The effect of intratracheal surfactant with budesonide in the treatment of respiratory distress syndrome

Comparison of administration of intratracheal surfactant with and without budesonide in the treatment of respiratory distress syndrome in preterm infants

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240524061883N1

Enrollment

Registered

2024-10-03

Start date

2024-10-06

Completion date

Unknown

Last updated

2025-01-08

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: BLES surfactant (manufactured by BLES Biochemical Company, in Canada), with a dose of 5 cc/kg, followed by budesonide with the brand name Palmicort (Astrazenka, Swe

Eligibility

Sex/Gender

All

Age

1 Days to No maximum

Inclusion criteria

Inclusion criteria: Preterm infants with a gestational age of 28 to 34 weeks birth weight of 700 to 2000 gr infants with respiratory distress syndrome respiratory ACORN score (Acute Care of at Risk Neonate) up to 5 Persistence of respiratory distress and grunting despite the use of nasal positive pressure ventilation (NCPAP) with PEEP=5-6 in the first 2 hours after birth FIO2 greater than 40% despite use of NCPAP without evidence of hypoxic ischemic encephalopathy, no major anomalies or chromosomal disorders, and no other causes of respiratory distress such as diaphragmatic hernia and congenital heart disease.

Exclusion criteria

Exclusion criteria: Heart failure that needs treatment shock Evidence of persistent fetal circulation (PFC) TORCH infection

Design outcomes

Primary

Measure	Time frame
Oxygen requirement (fractional inspiratory oxygen) in 6 hours after surfactant administration. Timepoint: 6 hours after surfactant administration. Method of measurement: Air and oxygen blender.;Level of respiratory support. Timepoint: At admission, 2 hours after birth, after surfactant administration, 6 hours after surfactant administration, 72 hours after birth, 14 days, 28 days. Method of measurement: visual.	—

Measure

Time frame

Oxygen requirement (fractional inspiratory oxygen) in 6 hours after surfactant administration. Timepoint: 6 hours after surfactant administration. Method of measurement: Air and oxygen blender.;Level of respiratory support. Timepoint: At admission, 2 hours after birth, after surfactant administration, 6 hours after surfactant administration, 72 hours after birth, 14 days, 28 days. Method of measurement: visual.

—

Secondary

Measure	Time frame
Death. Timepoint: Whenever it happened. Method of measurement: Visual.;Complications of prematurity and respiratory distress syndrome (air leak syndrome, pulmonary bleeding, necrotizing enterocolitis, intraventricular hemorrhage, retinopathy of prematurity). Timepoint: Any time it happened and ophthalmoscope examination at the age of 28 days. Method of measurement: Physical examination and clinical evaluation.	—

Measure

Time frame

Death. Timepoint: Whenever it happened. Method of measurement: Visual.;Complications of prematurity and respiratory distress syndrome (air leak syndrome, pulmonary bleeding, necrotizing enterocolitis, intraventricular hemorrhage, retinopathy of prematurity). Timepoint: Any time it happened and ophthalmoscope examination at the age of 28 days. Method of measurement: Physical examination and clinical evaluation.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohsen Haqshenas

Babol University of Medical Sciences

Matia.mojaveri@yahoo.com+98 11 3219592

Outcome results

None listed

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