Universität zu Köln

Kribs, Angela, Roll, Claudia, Goepel, Wolfgang, Wieg, Christian, Groneck, Peter, Laux, Reinhard, Teig, Norbert, Hoehn, Thomas, Boehm, Wolfgang, Welzing, Lars, Vochem, Matthias, Hoppenz, Marc, Buehrer, Christoph, Mehler, Katrin, Stuetzer, Hartmut, Franklin, Jeremy ORCID: 0000-0003-1536-0925, Stoehr, Andreas, Herting, Egbert and Roth, Bernhard (2015). Nonintubated Surfactant Application vs Conventional Therapy in Extremely Preterm Infants A Randomized Clinical Trial. JAMA Pediatr., 169 (8). S. 723 - 731. CHICAGO: AMER MEDICAL ASSOC. ISSN 2168-6211

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Abstract

IMPORTANCE Treatment of respiratory distress syndrome in premature infants with continuous positive airway pressure (CPAP) preserves surfactant and keeps the lung open but is insufficient in severe surfactant deficiency. Traditional surfactant administration is related to short periods of positive pressure ventilation and implies the risk of lung injury. CPAP with surfactant but without any positive pressure ventilation may work synergistically. This randomized trial investigated a less invasive surfactant application protocol (LISA). OBJECTIVE To test the hypothesis that LISA increases survival without bronchopulmonary dysplasia (BPD) at 36 weeks' gestational age in extremely preterm infants. DESIGN, SETTING, AND PARTICIPANTS The Nonintubated Surfactant Application trial was a multicenter, randomized, clinical, parallel-group study conducted between April 15, 2009, and March 25, 2012, in 13 level III neonatal intensive care units in Germany. The final follow-up date was June 21, 2012. Participants included 211 of 558 eligible (37.8%) spontaneously breathing preterm infants born between 23.0 and 26.8 weeks' gestational age with signs of respiratory distress syndrome. In an intention-to-treat design, infants were randomly assigned to receive surfactant either via a thin endotracheal catheter during CPAP-assisted spontaneous breathing (intervention group) or after conventional endotracheal intubation during mechanical ventilation (control group). Analysis was conducted from September 6, 2012, to June 20, 2013. INTERVENTION LISA via a thin catheter. MAIN OUTCOMES AND MEASURES Survival without BPD at 36 weeks' gestational age. RESULTS Of 211 infants who were randomized, 104 were randomized to the control group and 107 to the LISA group. Of the infants who received LISA, 72 (67.3%) survived without BPD compared with 61 (58.7%) of those in the control group. The reduction in absolute risk was 8.6%(95% CI, -5.0% to 21.9%; P = .20). Intervention group infants were less frequently intubated (80 infants [74.8%] vs 103 [99.0%]; P < .001) and required fewer days of mechanical ventilation. Significant reductions were seen in pneumothorax (5 of 105 intervention group infants [4.8%] vs 13 of 103 12.6%]; P = .04) and severe intraventricular hemorrhage (11 infants [10.3%] vs 23 [22.1%]; P = .02), and the combined survival without severe adverse events was increased in the intervention group (54 infants [50.5%] vs 37 [35.6%]; P = .02; absolute risk reduction, 14.9; 95% CI, 1.4 to 28.2). CONCLUSIONS AND RELEVANCE LISA did not increase survival without BPD but was associated with increased survival without major complications. Because major complications are related to lifelong disabilities, LISA may be a promising therapy for extremely preterm infants.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Kribs, Angela UNSPECIFIED UNSPECIFIED UNSPECIFIED Roll, Claudia UNSPECIFIED UNSPECIFIED UNSPECIFIED Goepel, Wolfgang UNSPECIFIED UNSPECIFIED UNSPECIFIED Wieg, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Groneck, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Laux, Reinhard UNSPECIFIED UNSPECIFIED UNSPECIFIED Teig, Norbert UNSPECIFIED UNSPECIFIED UNSPECIFIED Hoehn, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Boehm, Wolfgang UNSPECIFIED UNSPECIFIED UNSPECIFIED Welzing, Lars UNSPECIFIED UNSPECIFIED UNSPECIFIED Vochem, Matthias UNSPECIFIED UNSPECIFIED UNSPECIFIED Hoppenz, Marc UNSPECIFIED UNSPECIFIED UNSPECIFIED Buehrer, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Mehler, Katrin UNSPECIFIED UNSPECIFIED UNSPECIFIED Stuetzer, Hartmut UNSPECIFIED UNSPECIFIED UNSPECIFIED Franklin, Jeremy UNSPECIFIED orcid.org/0000-0003-1536-0925 UNSPECIFIED Stoehr, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Herting, Egbert UNSPECIFIED UNSPECIFIED UNSPECIFIED Roth, Bernhard UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-398092
DOI:	10.1001/jamapediatrics.2015.0504
Journal or Publication Title:	JAMA Pediatr.
Volume:	169
Number:	8
Page Range:	S. 723 - 731
Date:	2015
Publisher:	AMER MEDICAL ASSOC
Place of Publication:	CHICAGO
ISSN:	2168-6211
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language BRONCHOPULMONARY DYSPLASIA; BIRTH; VENTILATION; INTUBATION; MANAGEMENT; CPAP Multiple languages Pediatrics Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/39809