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Comparison of Two Nasal CPAP Adjustment Methods After Extubation in Preterm Infants

Comparison of Nasal Continuous Positive Airway Pressure Titration Strategies after Extubation on Lung Function in Preterm Infants Using Electrical Impedance Tomography

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260102010
Enrollment
52
Registered
2026-01-02
Start date
2026-02-05
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Preterm infants, particularly those with very low birth weight, commonly experience respiratory insufficiency due to immature lung structure and reduced surfactant function. These infants often require invasive ventilation during the acute phase of respiratory distress. Following stabilization, extubation to nasal continuous positive airway pressure is routinely performed. However, extubation failure remains a significant clinical problem associated with increased morbidity, including the need f

Interventions

Nasal CPAP pressure will start at 6 cmH2O and increase every 30 minutes to 7 and 8 and 9 and 10 cmH2O. EIT data and vital signs will be recorded at each level.,Nasal CPAP pressure will start at 10 cmH
Experimental Device,Experimental Device
Incremental titration,Decremental titration

Sponsors

Siriraj Hospital Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 28 Days

Inclusion criteria

Inclusion criteria: 1. Gestational age less than 32 weeks OR birth weight less than 1500 grams. 2. First post-extubation period within the first 28 days of life. 3. FiO2 less than or equal to 0.40 and hemodynamically stable, defined as no high-dose inotropic support and no clinical shock. 4. Receiving nasal CPAP through nasal mask or short binasal prongs in accordance with unit standards. 5. Written informed consent obtained from both mother and father or a legally authorized representative.

Exclusion criteria

Exclusion criteria: 1. Severe congenital anomalies or structural abnormalities of the airway or lungs, such as congenital diaphragmatic hernia or cystic adenomatoid malformation. 2. Active and unstable air-leak syndrome, including pneumothorax requiring ongoing drainage. 3. Skin lesions or infection at the site required for EIT belt placement, preventing safe application of the device. 4. Any condition judged by the attending neonatologist to pose a safety risk for study participation.

Design outcomes

Primary

MeasureTime frame
End-expiratory lung impedance (EELI) measured by EIT at each CPAP level (6 to 10 cmH2O), comparing incremental vs decremental titration. At the end of each CPAP level during incremental or decremental titration, and at the final selected CPAP level. EELI measured using neonatal EIT belt with values recorded directly from the EIT monitor at each CPAP level.

Secondary

MeasureTime frame
Global Inhomogeneity (GI) Index At the end of each CPAP level and at the final selected CPAP level GI index measured by EIT,Center of Ventilation (CoV) At the end of each CPAP level and at the final selected CPAP level CoV measured by EIT,Extubation Failure within 72 Hours During the first 72 hours after extubation Need for reintubation ,Rate of bronchopulmonary dysplasia At 36 weeks postmentrual age Diagnosis based on oxygen requirement at 36 weeks postmenstrual age

Countries

Thailand

Contacts

Public ContactRatchada Kitsommart

Siriraj Hospital, Mahidol University

ratchada.kit@mahidol.ac.th0961715544

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026