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      Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial

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          Abstract

          Objective To determine if it is possible to stabilise the cerebral oxygenation of extremely preterm infants monitored by cerebral near infrared spectroscopy (NIRS) oximetry.

          Design Phase II randomised, single blinded, parallel clinical trial.

          Setting Eight tertiary neonatal intensive care units in eight European countries.

          Participants 166 extremely preterm infants born before 28 weeks of gestation: 86 were randomised to cerebral NIRS monitoring and 80 to blinded NIRS monitoring. The only exclusion criterion was a decision not to provide life support.

          Interventions Monitoring of cerebral oxygenation using NIRS in combination with a dedicated treatment guideline during the first 72 hours of life (experimental) compared with blinded NIRS oxygenation monitoring with standard care (control).

          Main outcome measures The primary outcome measure was the time spent outside the target range of 55-85% for cerebral oxygenation multiplied by the mean absolute deviation, expressed in %hours (burden of hypoxia and hyperoxia). One hour with an oxygenation of 50% gives 5%hours of hypoxia. Secondary outcomes were all cause mortality at term equivalent age and a brain injury score assessed by cerebral ultrasonography.

          Randomisation Allocation sequence 1:1 with block sizes 4 and 6 in random order concealed for the investigators. The allocation was stratified for gestational age (<26 weeks or ≥26 weeks).

          Blinding Cerebral oxygenation measurements were blinded in the control group. All outcome assessors were blinded to group allocation.

          Results The 86 infants randomised to the NIRS group had a median burden of hypoxia and hyperoxia of 36.1%hours (interquartile range 9.2-79.5%hours) compared with 81.3 (38.5-181.3) %hours in the control group, a reduction of 58% (95% confidence interval 35% to 73%, P<0.001). In the experimental group the median burden of hypoxia was 16.6 (interquartile range 5.4-68.1) %hours, compared with 53.6 (17.4-171.3) %hours in the control group (P=0.0012). The median burden of hyperoxia was similar between the groups: 1.2 (interquartile range 0.3-9.6) %hours in the experimental group compared with 1.1 (0.1-23.4) %hours in the control group (P=0.98). We found no statistically significant differences between the two groups at term corrected age. No severe adverse reactions were associated with the device.

          Conclusions Cerebral oxygenation was stabilised in extremely preterm infants using a dedicated treatment guideline in combination with cerebral NIRS monitoring.

          Trial registration ClinicalTrial.gov NCT01590316.

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          Most cited references42

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          Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials.

          To determine if inadequate approaches to randomized controlled trial design and execution are associated with evidence of bias in estimating treatment effects. An observational study in which we assessed the methodological quality of 250 controlled trials from 33 meta-analyses and then analyzed, using multiple logistic regression models, the associations between those assessments and estimated treatment effects. Meta-analyses from the Cochrane Pregnancy and Childbirth Database. The associations between estimates of treatment effects and inadequate allocation concealment, exclusions after randomization, and lack of double-blinding. Compared with trials in which authors reported adequately concealed treatment allocation, trials in which concealment was either inadequate or unclear (did not report or incompletely reported a concealment approach) yielded larger estimates of treatment effects (P < .001). Odds ratios were exaggerated by 41% for inadequately concealed trials and by 30% for unclearly concealed trials (adjusted for other aspects of quality). Trials in which participants had been excluded after randomization did not yield larger estimates of effects, but that lack of association may be due to incomplete reporting. Trials that were not double-blind also yielded larger estimates of effects (P = .01), with odds ratios being exaggerated by 17%. This study provides empirical evidence that inadequate methodological approaches in controlled trials, particularly those representing poor allocation concealment, are associated with bias. Readers of trial reports should be wary of these pitfalls, and investigators must improve their design, execution, and reporting of trials.
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            Early CPAP versus surfactant in extremely preterm infants.

            There are limited data to inform the choice between early treatment with continuous positive airway pressure (CPAP) and early surfactant treatment as the initial support for extremely-low-birth-weight infants. We performed a randomized, multicenter trial, with a 2-by-2 factorial design, involving infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation. Infants were randomly assigned to intubation and surfactant treatment (within 1 hour after birth) or to CPAP treatment initiated in the delivery room, with subsequent use of a protocol-driven limited ventilation strategy. Infants were also randomly assigned to one of two target ranges of oxygen saturation. The primary outcome was death or bronchopulmonary dysplasia as defined by the requirement for supplemental oxygen at 36 weeks (with an attempt at withdrawal of supplemental oxygen in neonates who were receiving less than 30% oxygen). A total of 1316 infants were enrolled in the study. The rates of the primary outcome did not differ significantly between the CPAP group and the surfactant group (47.8% and 51.0%, respectively; relative risk with CPAP, 0.95; 95% confidence interval [CI], 0.85 to 1.05) after adjustment for gestational age, center, and familial clustering. The results were similar when bronchopulmonary dysplasia was defined according to the need for any supplemental oxygen at 36 weeks (rates of primary outcome, 48.7% and 54.1%, respectively; relative risk with CPAP, 0.91; 95% CI, 0.83 to 1.01). Infants who received CPAP treatment, as compared with infants who received surfactant treatment, less frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia (P<0.001), required fewer days of mechanical ventilation (P=0.03), and were more likely to be alive and free from the need for mechanical ventilation by day 7 (P=0.01). The rates of other adverse neonatal outcomes did not differ significantly between the two groups. The results of this study support consideration of CPAP as an alternative to intubation and surfactant in preterm infants. (ClinicalTrials.gov number, NCT00233324.) 2010 Massachusetts Medical Society
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              Necrotizing enterocolitis: treatment based on staging criteria.

              Neonatal necrotizing enterocolitis is the most important cause of acquired gastrointestinal morbidity or mortality among low birthweight infants. Prematurity alone is probably the only identifiable risk factor. Although the etiology is unknown NEC has many similarities to an infectious disease. Proper staging helps improve reporting and the management of NEC.
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                Author and article information

                Contributors
                Role: research fellow
                Role: associate professor
                Role: research fellow
                Role: consultant neonatologist
                Role: professor of Neonatology
                Role: consultant neonatologist
                Role: professor
                Role: professor
                Role: associate professor
                Role: consultant neonatologist
                Role: head of department
                Role: trial manager
                Role: consultant neonatologist
                Role: consultant neonatologist
                Role: managing director
                Role: associate professor
                Role: research fellow
                Role: biomedical engineer
                Role: consultant neonatologist
                Role: senior researcher
                Role: professor
                Role: professor
                Journal
                BMJ
                BMJ
                bmj
                BMJ : British Medical Journal
                BMJ Publishing Group Ltd.
                0959-8138
                1756-1833
                2015
                5 January 2015
                : 350
                : g7635
                Affiliations
                [1 ]Department of Neonatology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen, Denmark
                [2 ]Department of Neonatology, La Paz University Hospital, Madrid, Spain
                [3 ]University Medical Center Utrecht, Wilhelmina Children’s Hospital, Utrecht, Netherlands
                [4 ]Rosie Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
                [5 ]Centre of the Developing Brain, King’s College London, London, UK
                [6 ]Department of Neonatology, Hopital Femme Mere Enfants, Bron, France
                [7 ]Department of Paediatrics and Child Health, University College Cork, Cork, Republic of Ireland
                [8 ]Department of Neonatology, University Children’s Hospital Tübingen, Tübingen, Germany
                [9 ]NICU, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy
                [10 ]Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
                [11 ]Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
                [12 ]Division of Neonatology, University of Zurich, Zurich, Switzerland
                [13 ]Haemoscan, Groningen, Netherlands
                [14 ]Department of Pediatrics, Medical University of Graz, Graz, Austria
                [15 ]Center for Biomedical Technology, Technical University of Madrid, Madrid, Spain
                [16 ]Biomedical Optics Research Laboratory, Division of Neonatology, University Hospital Zurich, Zurich, Switzerland
                Author notes
                Correspondence to: S Hyttel-Sorensen simonhyttelsrensen@gmail.com
                Article
                hyts021781
                10.1136/bmj.g7635
                4283997
                25569128
                991d015e-04f7-4e40-9f11-ad99a8a45d6b
                © Hyttel-Sorensen et al 2015

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 21 November 2014
                Categories
                Research

                Medicine
                Medicine

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