NCT06966752

Comparison of Continuous Positive Airway Pressure (CPAP) and Non-Invasive Positive Pressure Ventilation (NIPPV) in Preterm Newborns With Respiratory Distress Syndrome.

Randomized Control Trial: Nasal CPAP vs. NIPPV in Preterm Infants With Respiratory Distress Syndrome

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Vilnius University · Academic / Other
• Sex: All
• Age: 0 Minutes – 44 Weeks
• Healthy volunteers: Not accepted

Summary

Primary objective: to evaluate safety and efficacy of two different non-invasive respiratory support modalities in preterm neonatal patients with respiratory distress syndrome. Secondary objective is to compare different respiratory support mode performance in different gestational age groups. Primary endpoint is treatment failure. With this study, the following hypotheses will be tested: Hypothesis 1: NIPPV has a lower failure rate compared to CPAP mode. Hypothesis 2: NIPPV complication rate is non-superior compared to CPAP.

Detailed description

Treatment failure is defined as any of the following: * FiO2\>0.6 to maintain SpO2\>88% * Respiratory acidosis (pH\<7.2, pCO2\>65 mmHg) * recurrent apnea (\>4 episodes/h) or apnea requiring bag and mask ventilation * Silverman Andersen respiratory severity score (SAS score) ≥6 and does not improve by \> 20% within 4-8 hours Secondary endpoints: * Mortality rate * Intubation rate * Late onset sepsis (LOS) rate * Treatment duration * Complication rates: Pneumothorax rate Bronchopulmonary dysplasia (BPD) Necrotizing enterocolitis (NEC) Persisting ductus arteriosus (PDA) Intraventricular hemorrhage (IVH) Retinopathy of prematurity (ROP) Nasal trauma: * I° - nasal/septal redness * II° - nasal/septal redness + indent * III° - nasal/septal redness + indent + skin breakdown Abdominal distension: * Visible abdominal distension (defined by attending clinician) AND one of the following: * Feeding intolerance (defined by clinician) OR * \>3 desaturation episodes or \>20% FiO2 increase in 1 hour after feed. With this study, the following hypotheses will be tested: Hypothesis 1: NIPPV has a lower failure rate compared to CPAP mode. Hypothesis 2: NIPPV complication rate is non-superior compared to CPAP.

Conditions

• Respiratory Distress Syndrome (RDS)

Interventions

Type	Name	Description
OTHER	NIPPV	NIPPV * PEEP 6-8 cmH2O * PIP: 14-16 cmH2O * Tinsp: 0.3-0.5sec * \<28 weeks GA: 0.3 - 0.4 sec * \>28weeks GA: 0.4 - 0.5 sec * Rate: 20-35 breaths per minute.
OTHER	CPAP	CPAP pressure of 6-8 mmH2O

Timeline

• Start date: 2025-03-25
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2025-05-13
• Last updated: 2025-05-13

Locations

1 site across 1 country: Lithuania