Comparison of Continuous Positive Airway Pressure (CPAP) and Non-Invasive Positive Pressure Ventilation (NIPPV) in Preterm Newborns With Respiratory Distress Syndrome.
NCT ID: NCT06966752
Last Updated: 2025-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2025-03-25
2027-05-01
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CPAP
Patients under CPAP respiratory support.
NIPPV
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.
NIPPV
Patients under Noninvasive positive pressure ventilation (NIPPV).
CPAP
CPAP pressure of 6-8 mmH2O
Interventions
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NIPPV
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.
CPAP
CPAP pressure of 6-8 mmH2O
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Need of respiratory support (deemed by a clinician).
Exclusion Criteria
2. Cardiovascular instability
3. Consent refused or not provided
0 Minutes
44 Weeks
ALL
No
Sponsors
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Vilnius University
OTHER
Responsible Party
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Arunas Liubsys
Associate professor
Locations
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Vilnius University Santaros Klinikos
Vilnius, Vilnius County, Lithuania
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NC3
Identifier Type: -
Identifier Source: org_study_id
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