NIV-MISA-NRDS Trial: a Multicenter Study in China
- Conditions
- Minimal Invasive Surfactant Administration in Two Different Non-invasive Ventilation Modes to NRDS Infants
- Interventions
- Other: Nasal continuous positive airway pressure and Non-invasive positive pressure ventilation
- Registration Number
- NCT05137340
- Lead Sponsor
- Peking University Third Hospital
- Brief Summary
BACKGROUND Non-invasive ventilation (NIV) treatment have been developed to minimize lung damage and to avoid invasive mechanical ventilation (IMV) in preterm infants, especially in those with gestational age less than 30 weeks. Our hypothesis is that for preterm infants less than 30 weeks with potential to develop neonatal respiratory distress syndrome (NRDS), nasal continuous positive airway pressure (NCPAP) is non-inferior to the nasal intermittent positive pressure ventilation (NIPPV) as primary respiratory support before minimal invasive surfactant administration (MISA).
DESIGN, SETTING, AND PARTICIPANTS The NIV-MISA-NRDS trial is planned as an unblinded, multicenter, randomized, non-inferiority trial at 14 tertiary care neonatal intensive care units in China. Eligible infants are preterm infants of 24 to 29+6 weeks' gestational age who have spontaneous breaths at birth and require primary NIV support for NRDS in the first 2 h of life. Infants are randomized 1:1 to treatment with either NCPAP or NIPPV once admitted into neonatal intensive care unit (NICU). If the patient with progressively aggravates respiratory distress and clinically diagnose as NRDS, pulmonary surfactant will be supplemented by minimal invasive surfactant administration (MISA) in the first 2 hours .
MAIN OUTCOMES AND MEASURES The primary outcome is NIV treatment failure within 72 hours after birth, as determined by objective oxygenation, blood gas, and apnea criteria, or the need for intubation and mechanical ventilation. Secondary outcomes mainly include the incidence of complications during hospitalization . With a specified noninferiority margin of 10%, using a two-sided 95% CI and 80% power, the study requires 480 infants per group (total 960 infants in the study).
- Detailed Description
The ventilator parameter of NCPAP group are set with positive end expiratory pressure \[PEEP\] of 6cmH2O (adjustment range 6-8cmH2O) and FiO2 of 0.21-0.40, in order to maintain an oxygen saturation level of 90%-95%.
NIPPV group are set with PEEP of 6cmH2O (adjustment range 6-8cmH2O), peak inspiratory pressure \[PIP\] of 15cmH2O (regulation range 15-20cmH2O), inspiratory time of 0.3s (regulation range 0.3-0.4s), respiratory rate of 30 times/min (regulation range 20-40 times/min) and FiO2 of 0.21-0.40.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 312
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NCPAP group Nasal continuous positive airway pressure and Non-invasive positive pressure ventilation Participants enrolled spontaneously breathing preterm infants born between 24 and 29.9 weeks' gestational age with signs of respiratory distress syndrome. The initial respiratory support mode of premature infants assigned to NCPAP group was NCPAP. Patients diagnosed with NRDS on NCPAP were given a therapeutic dose of pulmonary surfactant via MISA within 120 minutes after birth. NCPAP group ventilator parameter setting: PEEP 6cmH2O (adjustment range 6-8cmH2O), FiO2 adjustment range 0.21-0.40, in order to achieve postnatal target oxygen saturation. NIPPV group Nasal continuous positive airway pressure and Non-invasive positive pressure ventilation Participants enrolled spontaneously breathing preterm infants born between 24 and 29.9 weeks' gestational age with signs of respiratory distress syndrome. The initial respiratory support mode of premature infants assigned to NIPPV group was NIPPV. Patients diagnosed with NRDS on NIPPV were given a therapeutic dose of pulmonary surfactant via MISA within 120 minutes after birth. The initial ventilator parameters of NIPPV group were as follows: PEEP 6cmH2O (adjustment range 6-8cmH2O), PIP15cmH2O (regulation range 15-20cmH2O), inspiratory time 0.3s (regulation range 0.3-0.4s), respiratory rate 30 beats/min (regulation range 20-40 beats/min), and FiO2 regulation range 0.21-0.40 in order to achieve postnatal target oxygen saturation.
- Primary Outcome Measures
Name Time Method NIV treatment failure within the first 72 hours of life From enrollment to the first 72 hours of life The failure of non-invasive nasal respiratory support(NIPPV or NCPAP) within the first 72 hours of life
- Secondary Outcome Measures
Name Time Method Rate of intraventricular hemorrhages (IVH, grade III or Ⅳ) Through study completion and up to corrected three months Rate of intraventricular hemorrhages (IVH, grade III or Ⅳ)
Rate of periventricular leukomalacia Through study completion and up to corrected three months Rate of periventricular leukomalacia
Rate of late-onset sepsis Through study completion and up to corrected three months Rate of late-onset sepsis
Rate of bronchopulmonary dysplasia (BPD) At 36 weeks PMA Rate of bronchopulmonary dysplasia (BPD)
Rate of necrotizing enterocolitis (NEC) Through study completion and up to corrected three months Rate of necrotizing enterocolitis (NEC)
Rate of retinopathy of prematurity (ROP) Through study completion and up to corrected three months Rate of retinopathy of prematurity (ROP)
Required>1 doses of surfactant From enrollment to 5 days after birth rate of required\>1 doses of surfactant
In-hospital mortality Through study completion and up to corrected three months In-hospital mortality
Pneumonia Through study completion and up to corrected three months rate of pneumonia
Persistent pulmonary hypertension of newborn Through study completion and up to corrected three months rate of persistent pulmonary hypertension of newborn
Rate of pulmonary hemorrhage Through study completion and up to corrected three months Rate of pulmonary hemorrhage
Rate of hemodynamically significant patent ductus arteriosus (hsPDA) Through study completion and up to corrected three months Rate of hemodynamically significant patent ductus arteriosus (hsPDA)
Length of hospital stay From enrollment to the end of treatment at an average of 8 weeks Length of hospital stay
NIV treatment failure within 7days after birth From enrollment to 7days after birth The failure of non-invasive nasal respiratory support(NIPPV or NCPAP) within 7days after birth
Rate of pneumothorax Through study completion and up to corrected three months Rate of pneumothorax
Duration of non-invasive ventilation, IMV, and supplemental oxygen Through study completion and up to corrected three months Duration of non-invasive ventilation, duration of IMV, and days on supplemental oxygen
Trial Locations
- Locations (1)
Peking University Third Hospital
🇨🇳Beijing, China