Comparison of Continuous Positive Airway Pressure (CPAP) and Non-Invasive Positive Pressure Ventilation (NIPPV) in Preterm Newborns With Respiratory Distress Syndrome.
NC3
Randomized Control Trial: Nasal CPAP vs. NIPPV in Preterm Infants With Respiratory Distress Syndrome
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2025
CompletedStudy Start
First participant enrolled
March 25, 2025
CompletedFirst Posted
Study publicly available on registry
May 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
May 13, 2025
May 1, 2025
2.1 years
March 25, 2025
May 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment failure
Need of intubation
7 days
Secondary Outcomes (5)
Secondary outcomes
44 weeks corrected gestational age
Secondary outcomes
7 days
Secondary outcomes
44 weeks corrected gestational age
Secondary outcomes
44 weeks corrected gestational age
Secondary outcomes
44 weeks corrected gestational age
Study Arms (2)
CPAP
ACTIVE COMPARATORPatients under CPAP respiratory support.
NIPPV
EXPERIMENTALPatients under Noninvasive positive pressure ventilation (NIPPV).
Interventions
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.
Eligibility Criteria
You may qualify if:
- gestational age (GA) between 22+0 and 34+6 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings).
- Need of respiratory support (deemed by a clinician).
You may not qualify if:
- Major congenital anomalies
- Cardiovascular instability
- Consent refused or not provided
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vilnius University Santaros Klinikos
Vilnius, Vilnius County, 08661, Lithuania
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
March 25, 2025
First Posted
May 13, 2025
Study Start
March 25, 2025
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
May 13, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share