Respiratory Distress Syndrome. Respiratory distress syndrome of newborn
Conditions
Interventions
Intervention 1: Intervention group: A 3 ml vial of Varasurf with a concentration of 80mg/ml (pulmonary surfactant manufactured by Artiman Pharmed Alborz), which is administered intratracheally (throug
Sponsors
Artiman Pharmed Alborz
Eligibility
Sex/Gender
All
Age
1 Days to 1 Days
Inclusion criteria
Inclusion criteria: Premature neonate with respiratory distress syndrome based on physician's diagnosis Born with gestational age of 28 to 34 weeks in the location of study site With birth weight between 1000 and 2500 grams Study enrollment and receiving the first dose of surfactant up to 6 hours after birth The need for fraction of inspired oxygen (FIO2) more than 30% to maintain saturation of peripheral oxygen (SPO2) 90-94% Failure of early nasal continuous positive airway pressure (CPAP) immediately after birth Signing the informed consent form by the parent or legal guardian of the neonate
Exclusion criteria
Exclusion criteria: Moderate to severe asphyxia at birth (Apgar Score 5- and 10-minute, less than 5 or the need for continuous resuscitation 10 minutes after the birth of the neonate, or umbilical cord arterial blood gas (ABG) result with pH less than 7) Neonatal encephalopathy Receiving any type of surfactant by neonates before the study enrollment Diagnosis of major congenital anomalies (congenital cardiac anomalies, life-threatening anomalies, respiratory failure due to causes other than RDS, and chromosomal abnormalities) Presence of pulmonary hemorrhage and pneumothorax before the study enrollment Simultaneous participation of the neonate in other clinical trials The neonate's need for surgical procedures The need for invasive mechanical ventilation of the neonates before study enrollment or before administration of surfactant (phase I only) Neonatal hypoglycemia (plasma glucose concentration lower than 50 mg/dl with a glucometer) History of mother's addiction to alcohol or drugs Diagnosis of maternal chorioamnionitis History of neonatal convulsions Presence of meconium aspiration in neonate Rupture of membrane more than 18 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The area under the curve of the need for fraction of inspired oxygen. Timepoint: Immediately before the administration of surfactant until 6 hours (0, 0.25, 0.5, 1, 2, 3, 4, 5 and 6 hours) after the administration of the first surfactant. Method of measurement: Fraction of inspired oxygen recording.;Duration of respiratory support need (invasive and non-invasive mechanical ventilation). Timepoint: Up to 28 days after receiving the first dose of surfactant. Method of measurement: Day. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in need to fraction of inspired oxygen. Timepoint: Immediately before surfactant injection and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 18, 24, 36, 48 and 72 hours and 4, 5, 6 and 7 days after administration of the first dose of surfactant. Method of measurement: fraction of inspired oxygen recording.;Need for continued the invasive mechanical ventilation. Timepoint: Up to 72 hours after surfactant administration. Method of measurement: Neonates rate.;The saturation of peripheral oxygen percentage (SpO2). Timepoint: Immediately before surfactant injection and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 18, 24, 36, 48 and 72 hours and 4, 5, 6 and 7 days after administration of the first dose of surfactant. Method of measurement: Pulse oximetry.;Mean Airway Pressure. Timepoint: Immediately before surfactant injection and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 18, 24, 36, 48 and 72 hours and 4, 5, 6 and 7 days after administration of the first dose of surfactant. Method of measurement: respiratory ventilation system recording.;Duration of hospitalization. Timepoint: Up to 28 days after birth or 36 weeks post mensural age. Method of measurement: Day.;Frequency of surfactant administration. Timepoint: Up to 28 days after birth or 36 weeks post mensural age. Method of measurement: Recording the frequency of administration.;Patent ductus arteriosus (PDA) occurrence. Timepoint: Up to 28 days after birth or 36 weeks post mensural age. Method of measurement: number/percentage.;Pneumothorax occurrence. Timepoint: Up to 28 days after birth or 36 weeks post mensural age. Method of measurement: number/percentage (diagnosis based on chest-X Ray).;Sepsis occurrence. Timepoint: Up to 28 days after birth or 36 weeks post mensural age. Method of measurement: number/percentage (diagnosis by positive blood culture in neonates with suspected clinical symptoms).;Intra ventricular hemorrhage (IVH) occurrence. Timepoint: Up to 28 days after birth or 36 weeks post mensural age. Method of measurement: number/ | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFatemeh Sadat Emami
Tiva Pharmed Salamat
Outcome results
None listed