Effect of Budesonide with Surfactant on the prevention of chronic lung disease in premature infants

Effect of Budesonide plus Surfactant in prevention of chronic lung disease in premature infants with gestational age less than 30 weeks

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20171030037093N38

Enrollment

190

Registered

2020-05-08

Start date

2020-04-20

Completion date

Unknown

Last updated

2020-05-18

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

Conditions

Chronic lung disease. Other chronic respiratory diseases originating in the perinatal period

Interventions

Intervention 1: Intervention group: Babies in need of surfactant receive exogenous surfactant + budesonide solution 0.25 mg / kg or 0.5 cc / kg which is injected into the face via an intratracheal cat

Eligibility

Sex/Gender

All

Age

No minimum to 7 Months

Inclusion criteria

Inclusion criteria: Premature infants with pre-existing GA <30 weeks admitted to the NICU Receives some kind of non-invasive respiratory support including CPAP and physician decides to prescribe surfactant

Exclusion criteria

Exclusion criteria: Major congenital anomalies affecting neonatal respiration (severe pulmonary hypoplasia, congenital lung abnormality, congenital airway obstruction) Asphyxia Gastrointestinal anomalies that cause the baby to be transferred to another center Sepsis before starting the study Cyanotic heart disease

Design outcomes

Primary

Measure	Time frame
The time required for mechanical ventilation. Timepoint: 4 to 6 weeks after birth. Method of measurement: Check list.;The period of time of no need for non-invasive ventilation. Timepoint: 4 to 6 weeks after birth. Method of measurement: Check list.;Duration of hospital stay. Timepoint: 4 to 6 weeks after birth. Method of measurement: Check list.;The period of time of surfactant injections. Timepoint: 4 to 6 weeks after birth. Method of measurement: Check list.;The condition of chronic lung disease. Timepoint: 4 to 6 weeks after birth. Method of measurement: Check list.	—

Measure

Time frame

The time required for mechanical ventilation. Timepoint: 4 to 6 weeks after birth. Method of measurement: Check list.;The period of time of no need for non-invasive ventilation. Timepoint: 4 to 6 weeks after birth. Method of measurement: Check list.;Duration of hospital stay. Timepoint: 4 to 6 weeks after birth. Method of measurement: Check list.;The period of time of surfactant injections. Timepoint: 4 to 6 weeks after birth. Method of measurement: Check list.;The condition of chronic lung disease. Timepoint: 4 to 6 weeks after birth. Method of measurement: Check list.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir-Mohammad Armanian

Esfahan University of Medical Sciences

armanian@med.mui.ac.ir0098 31 6255555

Outcome results

None listed

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