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RAM canula nCPAP Efficiency in RDS Management

nCPAP Failure in RDS Management Using RAM Canula Versus Short Binasal Prongs in Preterm Infants (with 28-32 Weeks of Gestation): a Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20120728010430N13
Enrollment
70
Registered
2025-05-08
Start date
2025-06-05
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Surfactant deficiency in the lungs causes this medical condition.. Respiratory distress syndrome of newborn

Interventions

Intervention 1: Intervention group: Respiratory support through RAM Canula produced by Neotech Corporation. It is available in three sizes suitable for a variety of nostril sizes to fit the patients n

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 1 Days

Inclusion criteria

Inclusion criteria: Neonates with a gestational age of 28-32 weeks Clinical symptoms associated with RDS (tachypnea, intercostal retraction, nasal flaring, grunting, need for FiO2 higher than 21%

Exclusion criteria

Exclusion criteria: Major congenital malformations Weak respiratory effort accompanied by apnea or the need for mechanical ventilation in the NICU at admission signs consistent with shock, pulmonary hemorrhage, the probability of persistent pulmonary hypertension severe respiratory acidemia (pH60 mm Hg) severe metabolic acidemia (pH10 mEq/L)

Design outcomes

Primary

MeasureTime frame
Assessment of the need for invasive mechanical ventilation (nCPAP failure) withing 72 hours of birth. Timepoint: 72 hours after birth. Method of measurement: Analysis of 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