The effect of inhalant budesonide with surfactant prescription in the treatment of respiratory distress syndrome in premature infants

Comparison of intratracheal injection of surfactants with and without prescription of inhalant budesonide on the clinical course of premature newborns weighing less than 1500 grams with respiratory distress syndrome in the neonatal intensive care unit. A randomized clinical trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017053034219N1

Enrollment

Registered

2017-07-20

Start date

2017-06-10

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

neonatal respiratory distress syndrome. Respiratory distress of newborn

Interventions

Intervention 1: In the intervention group: budesonide (Pulmicort vials, product of Astrazenca Co., Canada) 0.25 mg / kg as endotracheal nebulizer immediately after standard treatment. Intervention 2:

Treatment - Drugs

In the intervention group: budesonide (Pulmicort vials, product of Astrazenca Co., Canada) 0.25 mg / kg as endotracheal nebulizer immediately after standard treatment

The standard treatment control group: Curosurf surfactant Manufactured by Cheisi Co., Italy, at a rate of 2.5 ml/kg initially, and an extra dose of 1.5 ml/kg, if necessary

Eligibility

Sex/Gender

All

Age

No minimum to 7 Days

Inclusion criteria

Inclusion criteria: Inclusion criteria: (All of the following) premature infants weighing less than 1500 grams; have respiratory distress syndrome; require a surfactant; treated with CPAP and with FIo2> 40%. exclusion criteria:Infants weighing less than 1000 grams; more than 2 twin pregnancies; pregnancies with birth trauma; congenital anomalies; perinatal asphyxia; neonatal transfers from other institutions.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Duration of respiratory support required. Timepoint: The first two weeks after the intervention. Method of measurement: Recording of the time between the onset and the end of respiratory support.;Duration of additional oxygen requirement. Timepoint: The first two weeks after the intervention. Method of measurement: Recording of the time between the onset and the end of oxygen therapy.	—

Secondary

Measure	Time frame
Length of stay in hospital. Timepoint: one month. Method of measurement: The time between admission and the beginning of the intervention until the end of the intervention and discharge from the hospital.;The number of deaths. Timepoint: one month. Method of measurement: The number of cases of intervention or control that died during the study.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Meisam Reza Boghrati

Jondi Shapoor University of Medical Sciences, Ahvaz

research@ajums.ac.ir+98 61 3336 1948

Outcome results

None listed

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