Comparison of Continuous Positive Airway Pressure and Non Invasive Positive Pressure Ventilation
Condition: Respiratory Distress of Newborn
MeSH terms: Hyaline Membrane Disease; Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome
Study type: Interventional

Summary: 
      The objective of the study is to compare the effectiveness of treatment with Non Invasive
      Positive Pressure Ventilation (NIPPV) and continuous positive airway pressure (CPAP) in
      decreasing the requirement for endotracheal ventilation in neonates with respiratory distress
      within the first hours of birth.Primary outcome is the non invasive respiratory support
      failure and the need for intubated ventilatory support during the first 72 hours of life.

      Randomized control , single center trial. Eighty neonates admitted to Neonatal Intensive Care
      Unit (NICU) were randomly allocated to NIPPV and CPAP. Outcomes of respiratory support were
      observed and information on risk factors were obtained by going through bed head ticket.
    

Detailed description: 
      Objective of the study:

      To compare the effectiveness of CPAP and NIPPV in neonates with mild to moderate respiratory
      distress.

      Specific objectives To determine the effectiveness of CPAP and NIPPV in neonates with mild to
      moderate respiratory distress To describe neonatal factors associated with CPAP and NIPPV
      support. To compare the length of hospital stay in neonates who received CPAP and NIPPV To
      compare the time taken to achieve full enteral nutrition in neonates who received CPAP and
      NIPPV.

      Study design:

      Randomized controlled trial

      Study setting:

      Study carried out in NICU of the Sri Jayawardanapura General Hospital There are 06
      ventilators in NICU of Sri Jayawardanapura Hospital. (Three SLE 2000 infant ventilators and
      three Bear CUB 750 psv infant ventilators.) Respiratory support (conventional ventilation,
      CPAP and NIPPV) gave through these ventilators. The neonatal soft tip curved nasal canula
      with tubing will be use for non invasive respiratory support. The nasal canula connected to
      the ventilator via an endotracheal tube connector. Systems were regularly monitored. Canula
      size was chosen to comfortably fit the infant's nostrils.

      CPAP started with Positive end expiratory pressure (PEEP) 05 and increased up to PEEP 09
      according to the severity of baby's condition.

      NIPPV started with intermittent Mandatory ventilation (IMV) rate 30, peak inspiratory
      pressure (PIP) 20 and PEEP 5.Increased the settings according to the severity of baby's
      condition.

      Sampling Method. All neonates fulfilling inclusion and exclusion criteria registered in the
      study. And a serial number issued. They were allocated to the two arms of study randomly
      based on a previously generated random allocation schedule.

      They were managed according to hospital management protocol and outcome data were collected
      from the bed head ticket.

      The ethical approval taken from the Ethical Review Committee of Sri Jayawardenepura General
      Hospital kotte.

      Approval taken from Medical Technology and supplies sub committee on clinical trials Written
      informed consent obtained from parents or guardians of eligible infants before randomization
      The data sheets did not contain the name and be anonymous. Data stored under lock and key
      with restricted access only to the principal investigators. The computerized data were
      password protected and is only available to the investigators.
    

Intervention name(s): CPAP; NIPPV
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The neonates with mild to moderate respiratory distress were randomly allocated to tratment with NIPPV and CPAP.
Masking: None (Open Label)
Primary purpose: Treatment