Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT02396693
Brief 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).
Study:
NCT02396693
Study Brief:
Protocol Section:
NCT02396693