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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230526058294N1
Enrollment
300
Registered
2023-08-19
Start date
2023-04-20
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

bronchopulmonary dysplasia. Bronchopulmonary dysplasia originating in the perinatal period

Interventions

Intervention 1: Intervention group: In the intervention group, in addition to surfactant, melatonin drops at a dose of 0.1 milligram per kilogram of the baby's weight will be administered as oral drop

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 3 Days

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactfatemeh serati

Shahid Beheshti University of Medical Sciences

f.serati128@gmail.com+98 21 5506 2628

Outcome results

None listed

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