Respiratory Distress Syndrome (RDS)NC3NCT06966752
Comparison of Continuous Positive Airway Pressure (CPAP) and Non-Invasive Positive Pressure Ventilation (NIPPV) in Preterm Newborns With Respiratory Distress Syndrome.
A study testing NIPPV and CPAP in people with Respiratory Distress Syndrome (RDS), run by Vilnius University at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 minutes to 44 weeks
- Conditions the study is for
- Respiratory Distress Syndrome (RDS)
- What is being tested?
- NIPPV and CPAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteLithuania
- Study dates
- 25 Mar 2025to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 minutes to 44 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- Major congenital anomalies
- Cardiovascular instability
- Consent refused or not provided
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lithuania1 site, 1 recruiting
- Recruiting
Vilnius University Santaros Klinikos
Vilnius, Vilnius County, 08661
Arunas Liubsys, +37068722520, arunas.liubsys@santa.lt
Ernestas Virsilas, +37060787438, ernestas.virsilas@santa.lt
About this study
Official title: Randomized Control Trial: Nasal CPAP vs. NIPPV in Preterm Infants With Respiratory Distress Syndrome
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.
Read the 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.
- Conditions
- Respiratory Distress Syndrome (RDS)
- Being tested
- NIPPV, CPAP
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIPPVOther
Also called Noninvasive positive pressure ventilation
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.
CPAPOther
Also called Nasal Continuous Airway Pressure, nCPAP
CPAP pressure of 6-8 mmH2O
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Active comparator | Patients under CPAP respiratory support. Receives: Other: NIPPV |
| NIPPV | Experimental | Patients under Noninvasive positive pressure ventilation (NIPPV). Receives: Other: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
Need of intubation
Measured: 7 days
Secondary outcomes (5)
Secondary outcomes
Mortality rate
Measured: 44 weeks corrected gestational age
Secondary outcomes
Intubation rate
Measured: 7 days
Secondary outcomes
Late onset sepsis (LOS) rate
Measured: 44 weeks corrected gestational age
Secondary outcomes
Treatment duration
Measured: 44 weeks corrected gestational age
Secondary outcomes
Complication rates
Measured: 44 weeks corrected gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start25 Mar 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome (RDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arunas Liubsys, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966752
- Sponsor's protocol ID
- NC3
- Acronym
- NC3
- Status last verified
- May 2025
- First submitted
- 25 Mar 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial: Nasal CPAP vs. NIPPV in Preterm Infants With Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT06966752
- Acronym / sponsor ID
- NC3 / NC3
- Conditions
- Respiratory Distress Syndrome (RDS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP | Active comparator | Other: NIPPVPatients under CPAP respiratory support. |
| NIPPV | Experimental | Other: CPAPPatients under Noninvasive positive pressure ventilation (NIPPV). |
Who may qualify
- Ages
- 0 minutes to 44 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- Major congenital anomalies
- Cardiovascular instability
- Consent refused or not provided
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIPPVAlso: Noninvasive positive pressure ventilationNIPPV * 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. | Other | CPAP |
| CPAPAlso: Nasal Continuous Airway Pressure, nCPAPCPAP pressure of 6-8 mmH2O | Other | NIPPV |
Primary outcome
Treatment failure
Time frame: 7 days
Need of intubation
5 secondary outcomes
Secondary outcomes
Time frame: 44 weeks corrected gestational age
Secondary outcomes
Time frame: 7 days
Secondary outcomes
Time frame: 44 weeks corrected gestational age
Secondary outcomes
Time frame: 44 weeks corrected gestational age
Secondary outcomes
Time frame: 44 weeks corrected gestational age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIPPV and CPAP in people with Respiratory Distress Syndrome (RDS), run by Vilnius University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arunas Liubsys, Associate Professor (+370 6 872 2520, arunas.liubsys@santa.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.