Cuban Exogenous Pulmonary Surfactant in Treatment of Pediatric Acute Respiratory Distress Syndrome.
INTRODUCTION Acute respiratory distress syndrome is a complex heterogeneous disorder with low incidence but high case fatality in children. Treatment with pulmonary surfactants is a possible option. Surfacen, a Cuban exogenous pulmonary surfactant, has been proven safe and effective in premature new...
| Publicado en: | MEDICC Review Vol. 19; no. 2/3; pp. 24 - 32 |
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| Autores principales: | , , , , , , |
| Formato: | research tables/charts randomized controlled trial Journal Article |
| Publicado: |
Medical Education Cooperation with Cuba
Apr-Jul2017
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=124402242&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 124402242 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 15273172 903V jtl: MEDICC Review issn: 15273172 maglogo: N pubinfo: dt: Apr-Jul2017 vid: 19 iid: 2/3 pid: 54282 pub: Medical Education Cooperation with Cuba place: Oakland, California artinfo: ui: 124402242 124402242 124402242 10.37757/mr2017.v19.n2-3.5 124402242 ppf: 24 ppct: 8 formats: fmt: @attributes: type: P tig: atl: Cuban Exogenous Pulmonary Surfactant in Treatment of Pediatric Acute Respiratory Distress Syndrome. aug: au: Rodríguez-Moya, Valentín S. del Carmen Machado-Lubián, María Barrese-Pérez, Yinet Ávila-Albuerne, Yisel Uranga-Piña, Rolando Blanco-Hidalgo, Odalys Díaz-Casañas, Elaine affil: Staff pediatrician at Staff pediatrician at Martín Chang Puga General Teaching Hospital in Camagüey Province, Cuba sug: subj: Pulmonary Surfactants Therapeutic Use Respiratory Distress Syndrome, Acute Drug Therapy Human Randomized Controlled Trials Random Assignment Cuba Multicenter Studies Male Female Infant Child, Preschool Child Adolescence Pulmonary Surfactants Administration and Dosage Administration, Intratracheal Oxygen Saturation Intensive Care Units, Pediatric Respiration, Artificial Chi Square Test Fisher's Exact Test Survival Treatment Outcomes Infant: 1-23 months Child, Preschool: 2-5 years Child: 6-12 years Adolescent: 13-18 years Male Female ab: INTRODUCTION Acute respiratory distress syndrome is a complex heterogeneous disorder with low incidence but high case fatality in children. Treatment with pulmonary surfactants is a possible option. Surfacen, a Cuban exogenous pulmonary surfactant, has been proven safe and effective in premature newborns with hyaline membrane disease, but evidence regarding its efficacy in older children is still inconclusive. OBJECTIVE Determine Surfacen’s efficacy in improving oxygenation and increasing survival in children with acute respiratory distress syndrome. METHODS A multicenter (five pediatric intensive care units in four provinces), open-label, controlled, randomized phase III clinical trial with two treatment groups was conducted from November 2009 through August 2013, with 19 girls and 23 boys aged 1 month to 18 years. The experimental group (20 patients) received conventional treatment (oxygenation and mechanical ventilation) plus intratracheal instillation of Surfacen (100 mg/4 mL) every eight hours for three days. The control group (22 patients) received only conventional treatment. The primary dependent outcome was patient vital status (alive or deceased) 28 days after study enrollment. Other variables and outcomes analyzed were age, sex, ARDS presentation, Kirby index (arterial oxygen tension over inspired oxygen fraction), oxygenation index, static lung compliance, transcutaneous oxygen saturation, radiographic course, mechanical ventilation time and length of stay in neonatal intensive care. Statistical tests used were the chi-square test and Fisher exact test. RESULTS On day 28, there was 80% survival in the experimental group versus 38.1% in the control group. There were significant differences between the experimental and the control group in Kirby index, oxygenation index, static lung compliance and radiographic course, all favoring the experimental group. For every 2.38 patients treated in total, there was one additional survivor in the experimental group. CONCLUSIONS When combined with conventional therapy in the regimen employed, Surfacen improves oxygenation and increases survival in children with ARDS. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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