Skip to content

Treatment of premature infants during spontaneous breathing

Clinical trial on the effectiveness of surfactant administration via a thin intratracheal catheter (Insure method) and intubation during spontaneous breathing in premature neonates.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016061328422N1
Enrollment
40
Registered
2016-06-20
Start date
2016-07-31
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 syndrome. Respiratory distress syndrome of newborn

Interventions

Intervention 1: Control group: Neonatal intubation and who are receiving100 mg/kg surfactants in 1-3 minutes via feeding tube. Intervention 2: Intervention group: Who are receiving 100 mg/kg surfactan
Treatment - Drugs
Control group: Neonatal intubation and who are receiving100 mg/kg surfactants in 1-3 minutes via feeding tube.
Intervention group: Who are receiving 100 mg/kg surfactant in 1-3 minutes from a feeding tube via a thin intratracheal catheter (Insure method) during spontaneous breathing.

Sponsors

Vice Chancellor for Research, Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 1 Days

Inclusion criteria

Inclusion criteria: Inclusion criteria: Premature infants with the respiratory distress syndrome; premature birth less than 32 weeks of gestational age; birth weight less than 1500 g. Exclusion criteria: Congenital anomalies; requiring mechanical ventilation after birth; infants with underlying disease (congenital infections, asphyxia, congenital cardiac defect).

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Duration of mechanical ventilation. Timepoint: 24 hours after intervention. Method of measurement: Day.

Secondary

MeasureTime frame
Morbidity and mortality rate in premature neonates. Timepoint: 24 hours after intervention. Method of measurement: Case.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHassan Boskabadi

Emam Reza Hospital

BoskabadiH@mums.ac.ir+98 51 3852 1121

Outcome results

None listed

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