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The effect of more radiant ventilation compared to conventional mechanical ventilation as an initial invasive respiratory intervention on reducing the duration of mechanical ventilation in preterm infants with respiratory failure

Evaluation of the effect of more radiant ventilation compared to conventional mechanical ventilation as an initial invasive respiratory intervention on reducing the duration of mechanical ventilation in preterm infants with respiratory distress syndrome with respiratory failure

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130329012869N3
Enrollment
50
Registered
2022-02-12
Start date
2022-01-21
Completion date
Unknown
Last updated
2022-03-08

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

Conditions

Infants with respiratory distress syndrome with respiratory failure. Respiratory distress syndrome of newborn

Interventions

Intervention 1: Intervention group 1: Infants with respiratory failure on high-frequency oscillatory ventilation(HFOV) with initial mean airway pressure(MAP) setting are typically in the range of main

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 7 Days

Inclusion criteria

Inclusion criteria: Premature infants less than or equal to 37 weeks of gestational age are admitted to the NICU Diagnosis of Respiratory Distress Syndrome (RDS) based on clinical and radiological evidence While supported under NCPAP, according to European consensus guideline criteria, they have been prescribed surfactant by INSURE method Requires invasive mechanical ventilation due to respiratory failure Intubated for the first time Parents' consent to participate in the study

Exclusion criteria

Exclusion criteria: Intubation due to diagnosis other than Respiratory Distress Syndrome (RDS) Under mechanical ventilation with initial embedded mode less than 12 hours Change the infant mechanical ventilation mode from HFOV to Conventional or vice versa during treatment Positive blood culture at birth Existence of congenital major anomalies that affect the baby's breathing (such as severe pulmonary hypoplasia, congenital lung abnormalities, congenital airway obstruction) Birth weight less than 600 gr Having cyanotic heart disease Definitive diagnosis of coronavirus (PCR positive) in mother or infant

Design outcomes

Primary

MeasureTime frame
Days requiring mechanical ventilation. Timepoint: During the study. Method of measurement: Observation.;Duration of oxygen requirement. Timepoint: During the study. Method of measurement: Observation.;Duration of hospitalization. Timepoint: During the study. Method of measurement: Observation.

Secondary

MeasureTime frame
Sepsis. Timepoint: During the study. Method of measurement: Clinical observation.;Pulmonary hemorrhage. Timepoint: During the study. Method of measurement: Clinical observation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZohreh Badiee

Esfahan University of Medical Sciences

badiee@med.mui.ac.ir+98 31 3792 4572

Outcome results

None listed

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