Successful Extubation and Noninvasive Ventilation in Preterm ≤ 1500g Terms
Condition: Respiratory Distress Syndrome In Premature Infants
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Interventional

Summary: 
      Noninvasive ventilation has been used in preterm newborn with respiratory distress syndrome
      in an attempt to assist failure extubation. The investigators investigated failure extubation
      in infants gestational age less than or equal to 34 weeks and weights less than or equal to
      1500 grams. Neonates were randomized to noninvasive modalities support. 101 newborns were
      included in this study in three groups , group 1: Nasal Intermittent Positive Pressure
      Ventilation (NIPPV) (n=36), group 2: Nasal Continuous Positive Airway Pressure Bubble (NCPAP
      bubble) (n=33) and group 3: Nasal Continuous Positive Airway Pressure Bubble Ventilator
      (NCPAP ventilator) (n=32)
    

Detailed description: 
      The infants were randomly allocated after extubation used a list of computer-generated
      randomization in NIPPV modes (with the following settings: positive inspiratory pressure
      (PIP) < 16 centimeters of water (cm H2O), positive end-expiratory pressure (PEEP) 4-5
      centimeters of water (cm H2O, backup respiratory rate (RR) < 18 cycles per minute flow 6-7
      liters per minute (L / min) and inspiratory time (TI) according to the time constant for idae
      (0.30 to 0.34 seconds), and respirator seal to NCPAP water tower was adjusted to 4-5
      centimeters of water (cm H2O) PEEP, flow 6-7 liters per minute (L / Min.) oxygen for both was
      adjusted to maintain arterial oxygen saturation between 85-95%

      The criteria for extubation were defined using a protocol by the clinic staff, confirmed by
      arterial blood gases and chest X-ray, as well as adjustments of the ventilator settings.

      Vital signs, blood gas parameters and noninvasive brackets were recorded before, immediately,
      15, 30, 45 minutes, 1(hour) h, 2h, 12h, 24h and 48 h after extubation were documented.

      Neonatal morbidities were documented until discharge, among these are: patent ductus
      arterious, necrotizing enterocolitis, retinopathy of prematurity, intracranial hemorrhage and
      pneumothorax.

      Data on achievement of prenatal, antenatal steroids and surfactant administration were
      documented. All newborns were natural porcine surfactant Curosurf®.

      The total duration of mechanical ventilation and oxygen were documented from birth until
      discharge or death. The supplemental oxygen or mechanical ventilation days was defined as
      daily requirement of fraction of inspired oxygen (FiO 2)> 0.21 or ventilation > 12 hours,
      respectively.

      The newborns were followed for all interaction until discharge (about 5 weeks).
    

Intervention name(s): NIPPV; Bubble NCPAP; Ventilator NCPAP
Intervention type(s): Device; Device; Device
Intervention description(s): Ventilation with nasal intermittent positive pressure - Newborns randomized to this group underwent NIPPV, the respirators in TIME mode, set with the following settings : 5-6 centimeters of water (cmH2O) pressure positive end expiratory (PEEP); Flow rate of 6-8 liters per minute (L / min); PIP(positive inspiratory pressure) < 15 centimeters of water (cm H2O) ; respiratory frequency backup (FR) < 16 bpm; inspiratory time (IT) - 0.30 to 0.33 seconds (adjustable time constant according to the weight and baseline disease); Bubble NCPAP - Newborns randomized to this group bubble NCPAP, adjusted with the following settings: pressure positive end expiratory (PEEP) 5-6 centimeters of water (cm H2O) and Flow 6-8 liters per minute (L / min), provided through oxygen sources and compressed air (15 liters per minute - L / min), which passes through a heated humidifier through a breathing circuit that goes to the newborn, and from him, for a plastic container (250 milliliters (ml) capacity and 14 centimeters) containing sterile distilled water, which is the bubble.; Ventilator NCPAP - Newborns randomized to this group ventilator NCPAP, of respirators in TIME mode set with the following settings: pressure positive end expiratory (PEEP) 5-6 centimeters of water (cm H2O) and Flow 6-8 liters per minute (L / min).
Other intervention name(s): Non invasive ventilation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Newborn; non invasive ventilation