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SURFACEN® in phase IV of clinical trial in pediatrics in Holguín
  • Written by Maylín Betancourt Verdecia
Sonia González Alvides, Coordinator of Clinical Trials of the Pediatric Holguin, shows the first bottles of SURFACEN® arrived at the hospital to begin the phase IV of the clinical trial of the product. Photo: Maylín Betancourt Verdecia
On February 21, the first 18 bottles of SURFACEN®, an exogenous pulmonary medication, were deposited in the Octavio de la Concepción and Pedraja Children's Hospital in Holguin, aimed at the treatment of Acute Respiratory Syndrome in pediatric patients admitted to Intensive Care, an action that started to phase IV of the clinical trial of the product.

According to the Coordinator of Clinical Trials in the hospital institution, the graduated in nursing, Sonia González Alvides: "This medicine has been used previously in Neonatology with very good results. It will be applied to patients ventilated at pediatric ages (from newborn to 15 years old), for having properties to help the oxygenation of the lungs. Everything is ready to start since the complete treatment for a patient is found deposited in our pharmacy. "

In order to be treated with this clinical trial, patients are required to be admitted to Intensive Care with endotracheal intubation and mechanical ventilation and must not have passed seven days after the onset of the symptoms of Acute Respiratory Syndrome.

The annual plan comprises eight patients. Each beneficiary will go through a treatment with duration of three days, whose maximum dose will be 18 bulbs.

"100 milligrams will be used endotrachially, through a probe every eight hours, with a maximum duration of three days and no more than nine doses should be administered," added the Coordinator of Clinical Trials of the pediatric.

This medicine obtained from the bronchoalveolar lavage of lungs of pigs in a process of purification of the active ingredients, results in enrichment in the fraction of anionic phospholipids.

As a result of the application of SURFACEN®, a rapid increase in oxygenation must occur, that´s why clinical observation and monitoring of oxygenation in the patient is important.

It exerts its pharmacological effect through local action exclusively at the pulmonary level.

It is stored refrigerated (2 to 8º C), but before reconstitution it must be placed at room temperature, at least 10 minutes. As it is sterile and does not contain preservatives, its handling must be carried out under aseptic conditions and, once reconstituted; it should be used as soon as possible.

A clinical trial requires very specific measures and a detailed work carried out by specialized personnel, "As part of the documentation of the procedure an informed consent of the relative is needed, each patient has his / her clinical history, his / her data collection notebook, where the eventualities that could happen after the first dose of the medication is applied to the patient are registered in case any adverse reaction is experienced, "González said.

So this clinical trial enters its phase IV, which has been preceded by many years of work and efforts of a countless group of specialists, scientists and medical and nursing staff who with the application of this protocol want to contribute from their knowledge and modest efforts to the development of Cuban Medicine.

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