Comparison of Continuous Positive Airway Pressure (CPAP)... | NCT06966752

Brief Title

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

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 25, 2025Actual

Primary Completion Date

May 1, 2027Estimated

Completion Date

May 1, 2027Estimated

First Submitted Date

Mar 25, 2025

First Submission Date that Met QC Criteria

May 7, 2025

First Posted Date

May 13, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2025

Last Update Posted Date

May 13, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Arunas Liubsys, Associate professor, Vilnius UniversityPrincipal Investigator

Lead Sponsor

Vilnius UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CPAP	Active Comparator	Patients under CPAP respiratory support.	Other: NIPPV
NIPPV	Experimental	Patients under Noninvasive positive pressure ventilation (NIPPV).	Other: CPAP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NIPPV	Other	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment failure	Need of intubation	7 days

Secondary Outcomes

Measure	Description	Time Frame
Secondary outcomes	Mortality rate	44 weeks corrected gestational age
Secondary outcomes	Intubation rate	7 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

Major congenital anomalies
Cardiovascular instability
Consent refused or not provided

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Minutes

Maximum Age

44 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Arunas Liubsys, Associate Professor	Contact	+370 6 872 2520		arunas.liubsys@santa.lt
Ernestas Virsilas	Contact	+37060787438		ernestas.virsilas@santa.lt

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vilnius University Santaros Klinikos	Recruiting	Vilnius	Vilnius County	08661	Lithuania

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

Masking Info

Masking

None (Open Label)

Masking Description

Not provided

Who Masked

Not provided

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

ID	Term
D011175	Positive-Pressure Respiration
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics
D012138	Respiratory Therapy