Newborn Respiratory Distress Syndrome Clinical Trial
Official title:
HHHFNC (Heated Humidified High-Flow Nasal Cannula) Versus NCPAP (Nasal Continuous Positive Airway Pressure) in Preterm Infants With Mild to Moderate Respiratory Distress Syndrome (RDS): a Randomized Clinical Trial.
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).
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment