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Nasal Continuous Positive Airway Pressure-Assisted Neonatal Oral-Endotracheal Intubation: Protocol for a Randomized Controlled Trial

Nasal Continuous Positive Airway Pressure-Assisted Neonatal Oral-Endotracheal Intubation: Protocol for a Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121468
Enrollment
Unknown
Registered
2026-03-31
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Respiratory failure requiring intubation

Interventions

Standard care group:standard care
nCPAP group:nasal Continuous Positive Airway Pressure-assisted neonatal oral-endotracheal intubation

Sponsors

West China Second University Hospital of Sichuan University (WCSUH- SCU)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1.Receiving non-invasive respiratory support; 2.Undergoing non-emergency oral endotracheal intubation in the NICU; 3.The guardian agrees.

Exclusion criteria

Exclusion criteria: 1.Requiring emergency endotracheal intubation; 2.Absence of spontaneous breathing; 3.Contraindications to non-invasive ventilation use, including but not limited to air leakage syndrome, congenital nasal deformity, congenital diaphragmatic hernia; 4.Cyanotic congenital heart disease or arrhythmia; 5.Difficult airway assessed by the treating clinician; 6.Infant with suspected or proven respiratory infectious disease such as COVID-19 or tuberculosis, etc; 1.or born to a mother with suspected or proven respiratory infectious disease; 7.Fatal severe deformity; 8.Guardian refuses.

Design outcomes

Primary

MeasureTime frame
the magnitude of SpO2 decline during first intubation;—

Secondary

MeasureTime frame
Incidence of bradycardia (HR<100 bpm) during the first intubation attempt;Duration of bradycardia (HR <100bpm) during first intubation attempt (seconds);Total duration of all intubation attempts (successful and unsuccessful) (seconds);Time to bradycardia (HR <100bpm) during the first intubation attempt (seconds);Duration of desaturation (SpO2 < 90%) during first intubation attempt (seconds);Number of intubation attempts;Incidence of first intubation attempt success;Time to desaturation (SpO2 < 90%) during the first intubation attempt (seconds);Duration of the first intubation success (seconds);Incidence of desaturation (SpO2 < 90%) during the first intubation attempt;—

Countries

China

Contacts

Public ContactTao Xiong

West China Second University Hospital of Sichuan University (WCSUH- SCU)

tao_xiong@126.com+86 181 8060 9297

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026