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Outputs (55)

Development of an Early Warning Track and Trigger system for preterm or low-birth weight infants in a low resource setting: results of a mixed-methods study at a national referral hospital in Kenya (2020)
Journal Article
Mitchell, E., Qureshi, Z., Were, F., Daniels, J., Gwako, G., Osoti, A., Opira, J., Bradshaw, L., Oliver, M., Pallotti, P., & Ojha, S. (2020). Development of an Early Warning Track and Trigger system for preterm or low-birth weight infants in a low resource setting: results of a mixed-methods study at a national referral hospital in Kenya. BMJ Global Health, 10(10), Article e039061. https://doi.org/10.1136/bmjopen-2020-039061

Introduction: Fifteen million babies are born prematurely, before 37 weeks gestational age, globally. More than 80% of these are in sub-Saharan Africa and Asia. 35% of all deaths in the first month of life are due to prematurity and the neonatal mort... Read More about Development of an Early Warning Track and Trigger system for preterm or low-birth weight infants in a low resource setting: results of a mixed-methods study at a national referral hospital in Kenya.

It is unprecedented: trial management during the COVID-19 pandemic and beyond (2020)
Journal Article
Mitchell, E. J., Ahmed, K., Breeman, S., Cotton, S., Constable, L., Ferry, G., Goodman, K., Hickey, H., Meakin, G., Mironov, K., Quann, N., Wakefield, N., & McDonald, A. (2020). It is unprecedented: trial management during the COVID-19 pandemic and beyond. Trials, 21, Article 784. https://doi.org/10.1186/s13063-020-04711-6

The COVID-19 pandemic has presented unique challenges for the clinical trial community, both in the rapid establishment of COVID-19 clinical trials and many existing non-COVID-19 studies either being temporarily paused (whether that is a complete pau... Read More about It is unprecedented: trial management during the COVID-19 pandemic and beyond.

Identifying women giving birth preterm and care at the time of birth: a prospective audit of births at six hospitals in India, Kenya, Pakistan and Uganda (2020)
Journal Article
Mitchell, E. J., Benjamin, S., Ononge, S., Ditai, J., Qureshi, Z., Masood, S. N., Whitham, D., Godolphin, P., & Duley, L. (2020). Identifying women giving birth preterm and care at the time of birth: a prospective audit of births at six hospitals in India, Kenya, Pakistan and Uganda. BMC Pregnancy and Childbirth, 20(1), Article 439. https://doi.org/10.1186/s12884-020-03126-0

Background: Globally, 15 million infants are born preterm each year, and one million die due to complications of prematurity. Over 60% of preterm births occur in Sub-Saharan Africa and south Asia. Care at birth for premature infants may be critical f... Read More about Identifying women giving birth preterm and care at the time of birth: a prospective audit of births at six hospitals in India, Kenya, Pakistan and Uganda.

Do investigator meetings improve recruitment rates in clinical trials? A retrospective before-and-after study of data from nine multi-centre clinical trials (2020)
Journal Article
Mitchell, E. J., Godolphin, P., Meakin, G., & Sprange, K. (2020). Do investigator meetings improve recruitment rates in clinical trials? A retrospective before-and-after study of data from nine multi-centre clinical trials. Trials, 21, Article 514. https://doi.org/10.1186/s13063-020-04465-1

© 2020 The Author(s). Background: Poor recruitment in clinical trials is well-documented. In large, multi-centre trials, communication between the coordinating centre and trial sites is essential. A commonly used communication tool is the hosting of... Read More about Do investigator meetings improve recruitment rates in clinical trials? A retrospective before-and-after study of data from nine multi-centre clinical trials.

Where do we go from here? – Opportunities and barriers to the career development of trial managers: a survey of UK-based trial management professionals (2020)
Journal Article
Mitchell, E., Goodman, K., Hartley, S., Hickey, H., McDonald, A. M., Meadows, H. M., Rhodes, S., Taylor, J., Wakefield, N., Farrell, B., & UK Trial Managers’ Network Executive Group. (2020). Where do we go from here? – Opportunities and barriers to the career development of trial managers: a survey of UK-based trial management professionals. Trials, 21, Article 384. https://doi.org/10.1186/s13063-020-04316-z

Background
Clinical trials commonly have a dedicated trial manager and effective trial management is essential to the successful delivery of high-quality trials. Trial managers have diverse experience and currently there is no standardised structure... Read More about Where do we go from here? – Opportunities and barriers to the career development of trial managers: a survey of UK-based trial management professionals.

Daily emollient during infancy for prevention of eczema: the BEEP randomised controlled trial (2020)
Journal Article
Chalmers, J. R., Haines, R. H., Bradshaw, L. E., Montgomery, A. A., Thomas, K. S., Brown, S. J., Ridd, M. J., Lawton, S., Simpson, E. L., Cork, M. J., Sach, T. H., Flohr, C., Mitchell, E. J., Swinden, R., Tarr, S., Davies-Jones, S., Jay, N., Kelleher, M., Perkin, M. R., Boyle, R. J., & Williams, H. C. (2020). Daily emollient during infancy for prevention of eczema: the BEEP randomised controlled trial. Lancet, 395(10228), 962-972. https://doi.org/10.1016/S0140-6736%2819%2932984-8

Background

Skin barrier dysfunction precedes eczema development. We tested whether daily use of emollient in the first year could prevent eczema in high-risk children.

Methods

We did a multicentre, pragmatic, parallel-group, randomised contr... Read More about Daily emollient during infancy for prevention of eczema: the BEEP randomised controlled trial.

Standard care informed by the result of a placental growth factor blood test versus standard care alone in women with reduced fetal movement at or after 36+0 weeks’ gestation: a pilot randomised controlled trial (2020)
Journal Article
Armstrong-Buisseret, L., Godolphin, P. J., Bradshaw, L., Mitchell, E., Ratcliffe, S., Storey, C., & Heazell, A. E. P. (2020). Standard care informed by the result of a placental growth factor blood test versus standard care alone in women with reduced fetal movement at or after 36+0 weeks’ gestation: a pilot randomised controlled trial. Pilot and Feasibility Studies, 6, Article 23. https://doi.org/10.1186/s40814-020-0561-z

Background

Biomarkers of placental function can potentially aid the diagnosis and prediction of pregnancy complications. This randomised controlled pilot trial assessed whether for women with reduced fetal movement (RFM), intervention directed by... Read More about Standard care informed by the result of a placental growth factor blood test versus standard care alone in women with reduced fetal movement at or after 36+0 weeks’ gestation: a pilot randomised controlled trial.

Randomised trial of cord clamping at very preterm birth: outcomes at 2 years (2019)
Journal Article
Armstrong-Buisseret, L., Powers, K., Dorling, J., Bradshaw, L., Johnson, S., Mitchell, E., & Duley, L. (2020). Randomised trial of cord clamping at very preterm birth: outcomes at 2 years. Archives of Disease in Childhood. Fetal and Neonatal Edition, 105(3), 292-298. https://doi.org/10.1136/archdischild-2019-316912

Objective: To report outcomes at 2 years corrected age for children of women recruited to a trial comparing alternative policies for timing of cord clamping and immediate neonatal care at very preterm birth.

Design: Parallel group randomised (1:1... Read More about Randomised trial of cord clamping at very preterm birth: outcomes at 2 years.