Paediatric Clinical Research Unit

The National Children’s Research Centre (NCRC) has established a Paediatric Clinical Research Unit (PaedCRU) to promote and support high quality research in children and young people.

The PaedCRU understands the culture and motivation of paediatric investigators and is committed to strengthening and expanding the evidence-base for paediatric healthcare. Research projects include pre-clinical laboratory research, diagnostic/biobanking studies, investigator-led clinical trials of active medicinal products and clinical investigations of marketed medical devices, and health services research. The PaedCRU advocates Good Research Practice for all paediatric studies.

The PaedCRU has an established governance structure and study adoption policies. All PaedCRU studies must have ethical approval from OLCHC and regulatory approval from the Irish Medicine Board, where applicable.

Studies must be:

Funded
Scientifically Sound Protocol
Appropriate Management Plan
Potential Impact
Appropriate Ethics Approvals
Appropriate Regulatory Approvals

The PaedCRU has a dediated Clinical Director, Dr. Colm O'Donnell, a dedicated Clinical Research Project Manager, Dr. Sinéad Nally, and a part-time Clinical Data Manager, Dr. Carlos Pinto.

The PaedCRU team will provide advice and assistance on all aspects of translational clinical research, including ethical and regulatory research guidance, clinical project managemet, customising data management systems and investigator-led and industry clinical investigations (medical device) and clinical trials (medicinal products).

Once approved, studies can avail of the following expertise and facilities in the PaedCRU:

Clinical Research Project Management
Protocol Development
Database Development and Data Management
Clinical Trials Pharmacist
Medical Laboratory Scientist
Clinical Research Nurses
A Two-Bedded Clinical Research Facility (e.g., for use in medicines for children studies)
Patient Proximate Sample Preparation Space
Office and Reading Space for Clinical Researchers

Access to the translational research laboratory facilities of the NCRC are also available for approved studies, to allow biobanking, and molecular and genetic analysis of samples; this ensures the true translation from the clinic to the laboratory and back to the bedside.

We hope to encourage and promote the formal evaluation of medicines for children; ensuring that medicines for use in children are ethically researched and authorised appropriately; and improve the availability of information on the use of medicines for children. We will also ensure that we do not subject children to unnecessary clinical investigations and clinical trials (through seeking appropriate statistical advice at the protocol development phase and a thorough protocol peer review process).

EXAMPLES OF CURRENT CLINICAL STUDIES:

Paediatric Emergency Research Unit, OLCHC

A Randomised Trial of Single Dose Oral Dexamethasone versus Multi-Dose Prednisolone in the Treatment of Acute Exacerbations of Asthma in Children who attend the Emergency Department
A Randomised Trial of Intranasal Fentanyl vs. Intravenous Morphine in the Treatment of Severe Painful Sickle Cell Crises in Children who Attend the Emergency Department

Neonatology, National Maternity Hospital

Chlorohexidine versus Povidone-Iodine for Skin Antisepsis prior to Central Venous Catheter Insertion in Preterm Infants: Protocol for a Randomised Trial
Randomised Controlled Trial Comparing Prongs and Masks for Nasal Continuous Positive Airways Pressure (NCPAP) in Premature Babies with Respiratory Distress
Randomised Controlled Trial Comparing Respiratory Support via a Face Mask to Single Nasal Prong for Premature Babies at Birth
Randomised Controlled Trial Comparing Polyethylene Bags and Exothermic Mattresses to Polyethylene Bags alone for Thermoregulation of Premature Infants at Birth

Dermatology, Irish and UK Sites

The Identification of Major Susceptibilty Genes for Eczema and Food Allergy

A Randomised Controlled double-blind trial of intranasal fentanyl versus intravenous morphine in the emergency department treatment of severe painful sickle cell crises in children	Dr Ronan O’Sullivan
A Randomised controlled trial of chlorhexidine versus povidone-iodine for skin antisepsis prior to central venous catheter insertion in preterm infants: a randomised trial (the ska trial)	Dr Colm O’Donnell
Evaluating dressings for split skin graft donor	Carol Hilliard Maria Brenner Glynnis Peel
Optomising the use of Mitomicin C in subglottic stenosis	Dr John Russell Dr Shay Giles Dr M Murphy
A pharmacogenomic exploration of genetic risk factors in valproate-Induced weight gain in patients with epilepsy	Dr Norman Delanty David Webb Dr G Cavalleri
Intranasal Fentanyl in the emergency department treatment of painful sickle cell crises in children	Ronan O'Sullivan