3 rows where funder_dois = "["10.13039/501100000925"]"
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|14||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"]|
|24||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, <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"]|
|64||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"]|
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