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The efficacy of Proportional Assist Ventilation in Managing Respiratory Distress Syndrome

Proportional assist ventilation versus volume-targeted ventilation in managing respiratory distress syndrome in pre-term infants following CPAP failure: a clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20120728010430N15
Enrollment
70
Registered
2025-10-29
Start date
2025-11-03
Completion date
Unknown
Last updated
2025-12-08

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: Control group: Following nCPAP failure, neonates enter the ACV group where these criteria will be defined for them: TV=4-6 mL/kg, Trigger=0.1 l/min? PEEP=5-8 cm H2O? Ti=0.3-0.35 second
resistive unloading=30 cmH2O/L/s for tracheal tube 2.5 mm ID
resistive unloading=20 cmH2O/L/s for tracheal tube 3 mm ID
neonates' compliance will be assessed during 6 spontaneous breaths, whose average will be considered as elastic unloading with the reverse proportion
the average resistance will also be monitored. If the average data reaches values higher than 25 cmH2O/L/s, the level of resistive unloading will be increased to obtain resistance values of lower than

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 1 Days

Inclusion criteria

Inclusion criteria: Newborns with an age range of 26-32 weeks of gestation receiving nCPAP as well as surfact through INSURE method within 2 hours of birth due to the clinical and radiologic symptoms of RDS Filling out the written consent form

Exclusion criteria

Exclusion criteria: Evidence of chromosomal or genetic abnormalities Significant congenital anomalies or malformations Any contraindication that limits the implementation of non-invasive ventilation (NIV), such as the need for surgical interventions involving the gastrointestinal system Evidence suggestive of perinatal asphyxia, defined as the presence of at least one or two of the following criteria: Apgar score less than 6 at 10 minutes after birth, or the need for positive pressure ventilation and/or chest compressions in conjunction with positive pressure ventilation within 10 minutes of life; any acute perinatal sentinel event resulting in hypoxic-ischemic encephalopathy (HIE), such as placental abruption, umbilical cord prolapse, or severe fetal heart rate abnormalities; umbilical cord blood (or arterial sample taken within the first hour after birth) with pH<7 or base excess (BE)=-16 mmol/L

Design outcomes

Primary

MeasureTime frame
The need for High Frequency Ventilation in neonates with RDS in PAV and ACV groups following nCPAP failure. 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