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Administration of budesonide with surfactant and prevention of bronchopulmonary dysplasia

Effect of intratracheal budesonide with surfactant in management of respiratory distress syndrome for prevention of bronchopulmonary dysplasia in preterm infants

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100512003915N20
Enrollment
128
Registered
2018-07-07
Start date
2018-04-16
Completion date
Unknown
Last updated
2018-09-11

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: Intervention group: neonates receive budesonide 0.25 mg/kg in addition to intratracheal surfactant. Intervention 2: Control group: neonates receive intratracheal surfactant 2.5 cc/kg (

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 3 Days

Inclusion criteria

Inclusion criteria: gestation age 26-30 weeks birth weight less than 1250 grams respiratory distress syndrome

Exclusion criteria

Exclusion criteria: 5 minute Apgar score less than 4 congenital heart disease except patent ductus arteriosus and atrial septal defect necrotizing entrocololitis major congenital anomalies, esophageal atresia, diaphragmatic hernia chromosomal anomalies shock

Design outcomes

Primary

MeasureTime frame
Reintubation in first 3 days after extubation. Timepoint: We evaluate the neonate immediately after intervention and daily till 3 days after intervention and extubation. Method of measurement: tracheal reintubation.;Need to second doses of surfactant. Timepoint: Daily till day 3 of birth and 3 days after intervention. Method of measurement: surfactant administration.;Bronchopulmonary dysplasia. Timepoint: Daily till 28 days after birth and day 28 after intervention. Method of measurement: need to supplemental oxygen.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactManizheh Mostafa Gharehbaghi

Tabriz University of Medical Sciences

gharehbaghimm@yahoo.com+98 41 3553 9161

Outcome results

None listed

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