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The Efficacy of Non-invasive Oscillatory-PAP in the Management of RDS

The Efficacy of Non-invasive Oscillatory-PAP in the Management of RDS in Infants with a Gestational Age of 26 to 30 Weeks: A Comparative Clinical Trial of Seattle-PAP vs. Bubble-CPAP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20120728010430N14
Enrollment
70
Registered
2025-09-26
Start date
2025-12-22
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Shortage of surfactant causes RDS in neonates.. Respiratory distress syndrome of newborn

Interventions

Intervention 1: Control group: Neonates assigned to the bubble-CPAP group will receive nCPAP via appropriately sized nasal prongs (Fisher & Paykel Healthcare, Auckland, New Zealand). Continuous disten

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 1 Days

Inclusion criteria

Inclusion criteria: Newborns with a range of 26 to 30 weeks of gestation Clinical symptoms associated with RDS (tachypnea, intercostal retraction, nasal flaring, grunting, need for FiO2 higher than 21%

Exclusion criteria

Exclusion criteria: Major congenital malformations (congenital diaphragmatic hernia, tracheoesophageal fistula, Pierre Robin sequence, choanal atresia) Possibility of chromosomal abnormalities Weak respiratory effort, which may be accompanied by apnea or require invasive ventilation during NICU admission Manifestations of shock, pulmonary hemorrhage, or the possibility of persistent pulmonary hypertension Severe respiratory acidosis (pH60 mm Hg) Severe metabolic acidosis (pH10 mEq/L)

Design outcomes

Primary

MeasureTime frame
Investigating the need for invasive mechanical ventilation (nCPAP failure) within 72 hours of birth in the management of Respiratory Distress Syndrome in neonates with the gestational age of 26-30 weeks: Comparing Seattle PAP vs. Bubble-CPAP. Timepoint: 72 hours. Method of measurement: Investigating arterial blood gases.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Sadeghnia

Esfahan University of Medical Sciences

sadeghnia@med.mui.ac.ir+98 31 3335 1777

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026