HHHFNC (Heated Humidified High-Flow Nasal Cannula) Versus NCPAP for Respiratory Distress Syndrome of Prematurity
Condition: Newborn Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Hyaline Membrane Disease; Syndrome
Study type: Interventional

Summary: 
      Preterm infants ranging from 29+0 to 36+6 weeks+days are randomly assigned to one of the
      following treatments as non invasive respiratory support if they develop mild to moderate
      Respiratory Distress Syndrome within 72 hrs from birth: 1) NCPAP set at 4-6 cmH2O or 2)
      HHHFNC providing a flow 4-6 l/min.

      The aim of the study is to assess efficacy and safety of relative "new" form of respiratory
      support (HHHFNC) versus a more common one (NCPAP).
    

Detailed description: 
      Preterm infants are eligible to the study if they present mild to moderate Respiratory
      Distress Syndrome (RDS) defined by the following criteria: need of FiO2 ( Fraction of
      Inspired Oxygen) ≥0.30 to keep a target SpO2 (Periferal Oxygen Saturation) beetween 88-93%
      and/or Silverman score ≥5. To confirm the diagnosis a Chest XR is performed as routinarily in
      the ward before starting the respiratory support.

      They are randomly assigned to one of the treatment groups cited in "brief summary" by means
      of closed envelops. A block randomization is applided with a blok size of 4. The
      randomization is stratified per groups accoring to gestational age: from 29+0 to 32+6; from
      33+0 to 34+6; from 35+0 to 36+6 weeks+days.

      Once the treatment is started, for the group NCPAP there is the possibility to switch to the
      mode "Bi-PAP" if: there are more than 4 episodes of apnoea per hour or more than 2 episodes
      requiring positive pressure ventilation or if deemed by clinicians for increased work of
      breathing assesed by the Silverman score.

      For all the groups, if the FiO2 requirement is persistently higher than 0.35-0.40 per target
      SpO2 86-93% and/or dyspnoea defined by Silverman score > 6 after starting the respiratory
      support, newborns receive Surfactant by "INSURE" technique, involving endotracheal intubation
      by direct laryngoscopic vision, endotracheal administration of surfactant (Curosurf, Chiesi
      Pharmaceutics, Parma, Italy) 200 mg/kg and finally extubation.

      After the administration of surfactant, if FiO2 requirement is persistently >0.4 to keep SpO2
      86-93% or severe apnea episodes are present (apnea episodes > 4/hr or >2/hr requiring
      positive pressure ventilation) or at the blood gas (capillary or venous) PaCO2>70 mmHg and
      pH<7.20, newborns are intubated and mechanically ventilated.

      For all the newborns enrolled in the study, capillary or venous blood gas is checked every
      6-12 hours, a cerebral and cardiac ultrasound screening is performed within 24 hrs. Further
      controls follow the routine of the ward.

      Weaning is started decreasing HHHFNC flow by 1 lpm or nCPAP pressure by 1 cmH2O pressure if
      infants are presenting FIO2 < 0.30 to target SpO2 and minimal or no signs of respiratory
      effort. The respiratory support is discontinued for flow ≤ 2 lpm or pressure ≤ 2 cmH2O.
    

Intervention name(s): HHHFNC; NCPAP
Intervention type(s): Device; Device
Intervention description(s): infants receive non-invasive respiratory support by mean of HHHFNC; infants receive non-invasive respiratory support by mean of NCPAP
Other intervention name(s): PRECISION FLOW (Vapotherm,Stevensville, USA); Infant Flow Driver System (EME Ltd, Brighton, Sussex, UK); SiPAP (Viasys Healthcare, Palm Springs, CA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NCPAP, High Flow Nasal Cannula, pretem infants, NICU