Infants with CDH:Determining the Appropriate Level of Volume Guarantee

  • Research type

    Research Study

  • Full title

    Optimisation of neonatal ventilation in infants with Congenital Diaphragmatic Hernia (CDH)- determining the appropriate level of volume guarantee

  • IRAS ID

    201801

  • Contact name

    Anne Greenough

  • Contact email

    anne.greenough@kcl.ac.uk

  • Sponsor organisation

    Kings College London

  • Clinicaltrials.gov Identifier

    NCT02849054

  • Duration of Study in the UK

    1 years, 11 months, 30 days

  • Research summary

    New forms of breathing support for newborn babies have been developed with the aim of minimising lung damage. One of these new forms, called volume targeted ventilation (VTV), delivers the same size of inflation (mechanical breath) to the baby despite changes in their lung function. We have shown in studies approved previously, that in both prematurely and term born infants with acute breathing problems, larger rather than smaller mechanical breaths appear to reduce the breathing effort required from the baby. It is not known, however, what size of inflation is best for infants born with Congenital Diaphragmatic Hernia (CDH) who may have poorly grown (hypoplastic) lungs and remain ventilator dependent for many weeks if not months. Term born infants with other pathologies have very different lung function to CDH infants, thus the results from other term born infants cannot be extrapolated to CDH infants. It is therefore essential, and the aim of this study, to determine what is the optimum level of volume targeting for CDH infants.

    We will assess how hard they are working to breathe while we give different breath volumes (sizes) via the ventilator (within the normal baby breathing range). The best mechanical breath size will be determined by the level at which the baby has the lowest work of breathing. The baby will subsequently receive that size of mechanical breath while they remain on breathing support.

  • REC name

    London - Camden & Kings Cross Research Ethics Committee

  • REC reference

    16/LO/0887

  • Date of REC Opinion

    27 May 2016

  • REC opinion

    Favourable Opinion