Compare two kinds of Surfactant

Comparison of the Efficacy and Side-effects of Two Surfactants (Beraksurf, and Bles) in the Treatment of Respiratory Distress Syndrome among Preterm infants

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210501051148N1

Enrollment

128

Registered

2021-07-11

Start date

2021-05-31

Completion date

Unknown

Last updated

2021-08-30

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

Conditions

Respiratory distress syndrom. Respiratory distress syndrome of newborn

Interventions

Intervention 1: Intervention group 1: Intratecal administration of Surfactant kind Bles, Immediately after birth, up to 72 hours later, by clinical examination or by X-ray with the diagnosis of acute

Eligibility

Sex/Gender

All

Age

1 Days to 3 Days

Inclusion criteria

Inclusion criteria: Preterm neonate Respiratory distress syndrome

Exclusion criteria

Exclusion criteria: Congenital cardiac anomaly Congenital gastrointestinal anomaly Congenital urological anomaly Chromosomal disorder

Design outcomes

Primary

Measure	Time frame
Improvement Respiratory distress syndrom. Timepoint: ?From beginning, Daily. Method of measurement: Physical examination.;Mortality. Timepoint: From birthing continuous to end of treatment. Method of measurement: Vital sign checking.;Patent dactus arteriosus. Timepoint: From birthing intermittent echo cardiography. Method of measurement: Echo cardiography.;Intra ventricular hemorrhage. Timepoint: From birthing intermittent brain sonography. Method of measurement: Brain sonography.;Pulmonary hemorrhage. Timepoint: Daily. Method of measurement: Physical examination.;Pneumothorax. Timepoint: Daily. Method of measurement: Physical examination and chest x-ray.;Sepsis. Timepoint: From birthing intermittent. Method of measurement: Blood culture.	—

Measure

Time frame

Improvement Respiratory distress syndrom. Timepoint: ?From beginning, Daily. Method of measurement: Physical examination.;Mortality. Timepoint: From birthing continuous to end of treatment. Method of measurement: Vital sign checking.;Patent dactus arteriosus. Timepoint: From birthing intermittent echo cardiography. Method of measurement: Echo cardiography.;Intra ventricular hemorrhage. Timepoint: From birthing intermittent brain sonography. Method of measurement: Brain sonography.;Pulmonary hemorrhage. Timepoint: Daily. Method of measurement: Physical examination.;Pneumothorax. Timepoint: Daily. Method of measurement: Physical examination and chest x-ray.;Sepsis. Timepoint: From birthing intermittent. Method of measurement: Blood culture.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahdie Eslamian

Kerman University of Medical Sciences

m.eslamian84@gmail.com+98 34 3132 8000

Outcome results

None listed

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