Clinical trial NCT06966752: Comparison of Continuous Positive Airway Pressure (CPAP) and Non-Invasive Positive Pressure Ventilation (NIPPV) in Preterm Newborns With Respiratory Distress Syndrome.
Official title: Randomized Control Trial: Nasal CPAP vs. NIPPV in Preterm Infants With Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Distress Syndrome (RDS)
Lead sponsor: Vilnius University
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 150
Sex: ALL
Minimum age (years): 0
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment failure
timeFrame: 7 days
Secondary outcomes:
measure: Secondary outcomes
timeFrame: 44 weeks corrected gestational age
measure: Secondary outcomes
timeFrame: 7 days
measure: Secondary outcomes
timeFrame: 44 weeks corrected gestational age
measure: Secondary outcomes
timeFrame: 44 weeks corrected gestational age
measure: Secondary outcomes
timeFrame: 44 weeks corrected gestational age
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University Santaros Klinikos
Study officials:
References: