TSuNaMI-II

• Research type

  Research Study

• Full title

  Treatment of neonatal chronic lung disease (nCLD). The Surfactant, Nutrition and Microorganism Interactions study in infants at risk of developing chronic lung disease - 2 (TSuNaMI-II)

• IRAS ID

  77889

• Contact name

  Kevin Goss

• Sponsor organisation

  University Hospital Southampton NHS Foundation Trust

• Eudract number

  2011-000811-23

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The survival of infants born prematurely between 23 and 29 weeks gestation has improved dramatically since the introduction of replacement surfactant therapy. However up to 40% of survivors will develop neonatal Chronic Lung Disease (nCLD) a condition with considerable associated morbidity. Surfactant is a naturally produced detergent in the mature lung and amongst other functions helps prevent lung collapse. There is no single factor associated with the development of nCLD with infection, inflammation, oxygen toxicity, nutritionally mediated metabolic disturbances and ventilator-induced lung injury all implicated as causal agents. We hypothesise that these mechanisms produce an insult to surfactant biology causing injury to the preterm infant??s lung surfactant system. The resulting alveolar instability with prolonged ventilator dependence and an increased exposure to pathogenic micro-organisms will, in susceptible infants, increase the severity of the nCLD. If the surfactant biology can be characterised in these infants, it may provide avenues for therapeutic intervention. We aim to identify and recruit premature infants at high risk of developing nCLD (born between 23 and 29 weeks gestation), born in the large neonatal units within the hospitals of Southampton and Portsmouth. Secretions produced in the ventilator tube of premature infants that have been attached to assist in their breathing will be collected for analysis. By first giving the premature infant a safe, labelled essential nutrient (methyl-D9 choline chloride) in the first 24 hours of life, we will be able to accurately characterise surfactant biology and lung mechanism. Following this, if, on the 5th day of life, the infant is still intubated and requiring assistance from a mechanical ventilator, an additional (to standard care) dose of surfactant will be given.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  12/SC/0264

• Date of REC Opinion

  22 Jun 2012

• REC opinion

  Further Information Favourable Opinion