An interventional study of Nasal continuous positive airway pressure and Non-invasive positive pressure ventilation in Minimal Invasive Surfactant Administration in Two Different Non-invasive Ventilation Modes to NRDS Infants, sponsored by Peking University Third Hospital. Terminated at 1 site in China. Open to participants aged 30 Minutes to 4 Months. Per ClinicalTrials.gov, last updated 2025-07-09.
Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment
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 11 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).
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.
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Infants who meet all of the following criteria will be included:
Exclusion Criteria
Infants who meet any of the following criteria will be excluded:
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%.
Other: Nasal continuous positive airway pressure
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.
Other: Non-invasive positive pressure ventilation
Preterm infants with spontaneous breathing are stabilized on non-invasive respiratory support (PEEP of 6 cmH2O and FiO2≤0.40) in the delivery room and during admission to NICU, and then randomly selected to start NCPAP within 30 minutes of birth. Under NCPAP, the calf pulmonary surfactant will be administered via MISA method within 120 minutes after birth if infants are clinically diagnosed with RDS.
Preterm infants with spontaneous breathing are stabilized on non-invasive respiratory support (PEEP of 6 cmH2O and FiO2≤0.40) in the delivery room and during admission to NICU, and then randomly selected to start NIPPV within 30 minutes of birth. Under NIPPV, the calf pulmonary surfactant will be administered via MISA method within 120 minutes after birth if infants are clinically diagnosed with RDS.
NIV treatment failure within the first 72 hours of life
The failure of non-invasive nasal respiratory support(NIPPV or NCPAP) within the first 72 hours of life
Time frame: From enrollment to the first 72 hours of life
NIV treatment failure within 7days after birth
The failure of non-invasive nasal respiratory support(NIPPV or NCPAP) within 7days after birth
Time frame: From enrollment to 7days after birth
Rate of pneumothorax
Rate of pneumothorax
Time frame: Through study completion and up to corrected three months
Rate of pulmonary hemorrhage
Rate of pulmonary hemorrhage
Time frame: Through study completion and up to corrected three months
Rate of hemodynamically significant patent ductus arteriosus (hsPDA)
Rate of hemodynamically significant patent ductus arteriosus (hsPDA)
Time frame: Through study completion and up to corrected three months
Rate of intraventricular hemorrhages (IVH, grade III or Ⅳ)
Rate of intraventricular hemorrhages (IVH, grade III or Ⅳ)
Time frame: Through study completion and up to corrected three months
Rate of periventricular leukomalacia
Rate of periventricular leukomalacia
Time frame: Through study completion and up to corrected three months
Rate of late-onset sepsis
Rate of late-onset sepsis
Time frame: Through study completion and up to corrected three months
Rate of bronchopulmonary dysplasia (BPD)
Rate of bronchopulmonary dysplasia (BPD)
Time frame: At 36 weeks PMA
Rate of necrotizing enterocolitis (NEC)
Rate of necrotizing enterocolitis (NEC)
Time frame: Through study completion and up to corrected three months
Rate of retinopathy of prematurity (ROP)
Rate of retinopathy of prematurity (ROP)
Time frame: Through study completion and up to corrected three months
Duration of non-invasive ventilation, IMV, and supplemental oxygen
Duration of non-invasive ventilation, duration of IMV, and days on supplemental oxygen
Time frame: Through study completion and up to corrected three months
Length of hospital stay
Length of hospital stay
Time frame: From enrollment to the end of treatment at an average of 8 weeks
Required>1 doses of surfactant
rate of required\>1 doses of surfactant
Time frame: From enrollment to 5 days after birth
In-hospital mortality
In-hospital mortality
Time frame: Through study completion and up to corrected three months
Pneumonia
rate of pneumonia
Time frame: Through study completion and up to corrected three months
Persistent pulmonary hypertension of newborn
rate of persistent pulmonary hypertension of newborn
Time frame: Through study completion and up to corrected three months
Plan to share: No
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Peking University Third Hospital