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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06966752
Acronym
NC3
Enrollment
150
Registered
2025-05-13
Start date
2025-03-25
Completion date
2027-05-01
Last updated
2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome (RDS)

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.

Interventions

OTHERNIPPV

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.

OTHERCPAP

CPAP pressure of 6-8 mmH2O

Sponsors

Vilnius University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Minutes to 44 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Treatment failure7 daysNeed of intubation

Secondary

MeasureTime frameDescription
Secondary outcomes44 weeks corrected gestational ageMortality rate

Countries

Lithuania

Contacts

Primary ContactArunas Liubsys, Associate Professor
arunas.liubsys@santa.lt+370 6 872 2520
Backup ContactErnestas Virsilas
ernestas.virsilas@santa.lt+37060787438

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026