Comparison of Continuous Positive Airway Pressure (CPAP) and Non-Invasive Positive Pressure Ventilation (NIPPV) in Preterm Newborns With Respiratory Distress Syndrome. (NC3)

Vilnius University

Status: Enrolling

Conditions: Respiratory Distress Syndrome (RDS)

Treatments: Other: NIPPV; Other: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT06966752

NC3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: Under 44 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

CPAP

Active Comparator group

Description:

Patients under CPAP respiratory support.

Treatment:

Other: NIPPV

NIPPV

Experimental group

Description:

Patients under Noninvasive positive pressure ventilation (NIPPV).

Treatment:

Other: CPAP