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Comparing higher versus standard pressure of nasal CPAP to prevent extubation failure in premature infants

Higher versus standard nCPAP for extubation failure in premature infants =32 weeks: a randomized controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160523028008N38
Enrollment
114
Registered
2026-04-29
Start date
2026-05-05
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Respiratory distress syndrome. Respiratory distress syndrome of newborn

Interventions

Intervention 1: Intervention group: Nasal Continuous Positive Airway Pressure (nCPAP) at higher level of 9 cmH2O. Infants receive nCPAP at 9 cmH2O immediately after extubation via nasal prongs or mask

Sponsors

Hamedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 1 Months

Inclusion criteria

Inclusion criteria: Gestational age =32 weeks Receiving mechanical ventilation via endotracheal tube First-time extubation to nCPAP Receipt of exogenous surfactant (if indicated per clinical protocol) Written informed consent obtained from parents or legal guardian

Exclusion criteria

Exclusion criteria: Major congenital anomaly Congenital heart disease (excluding ASD and PDA) Evidence of necrotizing enterocolitis (NEC) prior to surfactant administration Chromosomal disorders (e.g., Trisomy 13, 18, 21) Heart failure requiring treatment (inotropes or vasopressors)

Design outcomes

Primary

MeasureTime frame
Extubation failure. Timepoint: Within 96 hours after extubation. Method of measurement: Clinical examination and event recording.

Secondary

MeasureTime frame
Reintubation within 7 days after extubation. Timepoint: 7 days (168 hours) after extubation. Method of measurement: Clinical examination and medical record review.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFershthe Hajipour

Hamedan University of Medical Sciences

fhajipour87@gmail.com+98 916 360 0131

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026