A Comparative Study of Concomitant Intratracheal Administration of Surfactant with Budesonide with Surfactant alone in Premature Infants with Respiratory Distress Syndrome.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20201222049802N1

Enrollment

134

Registered

2021-02-28

Start date

2021-01-04

Completion date

Unknown

Last updated

2021-04-26

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

Conditions

Respiratory distress syndrome of newborn. Respiratory distress syndrome of newborn

Interventions

Intervention 1: Intervention group: hospitalized infants receive 2.5 cc/kg Curosurf vial in combination with 1 cc/kg Pulmicort inhaler solution. Curosurf is a natural surfactant. each vial of Curosur

Eligibility

Sex/Gender

All

Age

No minimum to 3 Days

Inclusion criteria

Inclusion criteria: Premature Infant Less than 37 week's with Moderate or severe RDS Weight less than 2500 grams Requires Mechanical Ventilation Requires FiO2 more than 30% at Gestational age under 28 week's and more than 40% at Gestational age more than 28 week's.

Exclusion criteria

Exclusion criteria: Weight Less than 700 grams Severe Congenital Anomalies Fatal Cardiopulmonary Disease Other causes for Respiratory Distress Include Congenital Diaphragmatic Hernia

Design outcomes

Primary

Measure	Time frame
Incidence of death. Timepoint: Incidence of death from admission to hospital discharge. Method of measurement: Physical examination.;Incidence of Bronchopulmonary Dysplasia. Timepoint: Evaluation of Diagnostic criteria of Bronchopulmonary Dysplasia at 14 and 28 days after the start of the study. Method of measurement: Evaluation of Diagnostic criteria.;Duration of hospitalization. Timepoint: At the time of discharge from the hospital. Method of measurement: Count the number of hospitalization days.;Duration requires Mechanical ventilation. Timepoint: From patient admission to hospital discharge. Method of measurement: Count the days required for a mechanical ventilation.;Incidence of Pneumothorax. Timepoint: From patient admission to hospital discharge. Method of measurement: Clinical observation and chest x ray.;Incidence of pulmonary hemorrhage. Timepoint: From patient admission to hospital discharge. Method of measurement: Clinical observation and chest x ray.;Incidence of Intraventricular hemorrhage. Timepoint: At 7, 14 and 30 days if hospitalized. Method of measurement: Brain Sonography.;Oxygen index on the first and third day of treatment. Timepoint: the first and third day of treatment. Method of measurement: Calculated using the formula. Mean airway pressure multiplied by fraction of Inspired oxygen divided by arterial oxygen pressure multiplied by 100.;Mean airway pressure on the first and third day of treatment. Timepoint: the first and third day of treatment. Method of measurement: Using the number calculated by the Ventilator.;Need the next dose of Surfactant. Timepoint: The first three days of hospitalization. Method of measurement: Record patient file information.;Mean systolic and diastolic blood pressure. Timepoint: The first and third day of treatment. Method of measurement: Using an oscillometric barometer attached to the monitor.;Blood Sugar level. Timepoint: The first and third day of treatment. Method of measurement: Using a Glucometer.	—

Measure

Time frame

Incidence of death. Timepoint: Incidence of death from admission to hospital discharge. Method of measurement: Physical examination.;Incidence of Bronchopulmonary Dysplasia. Timepoint: Evaluation of Diagnostic criteria of Bronchopulmonary Dysplasia at 14 and 28 days after the start of the study. Method of measurement: Evaluation of Diagnostic criteria.;Duration of hospitalization. Timepoint: At the time of discharge from the hospital. Method of measurement: Count the number of hospitalization days.;Duration requires Mechanical ventilation. Timepoint: From patient admission to hospital discharge. Method of measurement: Count the days required for a mechanical ventilation.;Incidence of Pneumothorax. Timepoint: From patient admission to hospital discharge. Method of measurement: Clinical observation and chest x ray.;Incidence of pulmonary hemorrhage. Timepoint: From patient admission to hospital discharge. Method of measurement: Clinical observation and chest x ray.;Incidence of Intraventricular hemorrhage. Timepoint: At 7, 14 and 30 days if hospitalized. Method of measurement: Brain Sonography.;Oxygen index on the first and third day of treatment. Timepoint: the first and third day of treatment. Method of measurement: Calculated using the formula. Mean airway pressure multiplied by fraction of Inspired oxygen divided by arterial oxygen pressure multiplied by 100.;Mean airway pressure on the first and third day of treatment. Timepoint: the first and third day of treatment. Method of measurement: Using the number calculated by the Ventilator.;Need the next dose of Surfactant. Timepoint: The first three days of hospitalization. Method of measurement: Record patient file information.;Mean systolic and diastolic blood pressure. Timepoint: The first and third day of treatment. Method of measurement: Using an oscillometric barometer attached to the monitor.;Blood Sugar level. Timepoint: The first and third day of treatment. Method of measurement: Using a Glucometer.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAsghar Marzban

Zanjan University of Medical Sciences

Drmarzban@zums.ac.ir+98 24 3342 0651

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 8, 2026