Very Early Surfactant and NCPAP for Premature Infants With RDS
Condition: Respiratory Distress Syndrome; Pneumothorax/Pulmonary Intersticial Emphysema; Chronic Lung Disease
MeSH terms: Lung Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Pneumothorax; Emphysema
Study type: Interventional
Phase: Phase 3

Summary: 
      The present study will test the use of very early nasal continuous airway pressure(NCPAP)with
      and without surfactant in premature infants with clinical evidence or respiratory distress
      syndrome. We hypothesize that premature infants exposed to very early NCPAP and surfactant
      will require less mechanical ventilation compared to those premature infants exposed to NCPAP
      alone.
    

Detailed description: 
      Premature infants who are not intubated during the first 15 minutes of life and who develop
      clinical evidence of respiratory distress or need for oxygen requirement between 15 and 60
      minutes of life, will be placed on bubble NCPAP of 6 cm H2O. Randomization envelops will them
      be opened and patients will be assigned to continuation on NCPAP alone (Control Group) or to
      NCPAP plus very early surfactant therapy (Treatment Group). Patients assigned to the
      treatment group will be transiently intubated for surfactant administration, extubated, and
      placed back on NCPAP of 6 cm H2O. Both groups will then be followed over time to determine
      which infants meet treatment failure criteria defined as: Treatment failure was defined a
      priori by either failure of adequate oxygenation or ventilation as follows: "1" FiO2 greater
      than 0.75 for more than 30 minutes to maintain SpO2 within the pre-established target ranges,
      "2" persistent or recurrent desaturation below 80% that did not respond to suctioning of the
      airways and PPV, "3" PCO2>65 mmHg and pH<7.22 on an arterial or capillary blood gas analysis,
      in association with increased work of breathing. Infants in the Treatment Group who cannot be
      extubated after their initial dose of surfactant because of clinical instability will be
      analyzed as treatment failures. Premature infants that meet treatment failure criteria on
      either arm will be intubated and placed on mechanical ventilation and given surfactant rescue
      doses according to the criteria of the participating institutions. Premature infants with
      respiratory distress syndrome who do not meet treatment failure criteria in both groups will
      remain on NCPAP until their respiratory failure improves.
    

Intervention name(s): Very early surfactant and bubble NCPAP; bubble NCPAP
Intervention type(s): Other; Other
Intervention description(s): For patients randomized to early NCPAP plus surfactant, 4ml/kg of surfactant were administered through an endotracheal tube in two aliquots, 2 minutes apart followed by positive pressure ventilation administered for one minute with a Neopuff Infant Resuscitator pre-set to give a peak pressure of 20 cm H2O and 5 cm H2O of positive end expiratory pressure. Infant was then extubated and placed on NCPAP of 6 cmH2O; Premature infants randomized to bubble NCPAP alone will continue on NCPAP until they reach "yes or no" treatment failure criteria.
Intervention MeSH terms: Pulmonary Surfactants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NCPAP; Very early surfactant