Research Activity North Central London Perinatal Network

Within the NCLPN there are several research studies just started or about to start in 2010 – these are listed below along with a brief summary of their status.

One of the main initiatives over the last few months has been to try to obtain funding for an increased body of staff able to cover the 3 dedicated neuroprotection cots at UCH. This follows one of the comments from the External Review in 2009, which was that UCH has to refuse approximately 1 in 3 infants referred for therapeutic hypothermia. As cooling is now standard of care for infants with moderate to severe encephalopathy, it is important that we try to resolve this.

User updates on therapeutic hypothermia are on-going; Nikki Robertson was invited to talk to parent reps at Bliss in November 2009 and will return in March 2010.

The neonatology research website is currently being updated; you will be able to read about many of these trials at

http://www.instituteforwomenshealth.ucl.ac.uk/academic_research/neonatology

Research Projects

1. Toby Xe RCT

This is a continuation of the TOBY trial; this trial is also MRC funded. The trial aims to determine whether the addition of 24 h inhaled 30% xenon to therapeutic hypothermia improves outcome further. The trial uses an MRI biomarker for assessing the surrogate outcome at 2 weeks and will be the basis for a larger phase III clinical trial in 2 years. The xenon will be delivered by a specially adapted SLE neonatal ventilator; ethics is being submitted in January 2010. The hospitals participating in this trial are: UCH, Hammersmtih Hospital and St Thomas’s Hospital.

2. Nemo Study (GOSH Ronit Pressler (lead) and UCH Janet Rennie)

A trial of optimizing anticonvulsant therapy in newborn infants with seizures. Ethics has been granted and this awaits some preliminary dosing studies.

3. MIGS study (GOSH)

Microbial Invasion and Glutamine Supplementation Study (MIGS Randomised Controlled Trial) A study to look at glutamine supplementation and microbial invasion in surgical infants on parenteral nutrition.

4. Epicure 2 follow-up Epicure 2 (run by Professor Neil Marlow and colleagues)

This study is nearing completion. Dr Huertas-Ceballos is helping with the follow-up of these infants (Bayley III developmental testing) together with Sam Johnson.

5. PIP study (Lead: Prof Kate Costeloe)

This is a trial of probiotics and involves using a single strain bifidobacillus breve BBG. The make up of the preparation is slightly complex but the intervention starts at 24-48h in all babies <31w (only exclusion is perforation!) and continues to 36 weeks. Need to send 2 stool samples first class to Mike Millar from each baby but that apart it is a simple administration and minimal data collection process. Ethics is almost complete and this study will start in 2010.

6. Quantitative MRI studies of neonatal encephalopathy

a. Defining the best biomarkers

7. Preterm imaging studies

a. Correlation of imaging at term corrected age with quantitative measures (T2 and MRS)

These studies are on-going and are very successful. A new 3T MR system will be installed at UCH in the first quarter of 2010 (jointly funded by UCH and the CRBC at UCL).