Effects of Nasal High Flow Therapy on Ventilation and Gas Exchange in Healthy Newborns
Condition: Respiratory Support
Study type: Interventional

Summary: 
      Nasal High Flow (NHF) and CPAP are established forms of respiratory support in neonates and
      often produce similar clinical outcomes. It has been shown in adults that NHF produce
      different effects on ventilation during wakefulness and sleep. There is no physiological data
      on effects of NHF in neonates. The physiological effects may be impacted by sleep/awake
      status.
    

Detailed description: 
      The aim of the study to investigate the effects of NHF therapy on ventilation and gas
      exchange during wakefulness and sleep in healthy term newborns.

      Interventions:

      NHF will be applied at 8 L/min (AIRVO 2) via (OPT 316) Optiflow nasal cannula interface
      without supplemental oxygen. Participants will act as their own control (no intervention) in
      a randomized crossover study design.

      Physiological measurements:

        1. Ventilation will be assessed using Respiratory Inductance Plethysmography (RIP)
           (Respitrace QDC, Viasys, USA).

        2. Blood carbon dioxide (CO2) and oxygen levels will be measured by a non-invasive
           transcutaneous monitor (Tosca, Radiometer, Demnark).

        3. All experiment will be recorded using Analogue-to-Digital converter (Powerlab,
           ADInstruments, New Zealand) and LabChart software with video recording of the patient.

        4. Sleep/awake statuss will be determined by videorecording of the patient and
           Electroencephalogram (EEG) (Alice Polysomnography System Philips, USA)

        5. The total study time will be <3 hours in total for each participant. Routine measurement
           of heart rate, respiratory rate and oxygen saturation will be performed as per standard
           neonatal clinical practice.

        6. Intervention can be terminated if at any time SpO2 drops below 80%, TcCO2 increases
           above 60 mm Hg, Respiratory Rate increases above 80 breaths per min for more than one
           minute).

      The researcher is an experienced neonatal consultant will be conducting the research and
      observing the baby throughout the study.

      Protocol:

      Both control and NHF intervention periods will last a maximum of 40 min each. The maximum
      duration of the study including set-up, calibration, intervention, washout ans control will
      be <3 hours. At the beginning of the study when all probes are attached a self-calibration
      period of RIP will be followed by a calibration of breathing volume with a pneumotachometer
      attached to a nasal mask. After all calibrations are completed a baseline measurement will be
      followed by either NHF 8 L/min or a control period without NHF. At the end of this period the
      interventions will be changes either to control or NHF, which will follow by a washout period
      (no NHF) and an additional calibration of RIP with a pneumotachometer.
    

Intervention name(s): Nasal High Flow
Intervention type(s): Device
Intervention description(s): Nasal High Flow Therapy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nasal High Flow; gas exchange; newborn