image 1ICTU runs six core therapeutic areas. However, owing to the breadth of clinical expertise at Imperial, ICTU has conducted many studies outside of these core areas in a diverse range of fields including paediatrics, neonates, gene therapy among several others, and continues to expand its areas of expertise.

Non-Core Therapeutic Areas 3 column block

Gene Therapy

ICTU has been involved in two trials evaluating gene therapy medicinal products:

1) SERCA-LVAD trial: A randomised, placebo-controlled trial of AAV1/SERCA2A in patients with advanced heart failure and a left ventricular assist device (LVAD) implanted. The trial recruited 5 patients in 1 UK site (Harefield hospital).

2) Repeated application of gene therapy in Cystic Fibrosis patients: A randomised, placebo-controlled trial to assess whether repeated doses of gene therapy administered to the lungs of CF patients can lead to clinical improvement. The trial recruited 130 patients from two UK sites.

Neonatal Medicine

Amino acid regimen and intravenous lipid composition in preterm parenteral nutrition is a randomised controlled trial of Nutritional Evaluation and Optimisation in Neonates (NEON trial):

NEON trial: A double-blind, 2x2 factorial randomised, multi-centre trial that took place in 4 London centres. The study recruited 168 preterm infants below 31 weeks gestational age. The aim of NEON was to confirm the safety and efficacy of providing parenteral (injection straight into the bloodstream, rather than the gut) nutrition as early as possible after birth. The trial is complete and published: Uthaya S, Liu X, Babalis D, Doré CJ, Warwick J, Bell J, Thomas L, Ashby D, Durighel G, Ederies A, Yanez-Lopez M, Modi N, Am J Clin Nutr. 2016 Jun;103(6):1443-52. doi: 10.3945/ajcn.115.125138. Epub 2016 Apr 20.


Mental Health

ICTU is collaborating with Dr Paul Ramchandani to coordinate the “Preventing enduring behavioural problems in young children through early psychological intervention: Healthy Start, Happy Start” study

Healthy Start, Happy Start trial: Funded by the NIHR-HTA programme and aims to recruit 300 families with infants aged 12 to 36 months.

The aim of the trial is to evaluate the effectiveness and cost-effectiveness of a video-feedback intervention to prevent enduring behavioural problems in young children. The trial recruited 300 families across a range of UK sites and is now in the follow-up phase.