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Evaluation effect of Beracsurf and Curosurf in treatment of Respiratory Distress Syndrome in preterm infants.

Companion of Effectivenessof Beractant (Beracsurf) versus Poractant Alfa (Curosurf ) in the Treatment of Respiratory Distress Syndrome(RDS) in Preterm Infant.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180404039187N4
Enrollment
200
Registered
2019-09-01
Start date
2019-07-11
Completion date
Unknown
Last updated
2019-10-07

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

Conditions

Respiratory Distress Syndrome. X Diseases of the respiratory system

Interventions

Intervention 1: Intervention group: Group receiving Beracsurf : this group will receive Beracsurf at a dose of 4 ml/kg every six hours and maximum 4 dose. Variation of Fio2 in first and every six hour

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 224 Days

Inclusion criteria

Inclusion criteria: Birth weight 750_1750 gr Preterm that born less than 32 weeks Definitive diagnosis RDS based on clinical signs or radiographic evidence Fio2 =0.3 to keep saturated oxygen 96_98%

Exclusion criteria

Exclusion criteria: Respiratory failure because of non RDS Lung hypoplasia Apgar 4= in five minutes birth Treatment with other exogenous surfactant Untreated pneumothorax Hypotension Hypoglycemia Using high frequence ventilation before prescription of first dose of surfactant Intra ventricular hemorrhage

Design outcomes

Primary

MeasureTime frame
Variation of Fio2. Timepoint: At the beginning and every six hours after starting the study. Method of measurement: Measure the rate of Fio2 and saturated oxygen.;The frequency of getting surfactants. Timepoint: During the study. Method of measurement: Measure the frequency of injections.;Number of days needed intubation and mechanical ventilation. Timepoint: During the study. Method of measurement: Counting days under mechanical ventilation.;Number of hospital days. Timepoint: During the study. Method of measurement: Count the days of hospitalization.;Getting of antanatal steroide. Timepoint: During the study. Method of measurement: Checking patient records.;Need for reinventing. Timepoint: During the study. Method of measurement: Checking patient records.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactTabriz University of Medical Sciences

Tabriz University of Medical Sciences

Elnaz_shaseb_64@yahoo.com+98 144933344198

Outcome results

None listed

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