Clinical Trial: Flow-cycled Ventilation in Preterm Infants

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Flow-cycled Ventilation in Preterm Infants (FLIPI): A Pilot Study Looking at the Tolerance of Flow-cycled Ventilation by Preterm Infants With Respiratory Distress Syndrome

Brief Summary:

This short pilot study is to assess the tolerance of preterm infants, born below 32 weeks gestation with respiratory distress syndrome, to flow-cycle ventilation, and see if infants require less overall pressure from the ventilator than the usual conventional settings used, with the aim of providing data to construct a larger trial looking at the longer term outcome of these infants using this type of ventilation in the future.

Many preterm infants at these gestations require assistance from a ventilator due to the immaturity of their lungs. The lungs of preterm infants are susceptible to damage, especially if high pressures are needed or prolonged periods of ventilation. There is concern that if the infant's breathing pattern does not synchronise with the ventilator, this causes additional distress, longer duration of ventilation needed and increased risk of complications. Over the past 20 years, a different type of ventilation, known as flow-cycle ventilation, has been trialed, with limited use in preterm infants. This allows the baby to determine the duration of breathing in and out and how many breaths they require per minute. This would help babies to synchronise better with the ventilator, and consequently require less pressure from the ventilator.

This pilot study is being conducted at St. Mary's Hospital, Manchester. All babies born under 32 weeks gestation, with a stable respiratory effort, will be eligible for consideration for the study. The study will last no longer than 5 hours and involve the babies receiving different pressures from the ventilator in flow-cycle mode for 1-hour epochs. Blood gases after each epoch and continuous ventilator data will be downloaded to assess their tolerance on the different settings, before being returned to the usual conventional settings used on the unit. The babies will have

Detailed Summary:

This study will be conducted as a short term, crossover study, where each infant will act as his or her own control and undertake all interventions within this study. The study is broken down into two parts in order to answer the two secondary research questions.

The limited studies looking at flow-cycled ventilation in preterm babies have been set up in a similar manner. Making each infant its own control limits the number of infants needed for this pilot study.

  1. Prior preparations regarding protocol design

    The protocol has already been reviewed by the University of Leeds, by paper submission and viva to determine the suitability of the project from an educational point of view and suitability for the restricted time frame and resources available. Discussions with the neonatal unit technical support staff have already been undertaken to ensure that the study ventilators (an exact model to that used on the unit, but mobile) are configured with the required backup ventilation mode, to maintain the required level of breathing support, safety alarms and settings checked and the Eview box (device which allows the collection of data about the baby from the ventilator) installed as per manufacture guidelines.

    Training has also been given to the Principal investigator on the setup and maintenance of the study ventilator (the principal investigator is also a member of the clinical team who uses these ventilators on a daily basis and aware of how they are used).

  2. Prior clinical care given & assessment for eligibility

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    Sponsor: Central Manchester University Hospitals NHS Foundation Trust

    Current Primary Outcome:

    • Mean airway pressure used [ Time Frame: 6 hours ]
      Amount of pressure required in either ventilation mode
    • Inspiratory time [ Time Frame: 6 hours ]
      Amount of time the infant require inspiratory support from the ventilator (in flow-cycle mode only)
    • Respiratory rate [ Time Frame: 6 hours ]
      Spontaneous respiratory rate from infant in either ventilation mode


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Exhaled tidal volume [ Time Frame: 6 hours ]
      Amount of gas exhaled (measured in mls, ml/kg body weight)
    • Exhaled minute ventilation [ Time Frame: 6 hours ]
      Product of exhaled tidal volume and respiratory rate
    • Oxygen requirement [ Time Frame: 6 hours ]
    • Acid - base balance [ Time Frame: In each 1-hour epoch (end of) ]
      Assessment of pH and carbon dioxide clearance in each ventilation mode


    Original Secondary Outcome: Same as current

    Information By: Central Manchester University Hospitals NHS Foundation Trust

    Dates:
    Date Received: August 9, 2015
    Date Started: September 2015
    Date Completion:
    Last Updated: February 11, 2017
    Last Verified: February 2017