The effect of melatonin in the prevention of bronchopulmonary dysplasia in neonates admitted to Neonatal intensive care unit of Mahdieh Hospital

Phase 3

• Conditions: bronchopulmonary dysplasia.; Bronchopulmonary dysplasia originating in the perinatal period; P27.1

• Registration Number: IRCT20230526058294N1
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Premature neonates between 26 and 32 weeks with respiratory distress syndrome need surfactant injection

Exclusion Criteria

Apgar five minutes less than four
Evidence of necrotizing enterocolitis before surfactant administration
chromosomal disorders, esophageal atresia, diaphragmatic hernia
Evidence of congenital heart diseases other than Atrial Septal Defect and Patent ductus arteriosus
Major congenital anomaly of heart failure requiring treatment

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BRONCHOPULMONARY DYSPLASIA. Timepoint: Before initiation of the study, 28 and 56 days after birth. Method of measurement: Inspiratory oxygen fraction:The percentage of oxygen that is present in the air of the newborn, in order to investigate respiratory distress syndrome, the need for oxygen or respiratory assistance for more than 28 days after birth to investigate bronchopulmonary dysplasia.