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

Not Applicable

Recruiting

• Conditions: Respiratory Distress Syndrome (RDS)

• Registration Number: NCT06966752
• Lead Sponsor: Vilnius University

Brief 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.

Study Timeline

• Study Start: 2025-03-25
• Study First Submitted: 2025-03-25
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-07
• Last Update Submitted: 2025-05-07
• Study First Posted: 2025-05-13
• Last Update Posted: 2025-05-13
• Primary Completion: 2027-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. gestational age (GA) between 22+0 and 34+6 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings).
2. Need of respiratory support (deemed by a clinician).

Exclusion Criteria

1. Major congenital anomalies
2. Cardiovascular instability
3. Consent refused or not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Treatment failure	7 days	Need of intubation

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes	44 weeks corrected gestational age	Complication rates

Trial Locations

Locations (1)

Vilnius University Santaros Klinikos; 🇱🇹 Vilnius, Lithuania