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Comparing two types of noninvasive mechanical ventilation in neonatal respiratory distress after surfactant replacement therapy

Comparing High flow nasal cannula versus nasal CPAP for INSURE treatment of neonatal respiratory distress syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201201228800N1
Enrollment
54
Registered
2012-08-11
Start date
2012-07-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

INSURE in Neonatal Respiratory Distress Syndrome. Respiratory distress syndrome of newborn

Interventions

Intervention 1: control group: intubation, surfactant replacemnt therapy, extubation to NCPAP. Intervention 2: Case group: intubation, surfactant replacemnt therapy, extubation to HFNC.
Treatment - Drugs
control group: intubation, surfactant replacemnt therapy, extubation to NCPAP
Case group: intubation, surfactant replacemnt therapy, extubation to HFNC

Sponsors

Maternal, Fetal & Neonatal Research Center, Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 28 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: preterm infants with respiratory distress; need for surfactant therapy; gestational age 28-34 wks; parental written consent. Exclusion criteria: babies with major congenital anomalies; congenital heart disease; asphyxia with apgar score less than 5 in 5 minutes.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Reintubation. Timepoint: after intervention till 3 days. Method of measurement: ABG assessment and RDS score and FIO2 requirment.

Secondary

MeasureTime frame
Duration of oxygen therapy. Timepoint: after intervention till discharge. Method of measurement: day.;Amount of oxygen therapy. Timepoint: after intervention. Method of measurement: fraction of oxygen.;Survival. Timepoint: after intervention till discharge. Method of measurement: alive or death.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahin Nariman MD

Tehran University of Medical Sciences

shaahin_nariman@yahoo.com+98 21 7788 3284

Outcome results

None listed

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