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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190518043629N1

Enrollment

Registered

2020-04-07

Start date

2019-08-24

Completion date

Unknown

Last updated

2020-05-18

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

Conditions

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

Interventions

Intervention 1: Control group: In this group, the surfactant is injected into the trachea. How to inject Surfactant by Insure, the patient will be intubated and post-injection will be extubated and su

Eligibility

Sex/Gender

All

Age

1 Days to 3 Days

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMajid Fekri

Tabriz University of Medical Sciences

majid.fekri1362@gmail.com+98 41 3556 9543

Outcome results

None listed

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