Evaluation of Melatonin Efficacy in Treatment of Respiratory Distress Syndrome and Prevention of Bronchopulmonary Dysplasia

Phase 3

Conditions: Condition 1: respiratory distres syndrom. Condition 2: Bronchopolmonary displasia.
Respiratory distress of newborn, unspecified
Bronchopulmonary dysplasia originating in the perinatal period
P22.9
P27.1

Registration Number: IRCT20190518043629N1

Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 80

Inclusion Criteria

Premature Neonates between 26 and 32 weeks of age born at Al-Zahra Hospital
Respiratory distress syndrome requires injection of surfactant

Exclusion Criteria

Less than four minutes Apgar , fewer than four
Evidence of congenital heart disease other than ASD and PDA
Evidence of necrotizing antralocytosis before the administration of surfactant
Congenital major anomalies, heart failure requiring treatment
Shock
Clear chromosomal abnormalities
Esophageal atresia
Diaphragmatic hernia

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bronchopulmonary dysplasia. Timepoint: Requires more than 21% oxygen for at least 28 days. Method of measurement: Fractional oxygen (Fio2) read by blender or ventilator and recorded in the file.

Secondary Outcome Measures

Name	Time	Method
Respiratory distress syndrome: Symptoms of respiratory distress due to surfactant deficiency mainly caused in preterm infants. Timepoint: One hour and four hours after treatment and the number of times the surfactant is needed. Method of measurement: Existence of respiratory distress requiring intubation or establishment of NCPAP with at least 5 cm water pressure at first hour of birth with Fractional oxygen (Fio2) requires respiratory fraction greater than 40% at 26 weeks gestation and respiratory fraction greater than 30% at 26 weeks gestation. Or continued respiratory distress, despite the onset of NCPAP, which is diagnosed by a neonatal or pediatric specialist or pediatric resident.