Clinical research studies

We currently support a number of clinical research studies, including:

  • Optiprem – aims to determine whether the type of unit in which neonatal care is delivered influences outcomes. In this three year study, national data collected on babies born at 27-31 weeks will be analysed to assess the impact of the type of unit in which neonatal care is delivered on survival and other key morbidities for these babies.
  • Neovanc – aims to compare the efficacy of an optimised vancomycin dosing regimen to a standard vancomycin dosing regimen in patients with late onset bacterial sepsis, known or suspected to be caused by Gram-positive microorganisms. 300 participants will be enrolled from five EU countries (Estonia, Greece, Italy, Spain and the United Kingdom). St Mary’s Hospital was the first UK site to recruit to this study.
  • Spring – is a two year UK study which aims to understand the inter-relationship between genetic risks, preterm birth and neurodevelopmental outcomes in babies born <32 weeks gestation and their parents.
  • Vitamin K – is an exploratory study with the prime aim of obtaining some preliminary data about vitamin K and folic acid status in preterm infants at neonatal discharge and in early infancy. In the absence of post-discharge supplementation with extra vitamin K/ folic acid, it is hypothesised that preterm infants (<33 weeks gestation) who are exclusively or predominantly human milk feeding at discharge will have a high prevalence of subclinical deficiencies of vitamin K and folic acid in early infancy (at approximately three months corrected age).
  • Baby-Oscar – Outcome after Selective Early Treatment for Closure of Patent Ductus ARteriosus in Preterm Babies born at 23+0 to 28+6 weeks of gestation and less than 72 hours old. The trial involves 30 sites in the UK.
  • MOCD – A Phase 2/3, Multicenter, Multinational, Open-Label Study to Evaluate the Efficacy and Safety of ALXN1101 in Neonates with Molybdenum Cofactor Deficiency (MoCD) Type A. As a rare genetic disorder there are 14 countries and 34 sites aiming to recruit a minimum of five patients and maximum of 10 patients.
  • INVOS – is a pilot study to introduce and validate non-invasive cerebral saturation monitoring during transfer and transportation of the neonate with the aim to provide clinicians with more in depth information about the patient’s oxygenation throughout transfer. The aim is to recruit up to 20 participants who require non-emergency transfer. Cerebral saturation monitoring during neonatal transfer is hypothesised to provide key additional parameter for clinicians to assess the patient’s full clinical condition utilising a practical, non-invasive technique suitable for effective use within an ambulance.
  • Biphasic CPAP – to compare CO2 levels in capillary gas of babies on N-CPAP or Biphasic CPAP within the first 48 hours following extubation with the hypothesis that in preterm infants born before 30 weeks gestation and less than two weeks old, minute ventilation is better with Biphasic CPAP than N-CPAP at equivalent mean airway pressure following primary extubation.

For more information about these studies and other research at the Neonatal Intensive Care Unit please contact Clinical Research Nurse / Research Coordinator / or 0161 276 3863.