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1.
Eur J Pediatr ; 181(12): 4215-4220, 2022 Dec.
Article in English | MEDLINE | ID: mdl-36194256

ABSTRACT

Umbilical cord milking improves postnatal adaptation and short-term outcomes of very preterm infants compared to early cord clamping. Little is known about the impact of umbilical cord milking on long-term neurodevelopmental outcomes. The objective of this study is to compare the effects of intact umbilical cord milking (UCM) vs. early cord clamping (ECC) at birth on neurodevelopmental outcomes at 36 months' corrected age. Preterm infants < 31 weeks' gestation who were randomized at birth to receive three time milking of their attached cord or ECC (< 10 s) were evaluated at 36 months' corrected age. Neurodevelopmental outcomes were assessed by blinded examiners using Bayley Scales of Infant and Toddler Development (version III). Analysis was by intention to treat. Out of the 73 infants included in the original trial, 2 died and 65 (92%) infants were evaluated at 36 months' corrected age. Patient characteristics and short-term outcomes were similar in both study groups. There were no significant differences in the median cognitive, motor or language scores or in the rates of cerebral palsy, developmental impairment, deafness, or blindness between study groups. CONCLUSION: Neurodevelopmental outcomes at 36 months' corrected age of very preterm infants who received UCM were not shown to be significantly different from those who received ECC at birth. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01487187 What is Known: • Compared to early cord clamping, umbilical cord milking improves postnatal adaptation and short-term outcomes of very preterm infants compared to early cord clamping. • Little is known about the impact of umbilical cord milking on neurodevelopmental outcomes. WHAT IS NEW: • Neurodevelopmental outcomes at 3 years of age were not significantly different in very preterm infants who received cord milking vs. those who received early cord clamping at birth.


Subject(s)
Infant, Premature, Diseases , Infant, Premature , Infant , Female , Infant, Newborn , Humans , Umbilical Cord , Constriction , Infant, Very Low Birth Weight , Fetal Growth Retardation
2.
Am J Respir Crit Care Med ; 204(10): 1192-1199, 2021 11 15.
Article in English | MEDLINE | ID: mdl-34428130

ABSTRACT

Rationale: Bronchopulmonary dysplasia increases the risk of disability in extremely preterm infants. Although the pathophysiology remains uncertain, prior exposure to intermittent hypoxemia may play a role in this relationship. Objectives: To determine the association between prolonged episodes of intermittent hypoxemia and severe bronchopulmonary dysplasia. Methods: A post hoc analysis of extremely preterm infants in the Canadian Oxygen Trial who survived to 36 weeks' postmenstrual age was performed. Oxygen saturations <80% for ⩾1 minute and the proportion of time per day with hypoxemia were quantified using continuous pulse oximetry data that had been sampled every 10 seconds from within 24 hours of birth until 36 weeks' postmenstrual age. The study outcome was severe bronchopulmonary dysplasia as defined in the 2001 NIH Workshop Summary. Measurements and Main Results: Of 1,018 infants, 332 (32.6%) developed severe bronchopulmonary dysplasia. The median number of hypoxemic episodes ranged from 0.8/day (interquartile range, 0.2-1.1) to 60.2/day (interquartile range, 51.4-70.3) among the least and most affected 10% of infants. Compared with the lowest decile of exposure to hypoxemic episodes, the adjusted relative risk of severe bronchopulmonary dysplasia increased progressively from 1.72 (95% confidence interval, 1.55-1.90) at the 2nd decile to 20.40 (95% confidence interval, 12.88-32.32) at the 10th decile. Similar risk gradients were observed for time in hypoxemia. Significant differences in the rates of hypoxemia between infants with and without severe bronchopulmonary dysplasia emerged within the first week after birth. Conclusions: Prolonged intermittent hypoxemia beginning in the first week after birth was associated with an increased risk of developing severe bronchopulmonary dysplasia among extremely preterm infants. Clinical trial registered with www.isrctn.com (ISRCTN62491227) and www.clinicaltrials.gov (NCT00637169).


Subject(s)
Bronchopulmonary Dysplasia/etiology , Bronchopulmonary Dysplasia/physiopathology , Bronchopulmonary Dysplasia/therapy , Hypoxia/complications , Hypoxia/therapy , Respiratory Distress Syndrome, Newborn/complications , Respiratory Distress Syndrome, Newborn/therapy , Bronchopulmonary Dysplasia/diagnosis , Canada , Female , Humans , Infant, Extremely Premature , Infant, Newborn , Male
3.
J Perinatol ; 41(2): 263-268, 2021 02.
Article in English | MEDLINE | ID: mdl-32782323

ABSTRACT

OBJECTIVE: To compare the effect of umbilical cord milking (UCM) vs. early cord clamping (ECC) on cerebral blood flow (CBF). METHOD: Preterm infants <31 weeks' gestation were randomized to receive UCM or ECC at birth. Blood flow velocities and resistive & pulsatility indices of middle and anterior cerebral arteries were measured at 4-6 and 10-12 h after birth as an estimate of CBF. RESULTS: Randomization allocated 37 infants to UCM and 36 to ECC. Maternal and antenatal variables were similar. There were no significant differences between groups in middle or anterior CBF velocities and resistive indices at either study time point. CBF variables were not correlated with mean blood pressure, systemic blood flow, or intraventricular hemorrhage. CONCLUSIONS: In very preterm infants, UCM compared with ECC was not shown to change CBF indices during the first 12 h of age or correlate with other hemodynamic measures or with intraventricular hemorrhage. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01487187.


Subject(s)
Infant, Premature, Diseases , Infant, Premature , Cerebrovascular Circulation , Constriction , Female , Humans , Infant , Infant, Newborn , Pregnancy , Umbilical Cord
4.
N Engl J Med ; 383(27): 2639-2651, 2020 12 31.
Article in English | MEDLINE | ID: mdl-33382931

ABSTRACT

BACKGROUND: Limited data suggest that higher hemoglobin thresholds for red-cell transfusions may reduce the risk of cognitive delay among extremely-low-birth-weight infants with anemia. METHODS: We performed an open, multicenter trial in which infants with a birth weight of 1000 g or less and a gestational age between 22 weeks 0 days and 28 weeks 6 days were randomly assigned within 48 hours after delivery to receive red-cell transfusions at higher or lower hemoglobin thresholds until 36 weeks of postmenstrual age or discharge, whichever occurred first. The primary outcome was a composite of death or neurodevelopmental impairment (cognitive delay, cerebral palsy, or hearing or vision loss) at 22 to 26 months of age, corrected for prematurity. RESULTS: A total of 1824 infants (mean birth weight, 756 g; mean gestational age, 25.9 weeks) underwent randomization. There was a between-group difference of 1.9 g per deciliter (19 g per liter) in the pretransfusion mean hemoglobin levels throughout the treatment period. Primary outcome data were available for 1692 infants (92.8%). Of 845 infants in the higher-threshold group, 423 (50.1%) died or survived with neurodevelopmental impairment, as compared with 422 of 847 infants (49.8%) in the lower-threshold group (relative risk adjusted for birth-weight stratum and center, 1.00; 95% confidence interval [CI], 0.92 to 1.10; P = 0.93). At 2 years, the higher- and lower-threshold groups had similar incidences of death (16.2% and 15.0%, respectively) and neurodevelopmental impairment (39.6% and 40.3%, respectively). At discharge from the hospital, the incidences of survival without severe complications were 28.5% and 30.9%, respectively. Serious adverse events occurred in 22.7% and 21.7%, respectively. CONCLUSIONS: In extremely-low-birth-weight infants, a higher hemoglobin threshold for red-cell transfusion did not improve survival without neurodevelopmental impairment at 22 to 26 months of age, corrected for prematurity. (Funded by the National Heart, Lung, and Blood Institute and others; TOP ClinicalTrials.gov number, NCT01702805.).


Subject(s)
Anemia/therapy , Erythrocyte Transfusion , Hemoglobins/analysis , Infant, Extremely Low Birth Weight/blood , Infant, Extremely Premature/blood , Infant, Premature, Diseases/therapy , Neurodevelopmental Disorders/prevention & control , Algorithms , Anemia/blood , Anemia/mortality , Cerebral Palsy/prevention & control , Cognition Disorders/prevention & control , Erythrocyte Transfusion/adverse effects , Hearing Loss/prevention & control , Humans , Infant, Newborn/blood , Infant, Premature/blood , Infant, Premature, Diseases/blood , Infant, Premature, Diseases/mortality , Survival Rate , Vision Disorders/prevention & control
5.
Semin Fetal Neonatal Med ; 25(2): 101080, 2020 04.
Article in English | MEDLINE | ID: mdl-31983671

ABSTRACT

The Neonatal Oxygenation Prospective Meta-analysis combined the individual participant data of 4965 extremely preterm infants. They had been randomly assigned in 5 trials to arterial oxygen saturations of 85%-89% or 91%-95% using modified oximeters to mask the treatment allocation. The primary outcome of death or disability did not differ significantly between the groups. Assignment to the higher target range reduced the risks of death and severe necrotizing enterocolitis but increased the risk of treated retinopathy. Trade-offs between the benefits and risks of higher or lower saturation targets should be informed by the local patient risks and institutional rates for outcomes that may be affected by a policy change. Features of the oximeter masking algorithm introduced unanticipated artifacts into the saturation display that are not seen in routine care. NeOProM provides little guidance on where to set the oximeter alarms and how to respond to them.


Subject(s)
Intensive Care Units, Neonatal , Oximetry , Oxygen Inhalation Therapy , Oxygen/metabolism , Humans , Infant , Infant, Extremely Premature , Infant, Newborn , Intensive Care Units, Neonatal/standards , Oximetry/methods , Oximetry/standards , Oxygen/analysis , Oxygen Inhalation Therapy/methods , Oxygen Inhalation Therapy/standards , Prospective Studies , Reference Values
6.
Neonatology ; 115(4): 406-410, 2019.
Article in English | MEDLINE | ID: mdl-30974429

ABSTRACT

Currently the question of whether to maintain a higher hemoglobin level by transfusing more liberally, as opposed to a more restrictive strategy with lower hemoglobin maintenance levels, has not been answered. We review summarized conclusions of a Cochrane systematic review and meta-analysis of 614 infants in 4 randomized controlled trials (RCT) pooling data. This suggests potential benefits of higher hemoglobin levels, i.e., a possible improved cognition of infants at 18-21 months' corrected age and a reduction of apnea. However, the data on cognition is hypothesis generating as it derives from a post hoc analysis from a single trial in 451 infants. Moreover, the data on apnea need confirmation in larger trials. The effect of adding data of cognitive 2-year outcomes of 1,744 infants from 2 RCT, which will be reported soon, should expand our understanding. This new data will need to be integrated with the older generation of RCTs but also with emerging suggestions from observational data on potential risks of blood transfusions. We discuss some of these warnings from observational studies. Finally, we ask whether we are ready to individualize blood transfusion to physiological measures made in individual infants, and we point to some current difficulties hindering this step.


Subject(s)
Anemia, Neonatal/prevention & control , Erythrocyte Transfusion/trends , Infant, Low Birth Weight/blood , Infant, Premature/blood , Anemia, Neonatal/blood , Apnea/prevention & control , Erythropoietin/adverse effects , Erythropoietin/blood , Evidence-Based Practice , Humans , Infant, Newborn , Randomized Controlled Trials as Topic , Retinopathy of Prematurity/etiology
8.
Appl Clin Inform ; 10(1): 151-157, 2019 01.
Article in English | MEDLINE | ID: mdl-30812041

ABSTRACT

OBJECTIVE: This project examined and produced a general practice (GP) based decision support tool (DST), namely POLAR Diversion, to predict a patient's risk of emergency department (ED) presentation. The tool was built using both GP/family practice and ED data, but is designed to operate on GP data alone. METHODS: GP data from 50 practices during a defined time frame were linked with three local EDs. Linked data and data mapping were used to develop a machine learning DST to determine a range of variables that, in combination, led to predictive patient ED presentation risk scores. Thirteen percent of the GP data was kept as a control group and used to validate the tool. RESULTS: The algorithm performed best in predicting the risk of attending ED within the 30-day time category, and also in the no ED attendance tests, suggesting few false positives. At 0 to 30 days the positive predictive value (PPV) was 74%, with a sensitivity/recall of 68%. Non-ED attendance had a PPV of 82% and sensitivity/recall of 96%. CONCLUSION: Findings indicate that the POLAR Diversion algorithm performed better than previously developed tools, particularly in the 0 to 30 day time category. Its utility increases because of it being based on the data within the GP system alone, with the ability to create real-time "in consultation" warnings. The tool will be deployed across GPs in Australia, allowing us to assess the clinical utility, and data quality needs in further iterations.


Subject(s)
Decision Support Techniques , Emergency Service, Hospital , General Practitioners/statistics & numerical data , Referral and Consultation , Algorithms , Electronic Health Records , Humans , Predictive Value of Tests , Risk Assessment
9.
Arch Dis Child Fetal Neonatal Ed ; 104(2): F145-F150, 2019 Mar.
Article in English | MEDLINE | ID: mdl-29903720

ABSTRACT

OBJECTIVE: To investigate whether umbilical cord milking (UCM) at birth improves systemic blood flow and short-term outcomes, as compared with immediate cord clamping (ICC). DESIGN: Randomised clinical trial. SETTING: Single tertiary care centre. PATIENTS: Infants born to eligible women presenting in preterm labour between 24 and 31 weeks' gestation. INTERVENTIONS: UCM three times at birth or ICC. OUTCOME MEASURES: Primary outcome included systemic blood flow as represented by echo-derived superior vena cava(SVC) flow at 4-6 hours after birth. The echocardiographer and interpreter were blinded to the randomisation. Secondary outcomes included cardiac output, neonatal morbidities and mortality. Analysis was by intention to treat. RESULTS: A total of 73 infants were randomised (37 to UCM and 36 to ICC). Mean (SD) gestational age was 27 (2) weeks and mean (SD) birth weight was 1040 (283) g. Haemoglobin on admission was higher in the UCM than in the ICC group (16.1 vs 15.0 g/L), p=0.049 (mean difference 1.1, 95% CI 0.003 to 2.2). No statistically significant differences were found between groups in SVC flow at 4-6 hours (88.9±37.8 and 107.3±60.1 mL/kg/min), p=0.13 (mean difference -18.4, 95% CI -41.7 to 5.0 mL/kg/min) or at 10-12 hours of age (102.5±41.8 and 90.6±28.4 mL/kg/min), p=0.17 (mean difference 12.0, 95% CI -4.7 to 28.7 mL/kg/min), cardiac output or neonatal morbidities. CONCLUSIONS: Cord milking was not shown to improve functional cardiac outcomes, neonatal morbidity or mortality. More research is needed before routine cord milking can be recommended for very preterm infants. TRIAL REGISTRATION: NCT01487187.


Subject(s)
Hemodynamics/physiology , Infant, Premature/physiology , Perinatal Care/methods , Umbilical Cord , Vena Cava, Superior/physiology , Adult , Blood Flow Velocity/physiology , Cardiac Output/physiology , Constriction , Female , Humans , Infant , Infant Mortality , Infant, Newborn
10.
BMJ Open ; 8(11): e024223, 2018 11 13.
Article in English | MEDLINE | ID: mdl-30429148

ABSTRACT

INTRODUCTION: In Australia, general practitioners usually are the first point of contact for patients with non-urgent medical conditions. Appropriate and efficient utilisation of pathology tests by general practitioners forms a key part of diagnosis and monitoring. However overutilisationand underutilisation of pathology tests have been reported across several tests and conditions, despite evidence-based guidelines outlining best practice in pathology testing. There are a limited number of studies evaluating the impact of these guidelines on pathology testing in general practice. The aim of our quantitative observational study is to define how pathology tests are used in general practice and investigate how test ordering practices align with evidence-based pathology guidelines. METHODS AND ANALYSIS: Access to non-identifiable patient data will be obtained through electronic health records from general practices across three primary health networks in Victoria, Australia. Numbers and characteristics of patients, general practices, encounters, pathology tests and problems managed over time will be described. Overall rates of encounters and tests, alongside more detailed investigation between subcategories (encounter year, patient's age, gender, and location and general practice size), will also be undertaken. To evaluate how general practitioner test ordering coincides with evidence-based guidelines, five key candidate indicators will be investigated: full blood counts for patients on clozapine medication; international normalised ratio measurements for patients on warfarin medication; glycated haemoglobin testing for monitoring patients with diabetes; vitamin D testing; and thyroid function testing. ETHICS AND DISSEMINATION: Ethics clearance to collect data from general practice facilities has been obtained by the data provider from the RACGP National Research and Evaluation Ethics Committee (NREEC 17-008). Approval for the research group to use these data has been obtained from Macquarie University (5201700872). This study is funded by the Australian Government Department of Health Quality Use of Pathology Program (Agreement ID: 4-2QFVW4M). Findings will be reported to the Department of Health and disseminated in peer-reviewed academic journals and presentations (national and international conferences, industry forums).


Subject(s)
Blood Chemical Analysis/statistics & numerical data , Electronic Health Records/statistics & numerical data , General Practice/statistics & numerical data , Guideline Adherence/statistics & numerical data , Health Services Misuse/statistics & numerical data , Pathology, Clinical/statistics & numerical data , Adult , Clozapine/adverse effects , Clozapine/therapeutic use , Diabetes Mellitus, Type 2/blood , Evaluation Studies as Topic , Glycated Hemoglobin/analysis , Humans , International Normalized Ratio , Thyroid Function Tests/statistics & numerical data , Utilization Review/statistics & numerical data , Victoria , Vitamin D/blood , Warfarin/adverse effects , Warfarin/therapeutic use
11.
JAMA ; 319(21): 2190-2201, 2018 06 05.
Article in English | MEDLINE | ID: mdl-29872859

ABSTRACT

Importance: There are potential benefits and harms of hyperoxemia and hypoxemia for extremely preterm infants receiving more vs less supplemental oxygen. Objective: To compare the effects of different target ranges for oxygen saturation as measured by pulse oximetry (Spo2) on death or major morbidity. Design, Setting, and Participants: Prospectively planned meta-analysis of individual participant data from 5 randomized clinical trials (conducted from 2005-2014) enrolling infants born before 28 weeks' gestation. Exposures: Spo2 target range that was lower (85%-89%) vs higher (91%-95%). Main Outcomes and Measures: The primary outcome was a composite of death or major disability (bilateral blindness, deafness, cerebral palsy diagnosed as ≥2 level on the Gross Motor Function Classification System, or Bayley-III cognitive or language score <85) at a corrected age of 18 to 24 months. There were 16 secondary outcomes including the components of the primary outcome and other major morbidities. Results: A total of 4965 infants were randomized (2480 to the lower Spo2 target range and 2485 to the higher Spo2 range) and had a median gestational age of 26 weeks (interquartile range, 25-27 weeks) and a mean birth weight of 832 g (SD, 190 g). The primary outcome occurred in 1191 of 2228 infants (53.5%) in the lower Spo2 target group and 1150 of 2229 infants (51.6%) in the higher Spo2 target group (risk difference, 1.7% [95% CI, -1.3% to 4.6%]; relative risk [RR], 1.04 [95% CI, 0.98 to 1.09], P = .21). Of the 16 secondary outcomes, 11 were null, 2 significantly favored the lower Spo2 target group, and 3 significantly favored the higher Spo2 target group. Death occurred in 484 of 2433 infants (19.9%) in the lower Spo2 target group and 418 of 2440 infants (17.1%) in the higher Spo2 target group (risk difference, 2.8% [95% CI, 0.6% to 5.0%]; RR, 1.17 [95% CI, 1.04 to 1.31], P = .01). Treatment for retinopathy of prematurity was administered to 220 of 2020 infants (10.9%) in the lower Spo2 target group and 308 of 2065 infants (14.9%) in the higher Spo2 target group (risk difference, -4.0% [95% CI, -6.1% to -2.0%]; RR, 0.74 [95% CI, 0.63 to 0.86], P < .001). Severe necrotizing enterocolitis occurred in 227 of 2464 infants (9.2%) in the lower Spo2 target group and 170 of 2465 infants (6.9%) in the higher Spo2 target group (risk difference, 2.3% [95% CI, 0.8% to 3.8%]; RR, 1.33 [95% CI, 1.10 to 1.61], P = .003). Conclusions and Relevance: In this prospectively planned meta-analysis of individual participant data from extremely preterm infants, there was no significant difference between a lower Spo2 target range compared with a higher Spo2 target range on the primary composite outcome of death or major disability at a corrected age of 18 to 24 months. The lower Spo2 target range was associated with a higher risk of death and necrotizing enterocolitis, but a lower risk of retinopathy of prematurity treatment.


Subject(s)
Developmental Disabilities/epidemiology , Enterocolitis, Necrotizing/epidemiology , Infant, Extremely Premature , Infant, Premature, Diseases/epidemiology , Oxygen/blood , Blindness/epidemiology , Cerebral Palsy/epidemiology , Deafness/epidemiology , Female , Humans , Incidence , Infant , Infant Mortality , Infant, Newborn , Infant, Premature, Diseases/mortality , Kaplan-Meier Estimate , Male , Oximetry , Oxygen/administration & dosage , Randomized Controlled Trials as Topic
13.
Cochrane Database Syst Rev ; 4: CD011190, 2017 04 11.
Article in English | MEDLINE | ID: mdl-28398697

ABSTRACT

BACKGROUND: The use of supplemental oxygen in the care of extremely preterm infants has been common practice since the 1940s. Despite this, there is little agreement regarding which oxygen saturation (SpO2) ranges to target to maximise short- or long-term growth and development, while minimising harms. There are two opposing concerns. Lower oxygen levels (targeting SpO2 at 90% or less) may impair neurodevelopment or result in death. Higher oxygen levels (targeting SpO2 greater than 90%) may increase severe retinopathy of prematurity or chronic lung disease.The use of pulse oximetry to non-invasively assess neonatal SpO2 levels has been widespread since the 1990s. Until recently there were no randomised controlled trials (RCTs) that had assessed whether it is better to target higher or lower oxygen saturation levels in extremely preterm infants, from birth or soon thereafter. As a result, there is significant international practice variation and uncertainty remains as to the most appropriate range to target oxygen saturation levels in preterm and low birth weight infants. OBJECTIVES: 1. What are the effects of targeting lower versus higher oxygen saturation ranges on death or major neonatal and infant morbidities, or both, in extremely preterm infants?2. Do these effects differ in different types of infants, including those born at a very early gestational age, or in those who are outborn, without antenatal corticosteroid coverage, of male sex, small for gestational age or of multiple birth, or by mode of delivery? SEARCH METHODS: We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 4), MEDLINE via PubMed (1966 to 11 April 2016), Embase (1980 to 11 April 2016) and CINAHL (1982 to 11 April 2016). We also searched clinical trials databases, conference proceedings and the reference lists of retrieved articles for randomised controlled trials. SELECTION CRITERIA: Randomised controlled trials that enrolled babies born at less than 28 weeks' gestation, at birth or soon thereafter, and targeted SpO2 ranges of either 90% or below or above 90% via pulse oximetry, with the intention of maintaining such targets for at least the first two weeks of life. DATA COLLECTION AND ANALYSIS: We used the standard methods of Cochrane Neonatal to extract data from the published reports of the included studies. We sought some additional aggregate data from the original investigators in order to align the definitions of two key outcomes. We conducted the meta-analyses with Review Manager 5 software, using the Mantel-Haenszel method for estimates of typical risk ratio (RR) and risk difference (RD) and a fixed-effect model. We assessed the included studies using the Cochrane 'Risk of bias' and GRADE criteria in order to establish the quality of the evidence. We investigated heterogeneity of effects via pre-specified subgroup and sensitivity analyses. MAIN RESULTS: Five trials, which together enrolled 4965 infants, were eligible for inclusion. The investigators of these five trials had prospectively planned to combine their data as part of the NeOProM (Neonatal Oxygen Prospective Meta-analysis) Collaboration. We graded the quality of evidence as high for the key outcomes of death, major disability, the composite of death or major disability, and necrotising enterocolitis; and as moderate for blindness and retinopathy of prematurity requiring treatment.When an aligned definition of major disability was used, there was no significant difference in the composite primary outcome of death or major disability in extremely preterm infants when targeting a lower (SpO2 85% to 89%) versus a higher (SpO2 91% to 95%) oxygen saturation range (typical RR 1.04, 95% confidence interval (CI) 0.98 to 1.10; typical RD 0.02, 95% CI -0.01 to 0.05; 5 trials, 4754 infants) (high-quality evidence). Compared with a higher target range, a lower target range significantly increased the incidence of death at 18 to 24 months corrected age (typical RR 1.16, 95% CI 1.03 to 1.31; typical RD 0.03, 95% CI 0.01 to 0.05; 5 trials, 4873 infants) (high-quality evidence) and necrotising enterocolitis (typical RR 1.24, 95% 1.05 to 1.47; typical RD 0.02, 95% CI 0.01 to 0.04; 5 trials, 4929 infants; I² = 0%) (high-quality evidence). Targeting the lower range significantly decreased the incidence of retinopathy of prematurity requiring treatment (typical RR 0.72, 95% CI 0.61 to 0.85; typical RD -0.04, 95% CI -0.06 to -0.02; 5 trials, 4089 infants; I² = 69%) (moderate-quality evidence). There were no significant differences between the two treatment groups for major disability including blindness, severe hearing loss, cerebral palsy, or other important neonatal morbidities.A subgroup analysis of major outcomes by type of oximeter calibration software (original versus revised) found a significant difference in the treatment effect between the two software types for death (interaction P = 0.03), with a significantly larger treatment effect seen for those infants using the revised algorithm (typical RR 1.38, 95% CI 1.13 to 1.68; typical RD 0.06, 95% CI 0.01 to 0.10; 3 trials, 1716 infants). There were no other important differences in treatment effect shown by the subgroup analyses using the currently available data. AUTHORS' CONCLUSIONS: In extremely preterm infants, targeting lower (85% to 89%) SpO2 compared to higher (91% to 95%) SpO2 had no significant effect on the composite outcome of death or major disability or on major disability alone, including blindness, but increased the average risk of mortality by 28 per 1000 infants treated. The trade-offs between the benefits and harms of the different oxygen saturation target ranges may need to be assessed within local settings (e.g. alarm limit settings, staffing, baseline outcome risks) when deciding on oxygen saturation targeting policies.


Subject(s)
Infant Mortality , Infant, Extremely Premature , Oxygen/administration & dosage , Oxygen/blood , Age Factors , Arteries , Blindness/epidemiology , Blindness/etiology , Cerebral Palsy/epidemiology , Enterocolitis, Necrotizing/epidemiology , Enterocolitis, Necrotizing/etiology , Humans , Incidence , Infant , Infant, Newborn , Oximetry , Oxygen/adverse effects , Publication Bias , Randomized Controlled Trials as Topic , Retinopathy of Prematurity/epidemiology , Retinopathy of Prematurity/etiology , Retinopathy of Prematurity/prevention & control , Selection Bias , Software
15.
J Pediatr ; 182: 382-384, 2017 03.
Article in English | MEDLINE | ID: mdl-28088392

ABSTRACT

It has been reported in the 3 Benefits of Oxygen Saturation Targeting (BOOST-II) trials that changes in oximeter calibration software resulted in clearer separation between the oxygen saturations in the two trial target groups. A revised analysis of the published BOOST-II data does not support this conclusion.


Subject(s)
Hypoxia/diagnosis , Infant, Premature , Oximetry/instrumentation , Oxygen Consumption/physiology , Software , Calibration , Equipment Design , Equipment Safety , Female , Humans , Infant, Newborn , Male , Oximetry/methods , Oxygen/blood , Randomized Controlled Trials as Topic , Sensitivity and Specificity
16.
J Pediatr ; 182: 375-377.e2, 2017 03.
Article in English | MEDLINE | ID: mdl-27939107

ABSTRACT

To compare pulse oximetry measurement bias between infants with hypoxemia with either dark skin or light skin with Masimo Radical 7 and Nellcor Oximax. There was no significant difference in systematic bias based on skin pigment for either oximeter.


Subject(s)
Heart Defects, Congenital/diagnosis , Hypoxia/diagnosis , Infant, Premature , Oximetry/methods , Skin Pigmentation/physiology , Critical Illness , Cross-Sectional Studies , Female , Hospitals, Pediatric , Humans , Hypoxia/blood , Infant, Newborn , Intensive Care Units, Neonatal , Male , Prospective Studies , Sensitivity and Specificity , Statistics, Nonparametric
17.
J Pediatr ; 178: 288-291.e2, 2016 Nov.
Article in English | MEDLINE | ID: mdl-27597731

ABSTRACT

Subgroup analysis of the Canadian Oxygen Trial to compare outcomes of extremely preterm infants in centers with more versus less separation between median arterial oxygen saturations in the two target ranges. Centers with more separation observed lower rates of death or disability in the 85%-89% range than in the 91%-95% target range.


Subject(s)
Infant, Extremely Premature/blood , Oximetry/methods , Oxygen/blood , Canada , Female , Humans , Infant, Newborn , Infant, Premature , Male , Oxygen Inhalation Therapy
18.
J Obstet Gynaecol Can ; 37(11): 958-65, 2015 Nov.
Article in English | MEDLINE | ID: mdl-26629716

ABSTRACT

OBJECTIVE: To develop a prediction model for neonatal mortality using information readily available in the antenatal period. METHODS: A multiple logistic regression model of a complete population-based geographically defined cohort of very preterm infants of 23+0 to 30+6 weeks' gestation was used to identify antenatal factors which were predictive of mortality in this population. Infants lt; 23 weeks and those with major anomalies were excluded. RESULTS: Between 1996 and 2012, 1240 live born infants lt; 31 weeks' gestation were born to women residing in Nova Scotia. Decreasing gestational age strongly predicted an increased mortality rate. Other factors significantly contributing to increased mortality included classification as small for gestational age, oligohydramnios, maternal psychiatric disorders, antenatal antibiotic therapy, and monochorionic twins. Reduced neonatal mortality was associated with antenatal use of antihypertensive agents and use of corticosteroids of any duration of therapy given at least 24 hours before delivery. An algorithm was developed to estimate the risk of mortality without the need for a calculator. CONCLUSION: Prediction of the probability of neonatal mortality is influenced by maternal and fetal factors. An algorithm to estimate the risk of mortality facilitates counselling and informs shared decision making regarding obstetric management.


Objectif : Élaborer un modèle prédictif en ce qui concerne la mortalité néonatale au moyen de renseignements faciles à obtenir au cours de la période prénatale. Méthodes : Nous avons eu recours au modèle de régression logistique multiple d'une cohorte exhaustive, populationnelle et définie géographiquement de nouveau-nés très prématurés (âge gestationnel : de 23+0 à 30+6 semaines) pour identifier les facteurs prénataux permettant de prédire la mortalité au sein de cette population. Les nouveau-nés dont l'âge gestationnel était inférieur à 23 semaines et ceux qui présentaient des anomalies majeures ont été exclus. Résultats : Entre 1996 et 2012, 1 240 enfants nés vivants à moins de 31 semaines de gestation ont été issus de femmes résidant en Nouvelle-Écosse. La baisse de l'âge gestationnel constituait un facteur solide permettant de prédire une hausse du taux de mortalité. Parmi les autres facteurs contribuant de façon significative à la hausse du taux de mortalité, on trouvait l'hypotrophie fœtale, l'oligohydramnios, les troubles psychiatriques maternels, l'antibiothérapie prénatale et les jumeaux monozygotes. La baisse du taux de mortalité néonatale était associée à l'utilisation prénatale d'antihypertenseurs et à l'utilisation de corticostéroïdes (peu importe la durée du traitement) administrés au moins 24 heures avant l'accouchement. Nous avons élaboré un algorithme pour estimer le risque de mortalité sans avoir recours à une calculatrice. Conclusion : La prévision de la probabilité de la mortalité néonatale est influencée par des facteurs maternels et fœtaux. Le fait de disposer d'un algorithme pour estimer le risque de mortalité facilite le counseling et éclaire le processus décisionnel partagé en ce qui concerne la prise en charge obstétricale.


Subject(s)
Infant Mortality , Infant, Premature, Diseases/mortality , Infant, Premature , Algorithms , Cohort Studies , Female , Geography , Gestational Age , Humans , Infant , Infant, Newborn , Logistic Models , Male , Nova Scotia/epidemiology , Predictive Value of Tests , Pregnancy , Prenatal Care , Risk Factors
19.
JAMA ; 314(6): 595-603, 2015 Aug 11.
Article in English | MEDLINE | ID: mdl-26262797

ABSTRACT

IMPORTANCE: Extremely preterm infants may experience intermittent hypoxemia or bradycardia for many weeks after birth. The prognosis of these events is uncertain. OBJECTIVE: To determine the association between intermittent hypoxemia or bradycardia and late death or disability. DESIGN, SETTING, AND PARTICIPANTS: Post hoc analysis of data from the inception cohort assembled for the Canadian Oxygen Trial in 25 hospitals in Canada, the United States, Argentina, Finland, Germany, and Israel, including 1019 infants with gestational ages of 23 weeks 0 days through 27 weeks 6 days who were born between December 2006 and August 2010 and survived to a postmenstrual age of 36 weeks. Follow-up assessments occurred between October 2008 and August 2012. EXPOSURES: Episodes of hypoxemia (pulse oximeter oxygen saturation <80%) or bradycardia (pulse rate <80/min) for 10 seconds or longer. Values were sampled every 10 seconds within 24 hours after birth until at least 36 weeks' postmenstrual age. MAIN OUTCOMES AND MEASURES: The primary outcome was a composite of death after 36 weeks' postmenstrual age, motor impairment, cognitive or language delay, severe hearing loss, or bilateral blindness at 18 months' corrected age. Secondary outcomes were motor impairment, cognitive or language delay, and severe retinopathy of prematurity. RESULTS: Downloaded saturation and pulse rate data were available for a median of 68.3 days (interquartile range, 56.8-86.0 days). Mean percentages of recorded time with hypoxemia for the least and most affected 10% of infants were 0.4% and 13.5%, respectively. Corresponding values for bradycardia were 0.1% and 0.3%. The primary outcome was ascertained for 972 infants and present in 414 (42.6%). Hypoxemic episodes were associated with an estimated increased risk of late death or disability at 18 months of 56.5% in the highest decile of hypoxemic exposure vs 36.9% in the lowest decile (modeled relative risk, 1.53; 95% CI, 1.21-1.94). This association was significant only for prolonged hypoxemic episodes lasting at least 1 minute (relative risk, 1.66; 95% CI, 1.35-2.05 vs for shorter episodes, relative risk, 1.01; 95% CI, 0.77-1.32). Relative risks for all secondary outcomes were similarly increased after prolonged hypoxemia. Bradycardia did not alter the prognostic value of hypoxemia. CONCLUSIONS AND RELEVANCE: Among extremely preterm infants who survived to 36 weeks' postmenstrual age, prolonged hypoxemic episodes during the first 2 to 3 months after birth were associated with adverse 18-month outcomes. If confirmed in future studies, further research on the prevention of such episodes is needed.


Subject(s)
Bradycardia , Hypoxia , Infant, Extremely Premature , Blindness , Cognition Disorders , Cohort Studies , Death , Disabled Children , Female , Gestational Age , Hearing Loss , Humans , Infant , Infant, Newborn , Language Development Disorders , Male , Motor Skills Disorders , Oxygen/blood , Retinopathy of Prematurity , Survival Analysis
20.
J Obstet Gynecol Neonatal Nurs ; 44(2): 193-202, 2015.
Article in English | MEDLINE | ID: mdl-25712585

ABSTRACT

OBJECTIVE: To evaluate the efficacy of cobedding on twin coregulation and twin safety. DESIGN: Randomized controlled trial (RCT). SETTING: Two university affiliated Level III neonatal intensive care units (NICUs). PARTICIPANTS: One hundred and seventeen sets (N = 234) of stable preterm twins (<37 weeks gestational age at birth) admitted to the NICU. METHODS: Sets of twins were randomly assigned to be cared for in a single cot (cobedded) or in separate cots (standard care). State response was obtained from videotaped and physiologic data measured and recorded for three, 3-hour sessions over a one-week study period. Tapes were coded for infant state by an assessor blind to the purpose of the study. RESULTS: Twins who were cobedded spent more time in the same state (p < .01), less time in opposite states (p < .01), were more often in quiet sleep (p < .01) and cried less (p < .01) than twins who were cared for in separate cots. There was no difference in physiological parameters between groups (p = .85). There was no difference in patient safety between groups (incidence of sepsis, p = .95), incidence of caregiver error (p = .31), and incidence of apnea (p = .70). CONCLUSIONS: Cobedding promotes self-regulation and sleep and decreases crying without apparent increased risk.


Subject(s)
Beds , Infant Behavior/psychology , Infant Care/methods , Infant, Premature/psychology , Intensive Care, Neonatal/methods , Sleep/physiology , Twins/psychology , Analysis of Variance , Child Development/physiology , Codependency, Psychological , Confidence Intervals , Female , Humans , Infant , Infant, Newborn , Intensive Care Units, Neonatal , Male , Multivariate Analysis , Patient Safety , Reference Values , Treatment Outcome
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