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A multicenter, randomized, double-blind trial of a new porcine surfactant in premature infants with respiratory distress syndrome.

ABSTRACT: To compare the efficacy and safety of a new porcine-derived pulmonary surfactant developed by Instituto Butantan with those of animal-derived surfactants commercially available in Brazil, regarding neonatal mortality and the major complications of prematurity in preterm newborns with birth weight up to 1500g and diagnosed with respiratory distress syndrome.Neonates diagnosed with respiratory distress syndrome were randomized to receive either Butantan surfactant (Butantan group) or one of the following surfactants: Survanta® or Curosurf®. Newborns receiving Survanta® or Curosurf® comprised the control group. The main outcome measures were mortality rates at 72 hours and at 28 days of life; the typical complications of prematurity as evaluated on the 28th day of life were defined as secundary outcomes.No differences were observed between the Butantan (n=154) and control (n=173) groups in relation to birth weight, gestational age, sex, and prenatal use of corticosteroids, or in mortality rates both at 72 hours (14.19% versus 14.12%; p=0.98) and at 28 days (39.86% versus 33.33%; p=0.24) of life. Higher 1- and 5-minute Apgar scores were observed among control group newborns. No differences were observed as regards the secondary outcomes, except for greater need for supplemental oxygen and a higher incidence of interstitial pulmonary emphysema in the Butantan group.The mortality rates at 72 hours and 28 days of life and the incidence of major complications of prematurity were comparable to those found with the animal-derived surfactants commercially available in Brazil, showing the efficacy and safety of the new surfactant in the treatment of respiratory distress syndrome in newborns.

SUBMITTER: Rebello CM

PROVIDER: S-EPMC4879903 | biostudies-literature | 2014 Oct-Dec

REPOSITORIES: biostudies-literature

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A multicenter, randomized, double-blind trial of a new porcine surfactant in premature infants with respiratory distress syndrome.

Rebello Celso Moura CM Precioso Alexander Roberto AR Mascaretti Renata Suman RS

Einstein (Sao Paulo, Brazil) 20141001 4

<h4>Objective</h4>To compare the efficacy and safety of a new porcine-derived pulmonary surfactant developed by Instituto Butantan with those of animal-derived surfactants commercially available in Brazil, regarding neonatal mortality and the major complications of prematurity in preterm newborns with birth weight up to 1500g and diagnosed with respiratory distress syndrome.<h4>Methods</h4>Neonates diagnosed with respiratory distress syndrome were randomized to receive either Butantan surfactant ...[more]

PMID: 25628188

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Project description:ObjectivesEffective treatment options for surfactant therapy in acute respiratory distress syndrome and coronavirus disease 2019 have not been established. To conduct preclinical studies in vitro and in vivo to evaluate efficiency, particle size, dosing, safety, and efficacy of inhaled surfactant using a breath-synchronized, nebulized delivery system in an established acute respiratory distress syndrome model.DesignPreclinical study.SettingResearch laboratory.SubjectsAnesthetized pigs.InterventionIn vitro analysis included particle size distribution and inhaled dose during simulated ventilation using a novel breath-synchronized nebulizer. Physiologic effects of inhaled aerosolized surfactant (treatment) were compared with aerosolized normal saline (control) in an adult porcine model (weight of 34.3 ± 0.6 kg) of severe acute respiratory distress syndrome (Pao2/Fio2 <100) with lung lavages and ventilator-induced lung injury during invasive ventilation.Measurements and main resultsMass median aerosol diameter was 2.8 µm. In vitro dose delivered distal to the endotracheal tube during mechanical ventilation was 85% ± 5%. Nebulizers were functional up to 20 doses of 108 mg of surfactant. Surfactant-treated animals (n = 4) exhibited rapid improvement in oxygenation with nearly full recovery of Pao2/Fio2 (~300) and end-expiratory lung volumes with nominal dose less than 30 mg/kg of surfactant, whereas control subjects (n = 3) maintained Pao2/Fio2 less than 100 over 4.5 hours with reduced end-expiratory lung volume. There was notably greater surfactant phospholipid content and lower indicators of lung inflammation and pathologic lung injury in surfactant-treated pigs than controls. There were no peridosing complications associated with nebulized surfactant, but surfactant-treated animals had progressively higher airway resistance post treatment than controls with no differences in ventilation effects between the two groups.ConclusionsBreath-synchronized, nebulized bovine surfactant appears to be a safe and feasible treatment option for use in coronavirus disease 2019 and other severe forms of acute respiratory distress syndrome.

Project description:Background/Aims: Nasal continuous positive airway pressure (nCPAP) was recommended as the initial respiratory support for spontaneous breathing in infants with very low birth weight and neonatal respiratory distress syndrome (NRDS). Less invasive surfactant administration (LISA) and minimally invasive surfactant therapy (MIST) have been reported to reduce the incidence of bronchopulmonary dysplasia (BPD). This study aimed to explore the applicability of minimally invasive surfactant administration (MISA) in China. Materials and Methods: MISA was a randomized controlled study conducted at eight level III neonatal intensive care units (NICUs) in China. Spontaneously breathing infants born at 25+0 to 31+6 weeks' gestation who progressively developed respiratory distress during the first 6 h after birth were randomly assigned to receive MISA or endotracheal intubation surfactant administration (EISA). The primary outcome was the difference in the morbidity of BPD between two groups of infants with MISA and EISA at 36 weeks corrected gestational age. Results: Demographic and clinical characteristics of the 151 infants in the MISA group were similar to the 147 infants in the EISA group. The comparison showed no clear benefits in the MISA group in the incidence of BPD, while infants from the EISA group had higher rates of patent ductus arteriosus (PDA) (60.5 vs. 41.1%, p = 0.001). The duration of surfactant infusion and the total time of surfactant administration in the MISA group were significantly longer than in the EISA group. A slightly increased heart rate was noted 1 h post surfactant administration in the EISA group. In subgroup analysis, the comparison of 51 smaller (<30 weeks) preterm infants, named MISAs (n = 31) and EISAs (n = 20), showed a significant reduction of BPD (29.0 vs. 70.0%, p = 0.004) and PDA (29.0 vs. 65.0%, p = 0.011). In the subgroup analysis of blood gas, arterial oxygen saturation (SaO2) value at 1 and 12 h and partial pressure of arterial oxygen (PaO2) at 12 h were all higher in the EISA group compared to the MISA group. Conclusion: MISA had no clear benefit on the incidence of BPD, but it was related to a reduction in PDA. It is an appropriate therapy for spontaneous breathing in infants with extremely low birth weight and NRDS.

Dataset Information

A multicenter, randomized, double-blind trial of a new porcine surfactant in premature infants with respiratory distress syndrome.

Publications

A multicenter, randomized, double-blind trial of a new porcine surfactant in premature infants with respiratory distress syndrome.

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