camparison of the effects of surfactant with and without budesonide on the outcomes of neonatal respiratory distress syndrome

comparison of the effects of surfactant with and without budesonide on the outcomes of respiratory distress syndrome in infants with a gestational age less than 32 weeks

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211218053444N3

Enrollment

Registered

2024-04-06

Start date

2023-12-31

Completion date

Unknown

Last updated

2024-05-27

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 syndrome of newborn

Interventions

Intervention 1: Intervention group: Premature infants hospitalized with a gestational age less than 32 weeks with neonatal respiratory distress syndrome that severity of their respiratory distress was

Eligibility

Sex/Gender

All

Age

1 Days to 3 Days

Inclusion criteria

Inclusion criteria: neonates with respiratory distress syndrome with a gestational age of less than 32 weeks

Exclusion criteria

Exclusion criteria: severe asphyxia Severe congenital anomalies shock Cardiovascular instability Lack of parental consent Maternal chorioamnionitis

Design outcomes

Primary

Measure	Time frame
The severity of respiratory distress at birth, which requires surfactant injection based on the respiratory score of newborns. Timepoint: 1?2?3?4?5?6?7?8?9?10 day. Method of measurement: Infants respiratory score.	—

Secondary

Measure	Time frame
Necrotizing enterocolitis:infants who suffer from intestinal wall edema and feeding intolerance. Timepoint: 1?2?3?4?5?6?7?8?9?10 days. Method of measurement: view.;Intraventricular hemorrhage. Timepoint: 1?2?3?4?5?6?7?8?9?10 days. Method of measurement: Brain ultrasound.;Pneumothorax. Timepoint: 1?2?3?4?5?6?7?8?9?10 days. Method of measurement: lung radiography.;Duration of mechanical ventilation. Timepoint: 1?2?3?4?5?6?7?8?9?10 days. Method of measurement: view.;Sepsis. Timepoint: 1?2?3?4?5?6?7?8?9?10 days. Method of measurement: blood culture.	—

Measure

Time frame

Necrotizing enterocolitis:infants who suffer from intestinal wall edema and feeding intolerance. Timepoint: 1?2?3?4?5?6?7?8?9?10 days. Method of measurement: view.;Intraventricular hemorrhage. Timepoint: 1?2?3?4?5?6?7?8?9?10 days. Method of measurement: Brain ultrasound.;Pneumothorax. Timepoint: 1?2?3?4?5?6?7?8?9?10 days. Method of measurement: lung radiography.;Duration of mechanical ventilation. Timepoint: 1?2?3?4?5?6?7?8?9?10 days. Method of measurement: view.;Sepsis. Timepoint: 1?2?3?4?5?6?7?8?9?10 days. Method of measurement: blood culture.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLeila Sharifi

Kerman University of Medical Sciences

dinaleyla695@gmail.com+98 34 3132 8000

Outcome results

None listed

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