Short-term effects of synchronized vs. non-synchronized NIPPV in preterm infants: study protocol for an unmasked randomized crossover trial

Table 1 Data recorded before and during the study period

Before enrolment	During the study period
ANAMNESTIC VARIABLES - GA at birth - Birth weight - Delivery type - APGAR at 1/5 min (and 10 min if available) - Presence of intrauterine growth restriction - Maternal administration of magnesium sulfate - Steroid prenatal prophylaxis (number of doses) - Intrapartum antibiotic prophylaxis (if indicated) - Presence of intraamniotic infection and administration of intrapartum antibiotic therapy CLINICAL VARIABLES - Surfactant administration (time and number of doses) - Type and duration of MV previously administered (if any) - Type and duration of NIV previously administered (if any) - Corrected GA at enrolling - Caffeine doses administered (if any)	CARDIORESPIRATORY VARIABLES - FiO₂ to maintain SatO₂TC 90-94% (as weighted mean) - NIV failure^a and endotracheal intubation - Number of the cardiorespiratory events^b OTHER POLYGRAPH VARIABLES (continuous monitoring) - HR - RR - SatO₂ TC - thoracic impedance - from ventilator: trigger, pressure, flow - pressure in ventilator circuit CLINICAL VARIABLES - Neonatal Pain Scale score LABORATORY VARIABLES - BGA values at the end of stabilization phase, phase A and phase B

GA gestational age, MV mechanical ventilation, NIV non-invasive ventilation, SatO₂ TC transcutaneous O₂ saturation, HR heart rate, RR respiratory rate
^aNIV failure criteria: FiO₂ > 40%, pH < 7.2, pCO₂ > 65 mmHg, ≥ 3 episodes of desaturations (SatO₂ TC < 80%) per hour, ≥ 3 episodes of apnea (> 20 s) and/or bradycardia (HR < 80 bpm) per hour, Silverman score > 6. Necrotizing enterocolitis, bowel perforation, and hemodynamic instability are indications of NIV failure
^bCardiorespiratory events are defined as episodes of apnea lasting more than 20 s or over 5 s if followed by desaturation or bradycardia and/or episodes of desaturation with blood oxygen saturation below 80% for 4 s or more and/or episodes of bradycardia with HR below 80 bpm.

ISSN: 1745-6215