Comparing surfactant administration without intubation with conventional method

Comparing outcome of surfactant administration via tracheal catheterization during spontaneous breathing (tec-care) with tracheal intubation accompany with positive pressure ventilation (INSURE) in premature neonates with respiratory distress syndrome.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201112078314N1

Enrollment

180

Registered

2013-01-14

Start date

2012-08-22

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

Respiratory distress syndrome. Respiratory distress syndrome of newborn

Interventions

Intervention 1: Clinical guideline for administering surfactant viaTEC-CARE: 1. NCPAP pressure should be increased as much as 8 to 10 cmh2o 2. In order to decrease secretions of the neonate we admini

Treatment - Devices

Clinical guideline for administering surfactant viaTEC-CARE: 1. NCPAP pressure should be increased as much as 8 to 10 cmh2o 2. In order to decrease secretions of the neonate we administer atropin 5

Clinical Guide line for administering surfactant via INSURE: 1.Neonates are removed from NCPAP. 2. Before intubation 2µg / kg Fentanylwas injected for Sedation 3. Neonate is intubated with endot

Eligibility

Sex/Gender

All

Age

27 Years to 36 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Neonates with gestational age of 27-36 weeks with respiratory distress syndrome that required surfactant administration; Delivered in Multi center hospitals of (Alzahra and 29 bahman from Tabriz; Ommolbanin from Mashhad and Shahid Beheshti from Esfehan); Were resuscitated according to resuscitation guide line 2006 .Exclusion criteria: Neonates with congenital disease ;Apgar score of less than 6 within 5 minutes .

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Continuous positive airway pressure failure. Timepoint: Half-Hour after intervention. Method of measurement: Increasing respiratory distress syndrome score.	—

Secondary

Measure	Time frame
Duration of hospitalization. Timepoint: Time of discharge from hospital. Method of measurement: Extracted from the file.;Intraventriculal hemorrhage. Timepoint: 7th day after birth. Method of measurement: Cranial ultrasonography by a radiologist.;Chronic lung disease. Timepoint: 36th week of gestational age. Method of measurement: Observation of hospital file for oxygen requirment at 36th weeks of postconceptional age.	—

Measure

Time frame

Duration of hospitalization. Timepoint: Time of discharge from hospital. Method of measurement: Extracted from the file.;Intraventriculal hemorrhage. Timepoint: 7th day after birth. Method of measurement: Cranial ultrasonography by a radiologist.;Chronic lung disease. Timepoint: 36th week of gestational age. Method of measurement: Observation of hospital file for oxygen requirment at 36th weeks of postconceptional age.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Kayvan Mirnia

Alzahra hospital

kmirnia@yahoo.com+98 41 1553 7493

Outcome results

None listed

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