Comparative study of the effect of intratracheal administration of Braksurf with curosurf on outcomes of neonates with respiratory distress syndrome admitted in intensive care unit of Kamali hospital in 2019-2020

Comparative study of the effect of intratracheal administration of Braksurf with curosurf on outcomes of neonates with respiratory distress syndrome admitted in intensive care unit

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170427033661N2

Enrollment

100

Registered

2020-12-16

Start date

2020-12-21

Completion date

Unknown

Last updated

2025-10-13

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: Intervention group: (Braxorf) Surfactant manufactured by Teximadaru Company (with an initial dose of 4 cc per kilogram of body weight, repeat each dose for 6 to 12 hours, if necessary,

Eligibility

Sex/Gender

All

Age

1 Days to 28 Days

Inclusion criteria

Inclusion criteria: Infants with respiratory distress Pregnancy equal to and more than 25 weeks to equal to 37 weeks Admission up to 8 hours after birth Requires fio2 over 30%

Exclusion criteria

Exclusion criteria: Severe asphyxia at birth Apgar 5 minutes less than 6 Diagnosis of congenital major abnormalities such as heart disease and severe life-threatening abnormalities Multiple anomalies ?Early malignant toxic sepsis Rupture of embryonic membranes for more than 18 hours

Design outcomes

Primary

Measure	Time frame
Length of hospital stay. Timepoint: End of the study. Method of measurement: Patient documentation.	—

Secondary

Measure	Time frame
Duration requires mechanical ventilation. Timepoint: Patient discharge. Method of measurement: Hospital documentations.;Blood PH. Timepoint: The first 24 and 48 hours of life. Method of measurement: Based on arterial or venous blood samples.;HCO3. Timepoint: The first 24 and 48 hours of life. Method of measurement: Based on arterial or venous blood samples.;Pco2. Timepoint: The first 24 and 48 hours of life. Method of measurement: Based on arterial or venous blood samples.;Sepsis. Timepoint: ??? ??????. Method of measurement: General malaise with tachypnea / hypotension / unstable vital signs / positive blood or csf culture.;IVH. Timepoint: End of study. Method of measurement: Occurrence of intraventricular hemorrhage.;BPD. Timepoint: End of study. Method of measurement: Occurrence of oxygen dependence after 28 days.;Pneumothorax. Timepoint: End of study. Method of measurement: Occurrence of pneumothorax after injection by radiography.;Vital signs. Timepoint: Every 4 hours during the first 72 hours of a baby's life. Method of measurement: Measurement of heart rate, respiration rate, blood pressure and temperature.;Death. Timepoint: End of study. Method of measurement: Infant death.;Drug side effects. Timepoint: End of study. Method of measurement: Based on examination and history.	—

Measure

Time frame

Duration requires mechanical ventilation. Timepoint: Patient discharge. Method of measurement: Hospital documentations.;Blood PH. Timepoint: The first 24 and 48 hours of life. Method of measurement: Based on arterial or venous blood samples.;HCO3. Timepoint: The first 24 and 48 hours of life. Method of measurement: Based on arterial or venous blood samples.;Pco2. Timepoint: The first 24 and 48 hours of life. Method of measurement: Based on arterial or venous blood samples.;Sepsis. Timepoint: ??? ??????. Method of measurement: General malaise with tachypnea / hypotension / unstable vital signs / positive blood or csf culture.;IVH. Timepoint: End of study. Method of measurement: Occurrence of intraventricular hemorrhage.;BPD. Timepoint: End of study. Method of measurement: Occurrence of oxygen dependence after 28 days.;Pneumothorax. Timepoint: End of study. Method of measurement: Occurrence of pneumothorax after injection by radiography.;Vital signs. Timepoint: Every 4 hours during the first 72 hours of a baby's life. Method of measurement: Measurement of heart rate, respiration rate, blood pressure and temperature.;Death. Timepoint: End of study. Method of measurement: Infant death.;Drug side effects. Timepoint: End of study. Method of measurement: Based on examination and history.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Alireza Jashni Motlagh

Alborz University of Medical Sciences

dr.jashnimotlagh@abzums.ac.ir+98 26 3222 2021

Outcome results

None listed

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