An interventional study of NIPPV and CPAP in Respiratory Distress Syndrome (RDS), sponsored by Vilnius University. Recruiting at 1 site in Lithuania. Open to participants aged 0 Minutes to 44 Weeks. Per ClinicalTrials.gov, last updated 2025-05-13.
Sponsored by Vilnius University · Not applicable, Interventional, and Treatment
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.
Treatment failure is defined as any of the following:
Secondary endpoints:
Pneumothorax rate Bronchopulmonary dysplasia (BPD) Necrotizing enterocolitis (NEC) Persisting ductus arteriosus (PDA) Intraventricular hemorrhage (IVH) Retinopathy of prematurity (ROP)
Nasal trauma:
Abdominal distension:
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.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
This study's planned enrollment of 150 is above the median of 60 across 822 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Vilnius University is the lead sponsor of 61 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Patients under CPAP respiratory support.
Other: NIPPV
Patients under Noninvasive positive pressure ventilation (NIPPV).
Other: CPAP
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.
Also known as: Noninvasive positive pressure ventilation
CPAP pressure of 6-8 mmH2O
Also known as: Nasal Continuous Airway Pressure, nCPAP
Treatment failure
Need of intubation
Time frame: 7 days
Secondary outcomes
Mortality rate
Time frame: 44 weeks corrected gestational age
Secondary outcomes
Intubation rate
Time frame: 7 days
Secondary outcomes
Late onset sepsis (LOS) rate
Time frame: 44 weeks corrected gestational age
Secondary outcomes
Treatment duration
Time frame: 44 weeks corrected gestational age
Secondary outcomes
Complication rates
Time frame: 44 weeks corrected gestational age
Plan to share: No
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Respiratory Distress Syndrome →
Vilnius University