Comparing the efficacy of intravenous Dexamethasone and Inhaler N-Acetyl Cysteine plus intravenous Dexamethasone in treatment of Respiratory Distress Syndrome

Comparing the efficacy of intravenous Dexamethasone and N-Acetyl Cysteine nebulizer plus intravenous Dexamethasone in treatment of Respiratory Distress Syndrome

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016101917413N21

Enrollment

Registered

2016-11-03

Start date

2015-05-22

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 N-Ace

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 N-Acetyl Cysteine through jet nebulizer (400 mg every 8 hours) 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