Comparison of Two Nasal Interface for CPAP in Preterm
Condition: Respiratory Distress Syndrome in Premature Infant
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Observational

Summary: 
      Continuous distending airway pressure (CPAP) has gained popularity as a means to provide
      non-invasive respiratory support in neonates to reduce ventilator induced lung injury (VILI).
      However, maintaining CPAP in preterm infants has been challenging, often related to issues
      with nasal interface such as nasal septal injury, problems with keeping the prongs in the
      nose and leak around the prongs with are important factors in proving effective CPAP. RAM
      cannula was recently approved for providing supplemental oxygen and soon adapted by many
      centers to provide CPAP in preterm infants. Concerns have been raised that RAM cannula
      interface results in sub-optimal pressure delivery compared to standard nasal prongs.
    

Detailed description: 
      Objective:

      To compare efficacy of delivering continuous distending pressure in preterm neonates using
      RAM cannula versus the standard prongs (Hudson prongs) by measuring intra-oral pressure. It
      is hypothesize that CPAP delivered with RAM cannula is comparable to pressure delivered via
      standard nasal interface in routine clinical practice; and the desired CPAP level is often
      not achieved in presence of variable leak from mouth irrespective of type of nasal interface.

      Aim 1: Compare the level of CPAP in oral cavity between RAM cannula and Hudson prong nasal
      interface in preterm Hypothesis: The intraoral pressure with CPAP will not be different with
      use of RAM cannula or Hudson prong nasal interface

      Aim 2: Evaluate the effect of nasal interface (RAM cannula and Hudson prong) on respiratory
      variables Hypothesis: There will be no difference in respiratory variables with CPAP
      delivered by RAM cannula compared to Hudson prongs.

      Method:

      This was a single center prospective study. Inclusion criteria: Any preterm with respiratory
      distress requiring CPAP but not mechanical ventilation or NIPPV was eligible for the study.
      12 preterm infant more than 48 hours old and stable on bubble CPAP were recruited for the
      study Exclusion criteria: Infants with major congenital anomalies, neuromuscular disorders,
      upper airway anomalies, critically sick infants

      CPHS approval and parental consent was obtained prior to enrollment in the study.

      Each infant was studied for ~1 hour during which the oral pressure was measured while
      receiving CPAP with RAM nasal cannula interface and then with Hudson prongs. Blinding of the
      intervention (nasal interface) was not feasible because of the visible differences in the two
      nasal interfaces.

      Procedure: Intra-oral pressure measured via a differential pressure transducer while infant
      in receiving CPAP, and digitized data recorded with each nasal interface ( goal to record at
      least 20 sec of stable waveform on each nasal interface). Standard care provided during the
      study period and no changes made with CPAP level or flow.

      The difference between set pressure and measured pressure with RAM cannula and Hudson prong
      was compared with standard paired student t-test with 95% confidence limits. Difference in
      other variables will be similarly compared with t-test. STAT 12 will be used for statistical
      analysis.
    

Intervention name(s): RAM cannula and Hudson prongs
Intervention type(s): Device
Intervention description(s): Measuring intraoral pressure using two different nasal interface for applying nasal continuous positive airway pressure
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Any preterm with respiratory distress requiring CPAP
      
Keywords: Continuous positive airway pressure, preterm