SURFACEN ARDS. Pediatrics. Phase III

Evaluation of the efficacy and safety of SURFACEN in the treatment of Acute Respiratory Distress Syndrome in pediatric patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000163

Enrollment

Registered

2013-06-21

Start date

2010-11-23

Completion date

Unknown

Last updated

2026-08-10

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

Conditions

Respiratory distress syndrome in pediatric patients

Interventions

Study Group (Experimental): Conventional treatment (oxygenation and mechanical ventilation) + SURFACEN at 100 mg using the endotracheal tube every 8 hours for 3 days. Control Group (Standard treatment

Eligibility

Sex/Gender

All

Age

28 Days to 18 Years

Inclusion criteria

Inclusion criteria: 1. Presence of ARDS within 72 hours of diagnosis, 2. PEEP> 5 cm H2O. 3. Patients whose parents / guardians give their written consent to participate in the study. 4. Aged 28 days old and 18 years inclusive.

Exclusion criteria

Exclusion criteria: 1. Onco-hematological diseases. 2. Chronic heart disease (ventricular septal defect, atrial septal defect, patent ductus arteriosus, pulmonary stenosis, coarctation of the aorta, aortic stenosis, tetralogy of Fallot, transposition of great arteries, tricuspid atresia and truncus). 3. Hypersensitivity to the surface or other component of the formulation.

Design outcomes

Primary

Measure	Time frame
Condition (Alive, Dead). Measurement time: 28 days	—

Secondary

Measure	Time frame
Gasometrical Evaluation (PaO2, PaCO2, pH, PaO2/FiO2, saturometry): Measuring time: before enrollment, 1h and 8h after each administration. In the control group these time are simulated. Ventilatory Evaluation (type of ventilation, V / minute, inspiratory tidal volume, expiratory tidal volume, respiratory rate, I/E, Pr Pico, Paw, FiO2 (default), PEEP, Static lung compliance and oxygenation index): Measuring time: before enrollment, 1h and 8h after each administration. In the control group these time are simulated. Clinical Evaluation (blood pressure (BP), heart rate (HR) and verify if the patient has symptoms of cyanosis (distal or generalized)): Measuring time: before enrollment, 1h and 8h after each administration. In the control group these time are simulated. Radiographic Evaluation (It is measured Chest radiography. They collect the presence or absence of inflammatory infiltrates in the lung fields, and compared with respect to the first assessment, establishing the following scale: Improvement: Decrease or disappearance of pulmonary infiltrates. Stability: Maintenance of pulmonary infiltrates despite treatment. Worsening: Progression with increased pulmonary infiltrates). Measuring time: before the first administration, daily for 3 days of treatment and the fifth day after administration In the control group these time are simulated. Days of stay in the ICU (days between the date of admissions and discharge of the Intensive Care Unit). Measuring time: at the discharge of the ICU. Days of mechanical ventilation (days between the date begins to mechanically ventilated and respiratory support is withdrawn). Measuring time: When the respiratory support is withdrawn Days of endotracheal intubation (days, between the date of the patient is intubated, and the date of the extubation). Measuring time: at the extubation. Complication (description of the complications related to the ARDS and their cause). Measuring time: before enrollment, 1h and 8h after each administrat	—

Measure

Time frame

Gasometrical Evaluation (PaO2, PaCO2, pH, PaO2/FiO2, saturometry): Measuring time: before enrollment, 1h and 8h after each administration. In the control group these time are simulated. Ventilatory Evaluation (type of ventilation, V / minute, inspiratory tidal volume, expiratory tidal volume, respiratory rate, I/E, Pr Pico, Paw, FiO2 (default), PEEP, Static lung compliance and oxygenation index): Measuring time: before enrollment, 1h and 8h after each administration. In the control group these time are simulated. Clinical Evaluation (blood pressure (BP), heart rate (HR) and verify if the patient has symptoms of cyanosis (distal or generalized)): Measuring time: before enrollment, 1h and 8h after each administration. In the control group these time are simulated. Radiographic Evaluation (It is measured Chest radiography. They collect the presence or absence of inflammatory infiltrates in the lung fields, and compared with respect to the first assessment, establishing the following scale: Improvement: Decrease or disappearance of pulmonary infiltrates. Stability: Maintenance of pulmonary infiltrates despite treatment. Worsening: Progression with increased pulmonary infiltrates). Measuring time: before the first administration, daily for 3 days of treatment and the fifth day after administration In the control group these time are simulated. Days of stay in the ICU (days between the date of admissions and discharge of the Intensive Care Unit). Measuring time: at the discharge of the ICU. Days of mechanical ventilation (days between the date begins to mechanically ventilated and respiratory support is withdrawn). Measuring time: When the respiratory support is withdrawn Days of endotracheal intubation (days, between the date of the patient is intubated, and the date of the extubation). Measuring time: at the extubation. Complication (description of the complications related to the ARDS and their cause). Measuring time: before enrollment, 1h and 8h after each administrat

—

Countries

Cuba

Contacts

Public ContactYinet Barrese Perez

National Coordinating Center for Clinical Trials (CENCEC)

yinet@cencec.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026