Neonatal Research

Our neonatal unit is committed to clinical research and has an active research programme. We believe that we must do research to help the babies and their families. As doctors and nurses caring for these babies, we are continually involved in research because we want to learn how we and others can improve the way we care for babies and increase their chances of healthy survival.

Recent major studies on our NICU

Our NICU is involved in commercial (industry-sponsored) and non-commercial clinical research studies. The best and most important studies get adopted onto the National Institute for Health Research portfolio. Some of the major neonatal research studies that our unit has participated in over recent years are:

• PROGRAMS: A multicentre, single-blind, randomised, controlled trial of Prophylactic Granulocyte Macrophage colony stimulating factor (GM-CSF) to reduce sepsis in preterm neonates
  Preterm Prebiotics Study: A Randomized, Double-Blind, Controlled Trial of the Effect of Prebiotic Oligosaccharides on Enteral Tolerance in Preterm Infants
• Planet 1: A Prospective, observational study of outcomes in neonates with severe thrombocytopenia.
• TOBY : Whole Body Hypothermia for the Treatment of Perinatal Asphyxial Encephalopathy.
• ADEPT: Antenatal Doppler Enteral Prescription Trial
• MAB N007: A Phase 2b/3, Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for the Prevention of Staphylococcal Sepsis

From 2009-11 our neonatal unit was the lead UK site for the MAB N007 study. Of the eight participating UK sites, our NICU recruited the highest number of babies to this study.

Forthcoming major studies for our NICU

Some major research studies which our unit is planning to join in the near future are:

Planet 2: A randomised controlled trial to compare two different platelet count thresholds for prophylactic platelet transfusion to preterm neonates.
PUNS (Prems Under New Schedule): A phase IV study to evaluate the primary and booster immune responses of UK preterm infants receiving licensed DTaP/Hib/IPV and meningococcal C conjugate vaccines and incorporating a randomisation study of a 3 dose accelerated versus a 2 dose and a 3 dose extended schedule of a 13-valent pneumococcal conjugate vaccine for primary immunisation.).
BSSL study: A Prospective, Randomized, Double-Blind, Phase 3 Study Comparing rhBSSL and Placebo Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants Born Before Week 32 of Gestational Age.
Neomero2 – Meropenem in neonatal meningitis.

In addition to our involvement in these large studies, the doctors and nurses of the NICU are involved in a number of smaller ‘home grown’ studies that can also produce important research findings.

Our Neonatal Intensive Care Unit (NICU) enjoys close research links with academics at the University of East Anglia, and with colleagues in other regional and national neonatal units. A number of exciting collaborative clinical research projects are currently being planned.

Research funding

A dedicated neonatal unit research fund was set up to support our local neonatal research projects and to assist the dissemination of our study findings to colleagues. Our ‘Neonatal Unit Research Fund’ provides some support towards the expenses of our junior doctors when they travel to the major national and international scientific meetings to present our NICU’s research findings.

Research publications

It is important that the results from our research studies and collaborations are shared with colleagues nationally and internationally. This is done at several major paediatric/ neonatal conferences. Subsequently, following peer review, the results of the research studies get published in medical journals.

a) Important peer-reviewed publications arising from major research studies in which our neonatal unit actively collaborated:

1. Modi N, Uthaya S, Fell J, Kulinskaya E. A randomized, double-blind, controlled trial of the effect of prebiotic oligosaccharides on enteral tolerance in preterm infants (ISRCTN77444690). Pediatric Research 2010; 68: 440-5.

2. Carr R, Brocklehurst P, Doré CJ, Modi N. Granulocyte-macrophage colony stimulating factor administered as prophylaxis for reduction of sepsis in extremely preterm, small for gestational age neonates (the PROGRAMS trial): a single-blind, multicentre, randomised controlled trial. Lancet 2009; 17; 373(9659): 226-33.

3. Stanworth SJ, CLARKE P, Watts T, Ballard S, Choo L, Morris T, Murphy MF, Roberts I; Platelets and Neonatal Transfusion Study Group. Prospective, observational study of outcomes in neonates with severe thrombocytopenia. Pediatrics 2009; 124: e826-34.

4. Azzopardi DV, Strohm B, Edwards AD, Dyet L, Halliday HL, Juszczak E, Kapellou O, Levene M, Marlow N, Porter E, Thoresen M, Whitelaw A, Brocklehurst P; TOBY Study Group. Moderate hypothermia to treat perinatal asphyxial encephalopathy. New England Journal of Medicine 2009; 361: 1349-58.

5. van Kaam AH, Rimensberger PC, Borensztajn D, De Jaegere AP; Neovent Study Group. Ventilation practices in the neonatal intensive care unit: a cross-sectional study. Journal of Pediatrics 2010; 157: 767-71.

b) Selected peer-reviewed publications arising from our own unit’s neonatal research and collaborative regional studies (local researchers/co-authors are highlighted):

1. CLARKE P, BOOTH D. Copying medical summaries on deceased infants to bereaved parents. [Original Article]. Acta Paediatrica 2011: in press [Epub ahead of print 2011 Mar 19].

2. SHASTRI AT, CLARKE P, ROY R. Pulse oximetry screening for detection of critical congenital heart disease in newborns: a survey of current practices in the United Kingdom. [Research Letter]. Acta Paediatrica 2011; 100: 636-7.

3. BOSE J, CLARKE P. Use of tissue plasminogen activator to treat intracardiac thrombosis in extremely preterm infants. [Case Report/ Review] Pediatric Critical Care Medicine 2010: In press. [Epub ahead of print 2010 Dec 2.]

4. Venkatesh V, PONNUSAMY V, Anandaraj J, Chaudhary R, Malviya M, CLARKE P, Arasu A, Curley A. Endotracheal intubation in a neonatal population remains associated with a high risk of adverse events. [Original Article] European Journal of Pediatrics 2011; 170:223-7.

5. Harrington DJ, CLARKE P, Card DJ, Mitchell SJ, Shearer MJ. Urinary excretion of vitamin K metabolites in term and preterm infants: relationship to vitamin K status and prophylaxis. [Original Article] Pediatric Research 2010; [Epub ahead of print 2010 Sep 1.]

6. NATH P, PONNUSAMY V, Willis K, Bissett L, CLARKE P. Current practices of high and low flow oxygen therapy and humidification in UK neonatal units. [Letter – original] Pediatrics International 2010: 52: 893-4.

7. ALAM J, AHLUND S, THALANGE NKS, CLARKE P. The disparate psychological and social support available for parents in UK tertiary-level neonatal units [Letter – original]. Archives of Disease in Childhood Fetal & Neonatal Edition 2010; 95: 462.

8. PONNUSAMY V, NATH P, Bissett L, Willis K, CLARKE P. Current availability of cerebral function monitoring and hypothermia therapy in UK neonatal units [Letter – original]. Archives of Disease in Childhood Fetal & Neonatal Edition 2010; 95: 383-4.

9. CLARKE P. Vitamin K prophylaxis for preterm infants [Review]. Early Human Development 2010; 86: S17-20.

10. PAI JR, TREMLETT CH, CLARKE P. Late-onset sepsis in a preterm twin may harbinger life-threatening sepsis for the asymptomatic co-twin. [Brief Report] The Pediatric Infectious Disease Journal 2010; 29: 381-2.

11. PONNUSAMY V, BEACH RC, BLAKE J, CLARKE P. A case of near-drowning; a case for routine cerebral monitoring. [Clinical Observation] Acta Paediatrica 2010; 99: 463-6.

12. ÅHLUND SE, CLARKE P, HILL J, THALANGE NKS. Post-traumatic stress symptoms in mothers of very low birth weight infants 2-3 years post-partum. [Brief Report] Archives of Women’s Mental Health. 2009; 12: 261-4

13. CHAUDHARY R, Chonat S, GOWDA H, CLARKE P, Curley A. Use of premedication for intubation in tertiary neonatal units in the United Kingdom. [Original article] Pediatric Anaesthesia 2009; 19: 653-8.

14. KUMAR DATTA M, CLARKE P. Current skin antisepsis for central venous catheterisation in UK tertiary-level neonatal units. [Letter] Archives of Disease in Childhood Fetal & Neonatal Edition 2008; 93: F328.

15. CHAUDHARY R, CLARKE P. Current transfusion practices for platelets and fresh, frozen plasma in UK tertiary level neonatal units. [Letter] Acta Paediatrica 2008; 97: 135.

16. CLARKE P, Shearer MJ. Vitamin K deficiency bleeding: the readiness is all. [Perspective]. Archives of Disease in Childhood 2007; 92: 741-3.

17. CLARKE P, Shearer MJ. Vitamin K deficiency bleeding after missed prophylaxis: rapid synergistic effect of vitamin K therapy on hemostasis. [Letter] Southern Medical Journal. 2007; 100: 612-13.