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Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement (2019)
Journal Article
Juszczak, E., Altman, D. G., Hopewell, S., & Schulz, K. (2019). Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement. Journal of the American Medical Association, 321(16), 1610-1620. https://doi.org/10.1001/jama.2019.3087

© 2019 AMA. All rights reserved. Importance: The quality of reporting of randomized clinical trials is suboptimal. In an era in which the need for greater research transparency is paramount, inadequate reporting hinders assessment of the reliability... Read More about Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement.

Safety and efficacy of 2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheter insertion in preterm neonates: the ARCTIC randomised-controlled feasibility trial protocol (2019)
Journal Article
Clarke, P., Craig, J. V., Wain, J., Tremlett, C., Linsell, L., Bowler, U., …Heath, P. T. (2019). Safety and efficacy of 2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheter insertion in preterm neonates: the ARCTIC randomised-controlled feasibility trial protocol. BMJ Open, 9(2), Article e028022. https://doi.org/10.1136/bmjopen-2018-028022

Introduction Catheter-related sepsis is one of the most dangerous complications of neonatal intensive care and is associated with significant morbidity and mortality. Use of catheter-care ‘bundles’ has reduced the incidence of catheter-related seps... Read More about Safety and efficacy of 2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheter insertion in preterm neonates: the ARCTIC randomised-controlled feasibility trial protocol.

Planned delivery or expectant management for late preterm pre-eclampsia: Study protocol for a randomised controlled trial (PHOENIX trial) (2019)
Journal Article
Chappell, L. C., Green, M., Marlow, N., Sandall, J., Hunter, R., Robson, S., …Shennan, A. (2019). Planned delivery or expectant management for late preterm pre-eclampsia: Study protocol for a randomised controlled trial (PHOENIX trial). Trials, 20(1), Article 85. https://doi.org/10.1186/s13063-018-3150-1

Background: Pre-eclampsia is a pregnancy disorder, characterised by hypertension and multisystem complications in the mother. The adverse outcomes of pre-eclampsia include severe hypertension, stroke, renal and hepatic injury, haemorrhage, fetal grow... Read More about Planned delivery or expectant management for late preterm pre-eclampsia: Study protocol for a randomised controlled trial (PHOENIX trial).

Enteral lactoferrin supplementation for very preterm infants: a randomised placebo-controlled trial (2019)
Journal Article
Griffiths, J., Jenkins, P., Vargova, M., Bowler, U., Juszczak, E., King, A., …Manjunatha, C. (2019). Enteral lactoferrin supplementation for very preterm infants: a randomised placebo-controlled trial. Lancet, 393(10170), 423-433. https://doi.org/10.1016/s0140-6736%2818%2932221-9

© 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license Background: Infections acquired in hospital are an important cause of morbidity and mortality in very preterm infants. Several small tri... Read More about Enteral lactoferrin supplementation for very preterm infants: a randomised placebo-controlled trial.

Analgesic efficacy and safety of morphine in the Procedural Pain in Premature Infants (Poppi) study: randomised placebo-controlled trial (2018)
Journal Article
Hartley, C., Moultrie, F., Hoskin, A., Green, G., Monk, V., Bell, J. L., …Slater, R. (2018). Analgesic efficacy and safety of morphine in the Procedural Pain in Premature Infants (Poppi) study: randomised placebo-controlled trial. Lancet, 392(10164), 2595-2605. https://doi.org/10.1016/S0140-6736%2818%2931813-0

Background: Infant pain has immediate and long-term effects but is undertreated because of a paucity of evidence-based analgesics. Although morphine is often used to sedate ventilated infants, its analgesic efficacy is unclear. We aimed to establish... Read More about Analgesic efficacy and safety of morphine in the Procedural Pain in Premature Infants (Poppi) study: randomised placebo-controlled trial.

Pulse Oximeter Saturation Targeting and Oximeter Changes in the Benefits of Oxygen Saturation Targeting (BOOST)-II Australia and BOOST-II UK Oxygen Trials (2018)
Journal Article
Stenson, B. J., Donoghoe, M., Brocklehurst, P., Davis, P. G., Juszczak, E., Marschner, I. C., …Tarnow-Mordi, W. O. (2019). Pulse Oximeter Saturation Targeting and Oximeter Changes in the Benefits of Oxygen Saturation Targeting (BOOST)-II Australia and BOOST-II UK Oxygen Trials. Journal of Pediatrics, 204, 301-304.E2. https://doi.org/10.1016/j.jpeds.2018.08.033

Infants in the Australian and UK Benefits of Oxygen Saturation Targeting-II trials treated using revised oximeters spent more time within their planned pulse oximeter saturation target ranges than infants treated using the original oximeters (P 

Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration (2018)
Journal Article
Askie, L. M., Darlow, B. A., Finer, N., Schmidt, B., Stenson, B., Tarnow-Mordi, W., …for the Neonatal Oxygenation Prospective Meta-analysis (NeOProM) Collaboration. (2018). Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. Journal of the American Medical Association, 319(21), 2190–2201. https://doi.org/10.1001/jama.2018.5725

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 asmeasured b... Read More about Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration.

Guidelines for the Content of Statistical Analysis Plans in Clinical Trials (2017)
Journal Article
Gamble, C., Krishan, A., Stocken, D., Lewis, S., Juszczak, E., Doré, C., …Loder, E. (2017). Guidelines for the Content of Statistical Analysis Plans in Clinical Trials. Journal of the American Medical Association, 318(23), 2337-2343. https://doi.org/10.1001/jama.2017.18556

© 2017 American Medical Association. All rights reserved. IMPORTANCE While guidance on statistical principles for clinical trials exists, there is an absence of guidance covering the required content of statistical analysis plans (SAPs) to support tr... Read More about Guidelines for the Content of Statistical Analysis Plans in Clinical Trials.

A multicentre, randomised controlled trial of position during the late stages of labour in nulliparous women with an epidural: Clinical effectiveness and an economic evaluation (BUMPES) (2017)
Journal Article
Bick, D., Briley, A., Brocklehurst, P., Hardy, P., Juszczak, E., Lynch, L., …Wilson, M. (2017). A multicentre, randomised controlled trial of position during the late stages of labour in nulliparous women with an epidural: Clinical effectiveness and an economic evaluation (BUMPES). Health Technology Assessment, 21(65), 1-175. https://doi.org/10.3310/hta21650

Background: Epidural analgesia leads to increased risk of instrumental vaginal delivery (IVD). There is debate about whether or not posture in second-stage labour influences the incidence of spontaneous vaginal birth (SVB). Objectives: In nulliparous... Read More about A multicentre, randomised controlled trial of position during the late stages of labour in nulliparous women with an epidural: Clinical effectiveness and an economic evaluation (BUMPES).

Computerised interpretation of fetal heart rate during labour (INFANT): a randomised controlled trial (2017)
Journal Article
Brocklehurst, P., Field, D., Greene, K., Juszczak, E., Keith, R., Kenyon, S., …Steer, P. (2017). Computerised interpretation of fetal heart rate during labour (INFANT): a randomised controlled trial. Lancet, 389(10080), 1719-1729. https://doi.org/10.1016/s0140-6736%2817%2930568-8

© 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license Background Continuous electronic fetal heart-rate monitoring is widely used during labour, and computerised interpretation could increase its usef... Read More about Computerised interpretation of fetal heart rate during labour (INFANT): a randomised controlled trial.

Bifidobacterium breve BBG-001 in very preterm infants: a randomised controlled phase 3 trial (2015)
Journal Article
Costeloe, K., Hardy, P., Juszczak, E., Wilks, M., & Millar, M. R. (2016). Bifidobacterium breve BBG-001 in very preterm infants: a randomised controlled phase 3 trial. Lancet, 387(10019), 649-660. https://doi.org/10.1016/s0140-6736%2815%2901027-2

© 2016 Elsevier Ltd. Summary Background Probiotics may reduce necrotising enterocolitis and late-onset sepsis after preterm birth. However, there has been concern about the rigour and generalisability of some trials and there is no agreement about wh... Read More about Bifidobacterium breve BBG-001 in very preterm infants: a randomised controlled phase 3 trial.

Effects of Hypothermia for Perinatal Asphyxia on Childhood Outcomes (2014)
Journal Article
Azzopardi, D., Strohm, B., Marlow, N., Brocklehurst, P., Deierl, A., Eddama, O., …Edwards, A. D. (2014). Effects of Hypothermia for Perinatal Asphyxia on Childhood Outcomes. New England Journal of Medicine, 371(2), 140-149. https://doi.org/10.1056/nejmoa1315788

BACKGROUND: In the Total Body Hypothermia for Neonatal Encephalopathy Trial (TOBY), newborns with asphyxial encephalopathy who received hypothermic therapy had improved neurologic outcomes at 18 months of age, but it is uncertain whether such therapy... Read More about Effects of Hypothermia for Perinatal Asphyxia on Childhood Outcomes.