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Study of the effect of surfactant in respiratory distress of preterm neonates

Comparison of the effect of minimally invasive surfactant therapy (MIST) vs Intubation, Surfactant administration and Extubation (INSURE) method in neonatal respiratory distress of preterm neonates with 34 weeks or less

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014080716937N4
Enrollment
50
Registered
2017-07-27
Start date
2013-04-01
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

Respiratory distress of newborn. Respiratory distress of newborn, unspecified

Interventions

Intervention 1: participants take 200 mg/kg surfactant by MIST method. Intervention 2: participants take 200 mg/kg surfactant by INSUR method.
Treatment - Drugs
participants take 200 mg/kg surfactant by MIST method
participants take 200 mg/kg surfactant by INSUR method

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Months

Inclusion criteria

Inclusion criteria: Inclusion criteria: preterm neonates with 34 week age or less; respiratory distress due to surfactant deficiency; Exclusion criteria: parents have not consent with incorporating in study; neonate with asphyxia; neonates with intubation from the birth; respiratory distress not due to RDS; neonates with maternal abnormality

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Need for second dose surfactant. Timepoint: Per 6 hour after intervention. Method of measurement: Chart.;Apnea. Timepoint: During hospitalization. Method of measurement: Visit.;Duration of Oxygen Consumption. Timepoint: Per 6 hour after intervention. Method of measurement: Chart.

Secondary

MeasureTime frame
Complications of surfactant injection (Coughing or Gagging, Pneumothorax, Surfactant Reflux, Bradycardia, Pulmonary Hemorrhage, Intra ventricular Hemorrhage (>grade 2)). Timepoint: Per 6 hour after intervention. Method of measurement: Chart and visit.;The rate of intubated in First 72 h of Life. Timepoint: Per 6 hour after intervention. Method of measurement: Chart.;Length of Stay in NICU. Timepoint: Per 6 hour after intervention. Method of measurement: Chart.;Death. Timepoint: During hospitalization. Method of measurement: Chart.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZohreh Farsi

Tehran University of Medical Sciences (Arash hospital)

sh.farsi@yahoo.com+98 21 7788 3284

Outcome results

None listed

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