Using Nasal High Flow From Birth in Premature Infants - a Pilot Study
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Recent large studies have shown that not all premature babies need to be intubated (have a
      breathing tube inserted) and ventilated, nor do they all need to be given lung surfactant
      routinely. Those studies showed that even very small babies can be safely supported using
      nasal Continuous Positive Airway Pressure (nCPAP) which is applied tightly to the nose using
      nasal prongs. This is a type of noninvasive ventilation (NIV) so that the babies continue to
      breath, albeit with additional support to reduce their work of breathing. However nCPAP has
      some drawbacks, including that it can cause skin damage to the nose, and that the heating and
      humidification of the gas is not always sufficient. We have been using, for over 5 years, a
      different system to support babies after routine intubation. This is another type of
      noninvasive ventilation called nasal High Flow (nHF) for which we use a Vapotherm Precision
      Flow device. Published trials show that it is at least as effective as nCPAP to provide NIV
      and to prevent the subsequent need for intubation and/or surfactant. However nHF is superior
      to nCPAP in respect it does not cause nose damage and its heating and humidification is
      excellent. This pilot study aims to describe and evaluate the use of nHF, using a standard
      commercially available system (Precision Flow, Vapotherm Inc.), from birth, in babies born
      less than 30 completed weeks gestation, with a view to avoiding intubation and ventilation.
      This study is important to establish the feasibility of using nHF immediately after birth.
    

Detailed description: 
      We propose to pilot the use of this mobile nHF unit, using the Vapotherm Precision Flow
      device, in the premature population of babies who would normally be either intubated and
      given surfactant routinely, or be maintained on nCPAP until arrival on the Neonatal Intensive
      Care Unit (NICU) then transferred onto nHF. Parents will be informed about the pilot and
      their permission will be sought. We aim to recruit 40 babies less than 30 weeks gestation.

      The reason for undertaking a pilot study of this nature is to establish feasibility and proof
      of concept. It is not designed to be compared to using nCPAP to stabilise babies immediately
      after birth (although that will be the next and logical progression if this proves to be a
      feasible technique).

      The hypothesis is that using nHF to stabilise babies immediately after birth will confer the
      same advantages as using nCPAP to stabilise babies in this way, which has been demonstrated
      in the worldwide literature. For units such as ours who use nHF in preference to nCPAP, this
      will be an important step in further defining the management of these babies after birth.
      There is evidence that nHF is at least as good as nCPAP in preventing intubation and reducing
      lung disease, and it may also offer additional advantages from humidification and reduction
      in nasal trauma.

      The major challenge for this pilot project will be to identify eligible deliveries in a
      timely manner to ensure that a suitable member of staff is available to speak to parents and
      gain consent.

      Once a delivery has been identified and the parents have agreed to take part, then the
      following process will take place to manage the newborn baby.

      Check the mobile nHF unit

        -  The mobile nHF unit should be kept plugged in so that the uninterruptable power supply
           (UPS) is fully charged

        -  To use it, unplug it to check that the UPS is functioning (green lights indicate full
           charge), set up a Vapotherm circuit(as per normal routine) and start the machine running
           on UPS power supply.

        -  Gas supply should be from the cylinders to check that the pressures are 50bar in both
           air and oxygen cylinders

        -  Set the temperature to 37 degrees Celsius

        -  Once running, turn the unit off if not immediately needed or plug into the mains power
           and gas(es) where available to conserve gas. The unit can be run on a flow of 1
           litre/minute whilst "ticking over" to conserve cylinder gas if needed.

        -  The prongs should be attached to the circuit.

      Once the baby is born

        -  Place the baby in a polythene bag (as per normal practice)

        -  Ensure the baby is breathing. If not, or the baby is bradycardic, then normal
           resuscitation measures should be applied. It will only be appropriate to apply the
           mobile nHF if the baby is breathing and is clinically stable.

        -  Once the baby is born, increase the flow to 6 litres/min

        -  If the baby is breathing then apply the nHF prongs and observe carefully

        -  Suction should only be applied gently, if needed to remove excessive secretions in the
           mouth and throat. Babies on high flow will often "blow bubbles" and there may be lung
           fluid in the throat, but suction should not be vigorous

        -  Apply a saturation monitor (as per normal practice) to check Heart Rate (HR) and Oxygen
           Saturation (SaO2).

        -  Dry the baby's face sufficiently to be able to apply duoderm dressing to stick down the
           prongs to the cheeks.

        -  Observe the baby carefully, ensure attention to thermal care and inform the parents
           about progress.

        -  As soon as the baby appears stable, move to NICU as per normal practice

      Transfer to NICU

        -  Two people are needed to effect the transfer from labour ward/theatre to NICU, one to
           move the mobile nHF and one to move the resuscitaire.

        -  On arrival in NICU, plug the mobile nHF into gas and power supplies (switch the manifold
           over)

        -  Ensure that there is a second, cotside Vapotherm (empty) unit

        -  Leave the baby in the resuscitaire and check the admission temperature.

        -  Stop the mobile nHF, remove the cartridge and place it into the cotside Vapotherm unit.
           Start it running, it should run straight away. Ensure that the correct temperature, flow
           and Fraction Of Inspired Oxygen (FiO2) are set

        -  This process takes less than 20 seconds and as the baby is breathing will not be
           detrimental

        -  Transfer the baby into the incubator and commence normal admission practices

        -  Document the resuscitation clearly in the baby's notes

      Cleaning and charging the mobile nHF

      o Remove the mobile nHF, clean the Vapotherm Precision flow nHF unit. Ensure the cylinders
      are switched off and plug into the wall to recharge the UPS.
    

Intervention name(s): Vapotherm Precision Flow
Intervention type(s): Device
Intervention description(s): Application of nasal High Flow using 6-7 l/min delivered by nasal prongs from birth
Other intervention name(s): nasal High Flow device; nasal heated humidified high flow cannula
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: nasal High Flow; premature baby; CPAP (Continuous positive airways pressure)