About: Less invasive surfactant administration versus endotracheal surfactant instillation followed by limited peak pressure ventilation in preterm infants with respiratory distress syndrome in China: study protocol for a randomized controlled trial

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About: Less invasive surfactant administration versus endotracheal surfactant instillation followed by limited peak pressure ventilation in preterm infants with respiratory distress syndrome in China: study protocol for a randomized controlled trial Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
title	Less invasive surfactant administration versus endotracheal surfactant instillation followed by limited peak pressure ventilation in preterm infants with respiratory distress syndrome in China: study protocol for a randomized controlled trial
Creator	Jiang, Hong Shi, Jingyun Du, Lizhong Chen, Zhijun Mei, Hua Zhu, Jiajun Lv, Qin Bao, Yingying Dai, Yuxuan Huang, Huafei Jiang, Yejun Shi, Yongyan Sun, Xuemei Sun, Yanhui Yang, Chuangzhong
source	PMC
abstract	BACKGROUND: Less invasive surfactant administration (LISA) is a way of giving surfactant without endotracheal intubation and has shown to be promising in reducing the incidence of bronchopulmonary dysplasia (BPD) in preterm infants. However, the mechanism underlying its beneficial effect and variations in the technique of administration may prevent its widespread use. This trial aims to evaluate the effects of two methods of surfactant administration, LISA or endotracheal surfactant administration followed by low peak pressure (LPPSA) ventilation, in preterm infants with respiratory distress syndrome (RDS). METHODS: The LISA Or Low Peak Pressure trial is to be conducted in 14 tertiary neonatal intensive care units in China. A total of 600 preterm infants born with gestational age between 25(0/7) and 31(6/7) weeks and with a primary diagnosis of RDS will be involved in the study. Infants will be randomized to the LISA or LPPSA group when surfactant therapy is indicated. Primary outcomes include mortality, severity of bronchopulmonary dysplasia at 36 weeks of postmenstrual age (PMA), and mechanical ventilation (MV) in the first 72 h of life. Secondary outcomes include the days of MV, duration of all sorts of non-invasive respiratory support, fraction of inspired oxygen, oxygen saturation before and after surfactant administration, and time required to perform the procedure for surfactant administration. The incidence of comorbidities, including retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH), hemodynamically significant patent ductus arteriosus (hsPDA), pneumothorax, and massive pulmonary hemorrhage within 48 h of surfactant administration, and the failure rates of each technique will be determined. DISCUSSION: Data from recent systematic review and meta-analysis have suggested a possible improvement in outcomes of preterm infants with RDS by the LISA technique. However, robust evidence is lacking. Why LISA plays a potential role in reducing respiratory morbidity, mainly BPD in preterm infants, remains unclear. The possible explanations are the active and uninterrupted delivery of continuous positive airway pressure during the LISA procedure and the avoidance of complications caused by intubation and relatively high pressure/volume ventilation following surfactant administration. We hypothesized that LISA’s effectiveness lies mainly in avoiding relatively high-pressure positive ventilation immediately following surfactant administration. Thus, this multicenter randomized controlled trial will focus on issues of endotracheal intubation and the pressure/volume used during conventional surfactant administration. The effectiveness, safety and comorbidities of preterm infants following LISA or LPPSA will be evaluated. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR1900020970. Registered on 23 January 2019.
has issue date	2020-06-11(xsd:dateTime)
bibo:doi	10.1186/s13063-020-04390-3
bibo:pmid	32527290
has license	cc-by
sha1sum (hex)	6bf34197714ce4a34cf8ecb682013ef059e1fcc6
schema:url	https://doi.org/10.1186/s13063-020-04390-3
resource representing a document's title	Less invasive surfactant administration versus endotracheal surfactant instillation followed by limited peak pressure ventilation in preterm infants with respiratory distress syndrome in China: study protocol for a randomized controlled trial
has PubMed Central identifier	PMC7289227
has PubMed identifier	32527290
schema:publication	Trials
resource representing a document's body	covid:6bf34197714ce4a34cf8ecb682013ef059e1fcc6#body_text
is schema:about of	named entity 'evaluate' named entity 'administration' named entity 'RDS' named entity 'surfactant' named entity 'PEAK PRESSURE' named entity 'VARIATIONS' named entity 'IS A' named entity 'promising' named entity 'LISA' named entity 'surfactant' named entity 'surfactant' named entity 'surfactant' named entity 'Zhejiang University' named entity 'intubation' named entity 'maintenance dose' named entity 'multiple birth' named entity 'PEEP' named entity 'meta-analysis' named entity '28 days' named entity 'LISA' named entity 'SAEs' named entity 'surfactant' named entity 'morbidity' named entity 'SPSS' named entity 'morbidity' named entity 'bradycardia' named entity 'gestational weeks' named entity 'New Zealand' named entity 'infant dies' named entity 'fraction of inspired oxygen' named entity 'steroid' named entity 'LISA' named entity 'disability' named entity 'surfactant' named entity 'NICU' named entity 'Beijing' named entity 'surfactant' named entity 'respiratory support' named entity 'Adverse events' named entity 'stage IIIB' named entity 'surfactant' named entity 'oxygen' named entity 'PEEP' named entity 'IVH' named entity 'LISA' named entity 'LISA' named entity 'pulmonary compliance' named entity 'arterial blood gas' named entity 'case report form' named entity 'positive end-expiratory pressure' named entity 'RDS' named entity 'IVH' named entity 'preterm infants' named entity 'surfactant' named entity 'preterm infants' named entity 'hsPDA' named entity 'premedication' named entity 'surfactant' named entity 'surgical intervention' named entity 'respiratory support' named entity 'Preterm infant' named entity 'linear regression model' named entity 'surfactant' named entity 'oxygen' named entity 'metabolic acidosis' named entity 'LISA' named entity 'LISA'

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