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Romantsik O.,Skane University Hospital | Bruschettini M.,Skane University Hospital | Zappettini S.,Health Regional Agency of the Liguria Region | Ramenghi L.A.,Neonatal Intensive Care Unit | Calevo M.G.,Biostatistics and Committees Unit
Cochrane Database of Systematic Reviews | Year: 2016

This is the protocol for a review and there is no abstract. The objectives are as follows: To assess whether heparin treatment (both UFH and LMWH) in preterm and term newborn infants with diagnosed thrombosis reduces the rate of mortality and morbidity. The intervention will be compared to placebo or no treatment. In addition, the safety of heparin therapy (both UFH and LMWH) will be assessed for potential harms. Subgroup analyses will be performed regarding gestational age, birth weight, mode of thrombus diagnosis, presence of central line, positive family history for genetic disorders (thrombophilia, deficiency of protein S and protein C, MTHFR mutation), route of heparin administration, type of heparin used, and location of thrombus (see Subgroup analysis and investigation of heterogeneity). © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Source


Bruschettini M.,Lund University | Romantsik O.,Lund University | Zappettini S.,Health Regional Agency of the Liguria Region | Banzi R.,Mario Negri Institute for Pharmacological Research | And 2 more authors.
Cochrane Database of Systematic Reviews | Year: 2016

Background: Preterm birth remains the major risk factor for the development of intraventricular hemorrhage, an injury that occurs in 25% of very low birth weight infants. Intraventricular hemorrhage is thought to be venous in origin and intrinsic thromboses in the germinal matrix are likely to play a triggering role. Antithrombin, a glycoprotein synthesized in the liver, is the major plasma inhibitor of thrombin thus modulating blood coagulation. Very low birth weight newborn infants have low levels of antithrombin and the risk of developing intraventricular hemorrhage is increased by the presence of hypercoagulability in the first hours of life. The administration of anticoagulants such as antithrombin may offset the increased risk of developing intraventricular hemorrhage. Anticoagulants may also reduce the risk of developing parenchymal venous infarct, a condition known to complicate intraventricular hemorrhage. Objectives: To assess whether the prophylactic administration of antithrombin (started within the first 24 hours after birth) reduces the incidence of germinal matrix-intraventricular hemorrhage in very preterm neonates when compared to placebo, no treatment, or heparin. Search methods: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library 2015), MEDLINE (1996 to 22 November 2015), EMBASE (1980 to 22 November 2015), and CINAHL (1982 to 22 November 2015). No language restrictions were applied. We searched the abstracts of the major congresses in the field (Perinatal Society of Australia and New Zealand and Pediatric Academic Societies) from 2000 to 2015. Selection criteria: Randomised controlled trials, quasi-randomised controlled trials and cluster trials comparing the administration of early, i.e. within the first 24 hours of life, antithrombin in very preterm infants (gestational age < 32 weeks, any birth weight). Data collection and analysis: For each of the included trials, two authors independently extracted data (e.g. number of participants, birth weight, gestational age, antithrombin formulation (plasma-derived or recombinant), mode of administration, and duration of therapy, etc.) and assessed the risk of bias (e.g. adequacy of randomization, blinding, completeness of follow-up). The primary outcomes considered in this review are intraventricular hemorrhage and severe intraventricular hemorrhage. Main results: Two randomized controlled trials, for a total of 182 infants, met the inclusion criteria of this review. Both trials compared antithrombin with placebo. We found no significant differences in the rates of intraventricular hemorrhage (typical RR 1.30, CI 95% 0.87 to 1.93, typical RD 0.09, 95% CI -0.05 to 0.23; 2 studies, 175 infants; I2 = 18% for RR and I2 = 42% for RD) and severe intraventricular hemorrhage (typical RR 1.04, CI 95% 0.55 to 1.94; typical RD 0.01, 95% CI -0.11 to 0.12; 2 studies, 175 infants; I2 = 0% for RR and I2 = 0% for RD). Among secondary outcomes, we found no significant differences in terms of neonatal mortality (typical RR 2.00, CI 95% 0.62 to 6.45; typical RD 0.04, 95% CI -0.03 to 0.12; 2 studies, 182 infants; I2 = 46% for RR and I2 = 61% for RD) and in the other specified outcomes, such as bronchopulmonary dysplasia. The quality of the evidence supporting these findings is limited due to the imprecision of the estimates. Authors' conclusions: The administration of antithrombin seems not to reduce the incidence and severity of intraventricular hemorrhage in very preterm infants. Limited evidence is available on other clinically relevant outcomes. Given the imprecision of the estimate, the results of this systematic review are consistent with either a benefit or a detrimental effect of antithrombin and do not provide a definitive answer to the review question. © 2016 The Cochrane Collaboration. Source


Bruschettini M.,Lund University | Zappettini S.,Health Regional Agency of the Liguria Region | Moja L.,University of Milan | Calevo M.G.,Biostatistics and Committees Unit
Cochrane Database of Systematic Reviews | Year: 2016

Background: Endotracheal suctioning consists of the mechanical aspiration of pulmonary secretions from the endotracheal tube (ETT) to prevent obstruction. The optimal frequency of ETT suctioning has not been defined. Objectives: To determine the effect of specific ordered frequency of ETT suctioning ('as scheduled') versus ETT suctioning only in case of indications ('as needed') and of more frequent ETT suctioning versus less frequent ETT suctioning on respiratory morbidity in ventilated newborns. Search methods: We used the standard search strategy of the Cochrane Neonatal Review group to search the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 10), MEDLINE via PubMed (1966 to 31 October 2015), EMBASE (1980 to 31 October 2015), and CINAHL (1982 to 31 October 2015). We checked the reference lists of retrieved articles and contacted study authors to identify additional studies. We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi-randomized trials. Selection criteria: Randomized, quasi-randomized, and cluster randomized controlled trials comparing different strategies regarding the frequency of ETT suctioning of newborn infants receiving ventilator support. Data collection and analysis: We used the standard methods of the Cochrane Neonatal Review Group. Two review authors independently extracted data and assessed the risk of bias of trials. The primary outcome was bronchopulmonary dysplasia or chronic lung disease. Main results: We identified one randomized controlled study recruiting 97 low birthweight infants that met the inclusion criteria. The study was conducted in the UK in 1987 and 1988. Randomized infants received ETT suctioning every six or 12 hours during the first three days of life. The quality of reporting was limited and we rated the trial at high risk of bias. Furthermore, the trial lacked adequate power. There were no statistically significant differences in any of reported outcomes: bronchopulmonary dysplasia (defined as oxygen at more than 30 days; risk ratio (RR) 0.49, 95% confidence interval (CI) 0.20 to 1.20); incidence of pneumothorax (RR 0.70, 95% CI 0.24 to 2.05); intraventricular hemorrhage (RR 1.12, 95% CI 0.44 to 2.85); neonatal death (RR 1.40, 95% CI 0.58 to 3.37); and time on ventilation (median time 39 hours in the 12-hourly group and 28 hours in the six-hourly group; RD not applicable for this outcome as mean and standard deviation were not reported). Tests for heterogeneity were not applicable as only one study was included. Authors' conclusions: There was insufficient evidence to identify the ideal frequency of ETT suctioning in ventilated neonates. Future research should focus on the effects in the very preterm newborns, that is, the most vulnerable population as concerns the risk of both lung and brain damage. Assessment should include the cases of prolonged ventilation, when more abundant, dense secretions are common. Clinical trials might include comparisons between 'as-scheduled' versus 'as-needed' endotracheal suctioning, that is, based on specific indications, as well frequent versus less frequent suctioning schedules. © 2016 The Cochrane Collaboration. Source


Bruschettini M.,Lund University | Romantsik O.,Lund University | Zappettini S.,Health Regional Agency of the Liguria Region | Ramenghi L.A.,Neonatal Intensive Care Unit | Calevo M.G.,Biostatistics and Committees Unit
Cochrane Database of Systematic Reviews | Year: 2016

Background: Carbon dioxide (CO2) measurement is a fundamental evaluation in a neonatal intensive care unit (NICU), as both low and high values of CO2 might have detrimental effects on neonatal morbidity and mortality. Though measurement of CO2 in the arterial blood gas is the most accurate way to assess the amount of CO2, it requires blood sampling and it does not provide a continuous monitoring of CO2. Objectives: To assess whether the use of continuous transcutaneous CO2 (tcCO2) monitoring in newborn infants reduces mortality and improves short and long term respiratory and neurodevelopmental outcomes. Search methods: We used the standard search strategy of the Cochrane Neonatal Review group to search the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 11), MEDLINE via PubMed (1966 to November 1, 2015), EMBASE (1980 to November 1, 2015), and CINAHL (1982 to November 1, 2015). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi-randomized trials. Selection criteria: Randomized, quasi-randomized and cluster randomized controlled trials comparing different strategies regarding tcCO2 monitoring in newborns. Three comparisons were considered, that is, continuous tcCO2 monitoring versus 1) any intermittent modalities to measure CO2; 2) other continuous CO2 monitoring; and 3) with or without intermittent CO2 monitoring. Data collection and analysis: We used the standard methods of the Cochrane Neonatal Review Group. Two review authors independently assessed studies identified by the search strategy for inclusion. Main results: Our search strategy yielded 106 references. Two review authors independently assessed all references for inclusion. We did not find any completed studies for inclusion, nor ongoing trials. Authors' conclusions: There was no evidence to recommend or refute the use of transcutaneous CO2 monitoring in neonates. Well-designed, adequately powered randomized controlled studies are necessary to address efficacy and safety of transcutaneous CO2 monitoring in neonates. © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Source


Moresco L.,Pediatric and Neonatology Unit | Calevo M.G.,Biostatistics and Committees Unit | Baldi F.,Pediatric and Neonatology Unit | Cohen A.,Pediatric and Neonatology Unit | Bruschettini M.,Skane University Hospital
Cochrane Database of Systematic Reviews | Year: 2016

Background: Transient tachypnea of the newborn is characterized by tachypnea and signs of respiratory distress. Transient tachypnea typically appears within the first two hours of life in term and late preterm newborns. Although transient tachypnea of the newborn is usually a self limited condition, it is associated with wheezing syndromes in late childhood. The rationale for the use of epinephrine (adrenaline) for transient tachypnea of the newborn is based on studies showing that β-agonists can accelerate the rate of alveolar fluid clearance. Objectives: To assess whether epinephrine compared to placebo, no treatment or any other drugs (excluding salbutamol) is effective and safe in the treatment of transient tachypnea of the newborn in infants born at 34 weeks' gestational age or more. Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, 2016, Issue 3), MEDLINE (1996 to March 2016), EMBASE (1980 to March 2016) and CINAHL (1982 to March 2016). We applied no language restrictions. We searched the abstracts of the major congresses in the field (Perinatal Society of Australia and New Zealand and Pediatric Academic Societies) from 2000 to 2015. Selection criteria: Randomized controlled trials, quasi-randomized controlled trials and cluster trials comparing epinephrine versus placebo or no treatment or any other drugs administered to infants born at 34 weeks' gestational age or more and less than three days of age with transient tachypnea of the newborn. Data collection and analysis: For the included trial, two review authors independently extracted data (e.g. number of participants, birth weight, gestational age, duration of oxygen therapy (hours), need for continuous positive airway pressure and need for mechanical ventilation, duration of mechanical ventilation, etc.) and assessed the risk of bias (e.g. adequacy of randomization, blinding, completeness of follow-up). The primary outcomes considered in this review were duration of oxygen therapy (hours), need for continuous positive airway pressure and need for mechanical ventilation. Main results: One trial, which included 20 infants, met the inclusion criteria of this review. Study authors administered three doses of nebulized 2.25% racemic epinephrine or placebo. We found no differences between the two group in the duration of supplemental oxygen therapy (mean difference (MD) -6.60, 95% confidence interval (CI) -54.80 to 41.60 hours) and need for mechanical ventilation (risk ratio (RR) 0.67, 95% CI 0.08 to 5.88; risk difference (RD) -0.07, 95% CI -0.46 to 0.32). Among secondary outcomes, we found no differences in terms of initiation of oral feeding. The quality of the evidence was limited due to the imprecision of the estimates. Authors' conclusions: At present there is insufficient evidence to determine the efficacy and safety of epinephrine in the management of transient tachypnea of the newborn. © 2016 The Cochrane Collaboration. Source

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