May 31st 2013

Dear Fellow Colleagues

The DIN Project: Down syndrome In Neonatal units.

(Research Ethics Committee reference: 13/SC/0124)

I am writing to all lead neonatal clinicians who are members of the UK Neonatal Collaborative to invite participation in this national research study, conducted in collaboration with Professor Joan Morris, Director of the National Down Syndrome Cytogenetic Register (NDSCR) and Professor Neena Modi, at the Neonatal Data Analysis Unit (NDAU), Imperial College London.

We are asking for your agreement to extract information from the National Neonatal Research Database on babies with Down Syndrome admitted to your neonatal unit over the period 01/01/2009 to 31/12/2011, and a control set of 5 “unaffected” babies matched on gestational age in completed weeks, neonatal unit and month of admission. You will not be required to provide any additional information or obtain R&D site approval for this project.

The data will be used to investigate if newborn babies with Down syndrome require different management strategies in neonatal units compared with unaffected babies of similar gestations and to compare their outcomes on discharge. Outcomes will be used for counselling and to plan care needs.

For more information about this project please see the attached information leaflet. We would be very happy to answer any queries you may have; please contact me at or Professor Morris at . A copy of the Research Ethics approval is also attached.

Please sign and return the attached form to Anna Springett (contact details below) by June 30th indicating whether or not you would like data from your neonatal unit to be included in this study.

Yours sincerely

Dr Nik Johnson

Consultant Paediatrician

Hinchingbrooke Hospital

Cambridgeshire

AGREEMENT

The DIN Project: Down syndrome In Neonatal units.

Research Ethics Committee reference: 13/SC/0124

/ I wish for the data from the neonatal unit named below to be included in the above study.
/ I DO NOT wish for the data from the neonatal unit named below to be included in the above study

Name of Neonatal Unit

Name of NHS Trust

Name of Lead Neonatal Clinician

Signature of Lead Neonatal Clinician

Date

Authorship of publications arising from this study will be “[NAMED AUTHORS] and members of the UK Neonatal Collaborative”. As this is a study using data held in an existing database, participation does not require NHS R&D permission from Trusts contributing data, but only from the NHS Trust holding the database, Chelsea & Westminster NHS Foundation Trust.

Please return this form by post or scanned email to:

Name: Anna Springett

Address: Centre of Environmental and Preventive Medicine, Wolfson Institute of Preventive Medicine, Queen Mary University of London, Charterhouse Square,London, EC1M 6BQ

Email: Tel: 02078826249