Comparison of Intravenous Dexamethasone and Budesonide Nebulizer in treatment of Respiratory Distress Syndrome

Comparing the efficacy of Intravenous Dexamethasone and Budesonide Nebulizer in Infants Respiratory Distress Syndrome

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016101917413N20

Enrollment

Registered

2016-11-02

Start date

2014-06-22

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 of newborn. Respiratory distress syndrome of newborn

Interventions

Intervention 1: ?First group will undergo treatment with Intravenous Dexamethasone 0.15 mg/kg every 12 hours for 3 to 5 days. Intervention 2: The second group will undergo treatment with inhaler budes

Treatment - Drugs

?First group will undergo treatment with Intravenous Dexamethasone 0.15 mg/kg every 12 hours for 3 to 5 days

The second group will undergo treatment with inhaler budesonide through jet nebulizer (200 micrograms daily) for 3 to 5 days.

Eligibility

Sex/Gender

All

Age

1 Days to 1 Months

Inclusion criteria

Inclusion criteria: Inclusion criteria: birth weight between 1000-2500 gr;Gestational age of less than 36 weeks;Mechanical ventilation for at least two days;Oxygen saturation of more than 30% after extubation;PH55;PaO2<50 Exclusion Criteria:Hemorrhagic lesions;Congenital Anomalies;Chromosomal Anomalies;early sepsis;death before 72 hours of age

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Respiratory rate. Timepoint: before and after extubation. Method of measurement: one minute counting by nurse.;PH. Timepoint: before and after extubation. Method of measurement: Arterial Blood Gas Assessment.;Blood Pressure. Timepoint: before and after extubation. Method of measurement: Monitring System.;Oxygen Saturation. Timepoint: before and after extubation. Method of measurement: Pulse Oxymetry.	—

Measure

Time frame

Respiratory rate. Timepoint: before and after extubation. Method of measurement: one minute counting by nurse.;PH. Timepoint: before and after extubation. Method of measurement: Arterial Blood Gas Assessment.;Blood Pressure. Timepoint: before and after extubation. Method of measurement: Monitring System.;Oxygen Saturation. Timepoint: before and after extubation. Method of measurement: Pulse Oxymetry.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Hossein Khosravi

Student Research Committee, Baqiyatallah University of Medical Sciences, Tehran, Iran

dr.mhkhosravi@gmail.com+98 21 8862 0826

Outcome results

None listed

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