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Link rowid ▼ title DOI URL created subject references-count is-referenced-by-count ISSN container-title abstract author_number orcids names award_numbers funder_names funder_dois
14 ["Study protocol for a randomised controlled trial evaluating the effect of prenatal omega-3 LCPUFA supplementation to reduce the incidence of preterm birth: the ORIP trial"] 10.1136/bmjopen-2017-018360 http://dx.doi.org/10.1136/bmjopen-2017-018360 2017-09-26T00:10:18Z [] 0 10 ["2044-6055", "2044-6055"] BMJ Open <jats:sec><jats:title>Introduction</jats:title><jats:p>Preterm birth accounts for more than 85% of all perinatal complications and deaths. Seventy-five per cent of early preterm births (EPTBs) occur spontaneously and without identifiable risk factors. The need for a broadly applicable, effective strategy for primary prevention is paramount. Secondary outcomes from the docosahexaenoic acid (DHA) to Optimise Mother Infant Outcome trial showed that maternal supplementation until delivery with omega-3 (ω-3) long chain polyunsaturated fatty acid (LCPUFA), predominantly as DHA, resulted in a 50% reduction in the incidence of EPTB and an increase in the incidence of post-term induction or post-term prelabour caesarean section due to extended gestation. We aim to determine the effectiveness of supplementing the maternal diet with ω-3 LCPUFA until 34 weeks’ gestation on the incidence of EPTB.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>This is a multicentre, parallel group, randomised, blinded and controlled trial. Women less than 20 weeks’ gestation with a singleton or multiple pregnancy and able to give informed consent are eligible to participate. Women will be randomised to receive high DHA fish oil capsules or control capsules without DHA. Capsules will be taken from enrolment until 34 weeks’ gestation. The primary outcome is the incidence of EPTB, defined as delivery before 34 completed weeks’ gestation. Key secondary outcomes include length of gestation, incidence of post-term induction or prelabour caesarean section and spontaneous EPTB. The target sample size is 5540 women (2770 per group), which will provide 85% power to detect an absolute reduction in the incidence of preterm birth of 1.16% (from 2.45% to 1.29%) between the DHA and control group (two sided α=0.05). The primary analysis will be based on the intention-to-treat principle.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p>Australia and New Zealand Clinical Trial Registry Num… 7 [] ["Shao J Zhou", "Karen Best", "Robert Gibson", "Andrew McPhee", "Lisa Yelland", "Julie Quinlivan", "Maria Makrides"] [] ["National Health and Medical Research Council"] ["10.13039/501100000925"]
15 ["Comparative effectiveness of treatment options for plantar heel pain: a systematic review with network meta-analysis"] 10.1136/bjsports-2017-098998 http://dx.doi.org/10.1136/bjsports-2017-098998 2019-01-21T15:05:26Z ["Physical Therapy, Sports Therapy and Rehabilitation", "Orthopedics and Sports Medicine", "General Medicine"] 62 9 ["0306-3674", "1473-0480"] British Journal of Sports Medicine <jats:sec><jats:title>Objective</jats:title><jats:p>To evaluate the comparative effectiveness of current treatment options for plantar heel pain (PHP).</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>Systematic review and network meta-analysis (NMA).</jats:p></jats:sec><jats:sec><jats:title>Data sources</jats:title><jats:p>Medline, EMBASE, CINAHL, AMED, PEDro, Cochrane Database, Web of Science and WHO Clinical Trials Platform were searched from their inception until January 2018.</jats:p></jats:sec><jats:sec><jats:title>Study selection</jats:title><jats:p>Randomised controlled trials (RCTs) of adults with PHP investigating common treatments (ie, corticosteroid injection, non-steroidal anti-inflammatory drugs, therapeutic exercise, orthoses and/or extracorporeal shockwave therapy (ESWT)) compared with each other or a no treatment, placebo/sham control.</jats:p></jats:sec><jats:sec><jats:title>Data extraction and analysis</jats:title><jats:p>Data were extracted and checked for accuracy and completeness by pairs of reviewers. Primary outcomes were pain and function. Comparative treatment effects were analysed by random effects NMA in the short term, medium term and long term. Relative ranking of treatments was assessed by surface under the cumulative ranking probabilities (0–100 scale).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Thirty-one RCTs (total n=2450 patients) were included. There was no evidence of inconsistency detected between direct and indirect treatment comparisons in the networks, but sparse data led to frequently wide CIs. Available evidence does not suggest that any of the commonly used treatments for the management of PHP are better than any other, although corticosteroid injections, alone or in combination with exercise, and ESWT were ranked most likely to be effective for the management of short-term, medium-term and long-term pain or function; placebo/sham/control appeared least likely to be effective; and exercise appeared to only be beneficial for … 8 ["http://orcid.org/0000-0002-5064-6446", "http://orcid.org/0000-0002-7703-727X", "http://orcid.org/0000-0002-7248-6703"] ["Opeyemi O Babatunde", "Amardeep Legha", "Chris Littlewood", "Linda S Chesterton", "Martin J Thomas", "Hylton B Menz", "Danielle van der Windt", "Edward Roddy"] [] ["National Health and Medical Research Council", "National Institute for Health Research"] ["10.13039/501100000925", "10.13039/501100000272"]
24 ["Protocol for the Lactoferrin Infant Feeding Trial (LIFT): a randomised trial of adding lactoferrin to the feeds of very-low birthweight babies prior to hospital discharge"] 10.1136/bmjopen-2018-023044 http://dx.doi.org/10.1136/bmjopen-2018-023044 2018-10-03T04:55:26Z ["General Medicine"] 50 5 ["2044-6055", "2044-6055"] BMJ Open <jats:sec><jats:title>Introduction</jats:title><jats:p>Very-low birthweight (VLBW, &lt;1500 g) infants comprise about 1%–1.4% of all births in high-income countries. Every year, about 3000 VLBW babies in Australia and New Zealand receive intensive care. Many die or else survive with severe brain injury, retinopathy, late-onset sepsis or necrotising enterocolitis (NEC), each of which carries substantial risk of disability.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>This trial tests whether adding bovine lactoferrin (bLF) to feeds in VLBW infants improves (1) survival to hospital discharge free from brain injury, late-onset sepsis, NEC and treated retinopathy of prematurity (primary composite end point); (2) each component of the primary composite end point and (3) time to reach full enteral feeds, number of blood transfusions, chronic lung disease and length of hospital stay. It includes a cost-effectiveness analysis of bLF in improving survival free from major morbidity, and evaluates the effect of bLF on survival and developmental outcomes at 24 to 36 months corrected gestational age.</jats:p><jats:p>This is a multicentre, two-arm, randomised trial comparing the treatment group receiving bLF added to breast milk or formula milk daily (up to 250 mg/kg/day bLF) versus the control group receiving no bLF supplementation. The intervention is administered until 34 completed weeks corrected gestation or for 2 weeks, whichever is longer, or until discharge home, if earlier. The target sample size of 1500 participants yields 85% power, at the two-sided 5% level significance, to detect a difference in proportions meeting the primary outcome assuming the true probability is 74% in controls and 80.5% in the bLF group.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>This protocol was approved by Northern Sydney Local Human Research Ethics Committee in January 2017 (Version 2.0, Reference 1003-118M) and other relevant ethics committees. The findings … 6 [] ["Andrew Martin", "Alpana Ghadge", "Paolo Manzoni", "Kei Lui", "Rebecca Brown", "William Tarnow-Mordi"] [] ["National Health and Medical Research Council"] ["10.13039/501100000925"]
40 ["Infant sleep and child mental health: a longitudinal investigation"] 10.1136/archdischild-2019-318014 http://dx.doi.org/10.1136/archdischild-2019-318014 2020-03-10T03:55:23Z ["Pediatrics, Perinatology, and Child Health"] 25 1 ["0003-9888", "1468-2044"] Archives of Disease in Childhood <jats:sec><jats:title>Objective</jats:title><jats:p>To determine whether infants with severe persistent sleep problems are at increased risk of (1) meeting diagnostic criteria for a psychiatric disorder (age 10 years), and (2) having elevated symptoms of mental health difficulties (ages 4 and 10 years), in comparison with infants with settled sleep.</jats:p></jats:sec><jats:sec><jats:title>Design and setting</jats:title><jats:p>Prospective longitudinal community cohort study—the Maternal Health Study. Mothers completed questionnaires/interviews at 15 weeks' gestation; 3, 6, 9 and 12 months post partum; and when their child turned 4 and 10 years old. Measures included parental report of infant night waking and sleep problems and child mental health (Strengths and Difficulties Questionnaire; Spence Children’s Anxiety Scale; Development and Well-being Assessment).</jats:p></jats:sec><jats:sec><jats:title>Participants</jats:title><jats:p>1460 mother-infant dyads.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>283 (19.4%) infants had persistent severe sleep problems, 817 (56.0%) had moderate/fluctuating sleep problems and 360 (24.7%) infants were settled. Infants with persistent severe sleep problems were more likely to report emotional symptoms at age 4 (adjusted odds ratio (AOR)=2.70, 95% CI 1.21 to 6.05, p=0.02), and meet diagnostic criteria for an emotional disorder at age 10 (AOR=2.37, 95% CI 1.05 to 5.36, p=0.04). Infants with persistent severe sleep problems also had elevated symptoms of separation anxiety (AOR=2.44, 95% CI 1.35 to 4.41, p&lt;0.01), fear of physical injury (AOR=2.14, 95% CI 1.09 to 4.18, p=0.03) and overall elevated anxiety (AOR=2.20, 95% CI 1.13 to 4.29, p=0.02) at age 10.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Infants with persistent severe sleep problems during the first postnatal year have an increased risk of anxiety problems and emotional disorders at age 10.</jats:p></jats:sec> 6 ["http://orcid.org/0000-0001-6477-3940"] ["Fallon Cook", "Laura J Conway", "Rebecca Giallo", "Deirdre Gartland", "Emma Sciberras", "Stephanie Brown"] ["199222", "433006", "491205"] ["National Health and Medical Research Council", "Victorian Government Operational Infrastructure Support Program"] ["10.13039/501100000925", [""]]
64 ["Mapping the use of soft systems methodology for change management in healthcare: a scoping review protocol"] 10.1136/bmjopen-2018-026028 http://dx.doi.org/10.1136/bmjopen-2018-026028 2019-04-02T07:34:20Z ["General Medicine"] 0 0 ["2044-6055", "2044-6055"] BMJ Open <jats:sec><jats:title>Introduction</jats:title><jats:p>It is notoriously challenging to implement evidence-based care and to update and improve healthcare practices. One reason for the difficulty is the complexity of healthcare and the powerful influence of context on implementation and improvement efforts. Thus, there is a need for multifaceted, flexible change methods that takes these complexities into consideration. One approach that has the potential in this regard is soft systems methodology (SSM). However, little is known about how SSM has been applied in healthcare settings, making it difficult to assess the usefulness of SSM for implementation science or improvement research. The aim of the proposed scoping review is to examine and map the use and outcomes of SSM in healthcare.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>The review will adapt the framework outlined by Arksey and O’Malley (2005). Citations will be uncovered through a comprehensive database search of the peer-reviewed literature. Two reviewers will conduct a two-stage review and selection process where the titles/abstracts are examined followed by a screening of full texts of the selected citations. Reference lists of included citations will be snowballed to identify potential additional citations. Inclusion criteria are English language, peer-reviewed empirical papers focusing on the application of SSM in a healthcare setting. Both general information about the citations and information related to the objective of the review will be extracted from the included citations and entered into a data charting form. The extracted information will be reported in diagrams and tables and summarised to present a narrative account of the literature. The proposed review will provide information on the potential for using SSM to affect change in healthcare.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>No primary data will be collected, and thus ethical permission is unnecessar… 3 ["http://orcid.org/0000-0001-6203-0676", "http://orcid.org/0000-0003-0296-4957"] ["Hanna Augustsson", "Kate Churruca", "Jeffrey Braithwaite"] [] ["National Health and Medical Research Council"] ["10.13039/501100000925"]
69 ["Cell therapy for the preterm infant: promise and practicalities"] 10.1136/archdischild-2019-317896 http://dx.doi.org/10.1136/archdischild-2019-317896 2020-04-06T21:15:32Z ["Obstetrics and Gynaecology", "Pediatrics, Perinatology, and Child Health", "General Medicine"] 0 0 ["1359-2998", "1468-2052"] Archives of Disease in Childhood - Fetal and Neonatal Edition <jats:p>Recent decades have seen the rapid progress of neonatal intensive care, and the survival rates of the most preterm infants are improving. This improvement is associated with changing patterns of morbidity and new phenotypes of bronchopulmonary dysplasia and preterm brain injury are recognised. Inflammation and immaturity are known contributors to their pathogenesis. However, a new phenomenon, the exhaustion of progenitor cells is emerging as an important factor. Current therapeutic approaches do not adequately address these new mechanisms of injury. Cell therapy, that is the use of stem and stem-like cells, with its potential to both repair and prevent injury, offers a new approach to these challenging conditions. This review will examine the rationale for cell therapy in the extremely preterm infant, the preclinical and early clinical evidence to support its use in bronchopulmonary dysplasia and preterm brain injury. Finally, it will address the challenges in translating cell therapy from the laboratory to early clinical trials.</jats:p> 5 ["http://orcid.org/0000-0001-6742-7314"] ["Elizabeth K Baker", "Susan E Jacobs", "Rebecca Lim", "Euan M Wallace", "Peter G Davis"] ["Research Training Program Scholarship"] ["University of Melbourne", "National Health and Medical Research Council"] ["10.13039/501100001782", "10.13039/501100000925"]
91 ["Dance PREEMIE, a Dance PaRticipation intervention for Extremely prEterm children with Motor Impairment at prEschool age: an Australian feasibility trial protocol"] 10.1136/bmjopen-2019-034256 http://dx.doi.org/10.1136/bmjopen-2019-034256 2020-01-27T10:04:30Z ["General Medicine"] 41 0 ["2044-6055", "2044-6055"] BMJ Open <jats:sec><jats:title>Introduction</jats:title><jats:p>Children born extremely preterm (EP: &lt;28 weeks gestation) and/or extremely low birth weight (ELBW: &lt;1000 g) are at increased risk of motor impairment compared with children born at term. Children with motor impairment have lower rates of physical activity (PA) participation compared with their typically developing peers. PA participation is an important outcome for children with motor impairment, however, there is limited evidence available to support interventions that improve PA participation in this population. The aim of this study is to assess the feasibility, including the recruitment and retention, acceptability and fidelity, of a preschool dance participation intervention for children born EP/EBLW with motor impairment called Dance PaRticipation intervention for Extremely prEterm children with Motor Impairment at prEschool age.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>This feasibility case series trial will recruit EP/ELBW children with motor impairment (n=10) from the Victorian Infant Collaborative Study 2016/2017 cohort, a prospective longitudinal cohort study. Up to 10 community-based dance teachers will be recruited and provided with physiotherapy-led training and support to facilitate the participation of EP/ELBW children in community dance classes. A mixed-methods approach (quantitative and qualitative) will be used to analyse the primary aim, to determine the feasibility of the intervention from the perspectives of families and dance teachers.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>This study is approved by the Human Research Ethics Committees of The Royal Children’s Hospital and The Royal Women’s Hospital, Melbourne. Study outcomes will be disseminated through conference presentations, peer-reviewed publications and social media.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p>ACTRN12619001266156</jats:p></jats:s… 6 ["http://orcid.org/0000-0001-5447-594X", "http://orcid.org/0000-0003-3775-9267", "http://orcid.org/0000-0003-1344-1465", "http://orcid.org/0000-0001-5474-6404", "http://orcid.org/0000-0001-5901-0455", "http://orcid.org/0000-0002-6535-661X"] ["Kate L Cameron", "Jennifer L McGinley", "Kim Allison", "Natalie A Fini", "Jeanie L Y Cheong", "Alicia J Spittle"] ["S18-021"] ["Physiotherapy Research Foundation", "National Health and Medical Research Council"] ["10.13039/501100008305", "10.13039/501100000925"]

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