrombophilia a retrospective, cohort study

To investigate the short- and long-term outcome of children born from mothers with pre-eclampsia, eclampsia and/or HELLP syndrome, and to determine the differences between children born from mothers with and without underlying thrombophilic disorder. Four hundred and nine infants (from 370 women) born between February 1991 and January 2006 were eligible for evaluation and were classified into group A (n = 162) and group B (n = 247). Thirty-four infants were not admitted to the hospital. Between-group differences were tested with regard to neonatal mortality, morbidity and follow-up measurements for neuromotor and mental development at 9 months and 2 years of age, using two-tailed Student's t-tests, Fisher's exact tests and logistic regression models. Of the 409 infants, 44 infants (10.8%; n = 20 group A/n = 24 group B) died. The mean gestational age in both groups was 31.9 (SD: 3.5) weeks. Of the 375 admitted infants 152 (40.5%) were related to a thrombophilic mother and 223 (59.5%) were not. Six children were lost to follow-up. At 9 months and 2 years of age development was assessed in 326 surviving children. At 9 months of age, 193 (59.2%; n = 66 group A/n = 127 group B) children showed a normal (52% group A versus 63.8% group B, P=0.046), 24 (7.4%; n = 9 group A/n = 15 group B) a suspect and 14 (4.3%; n = 6 group A, n=8 group B) an abnormal development during follow-up assessment. Ninety-five children (29.1%; n = 46 group A/n = 49 group B) did not have a follow-up assessment. At 2 years of age, 112 children (34.4%; n = 43 group A/n = 69 group B) had a normal, 21 (6.4%; n = 11 group A/n = 10 group B) a suspect and 17 (5.2%; n = 5 group A/n = 12 group B) an abnormal development. 176 children (54%; n = 70 group A/n = 106 group B) did not have a follow-up assessment. Short-term outcome was not different between infants from mothers with or without thrombophilic disorders. At 9 months of age, the probability of having a normal development was significantly lower in children born from a mother with an underlying thrombophilic disorder than in those without. At 2 years of age, no differences in development were observe

Prescriptive birthweight charts can improve the prediction of adverse outcomes in very preterm infants who are small for gestational age

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