Universität zu Köln

Goepel, Wolfgang, Kribs, Angela, Ziegler, Andreas ORCID: 0000-0002-8386-5397, Laux, Reinhard, Hoehn, Thomas, Wieg, Christian, Siegel, Jens, Avenarius, Stefan, von der Wense, Axel, Vochem, Matthias, Groneck, Peter, Weller, Ursula, Moeller, Jens, Haertel, Christoph, Haller, Sebastian, Roth, Bernhard and Herting, Egbert (2011). Avoidance of mechanical ventilation by surfactant treatment of spontaneously breathing preterm infants (AMV): an open-label, randomised, controlled trial. Lancet, 378 (9803). S. 1627 - 1635. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1474-547X

Full text not available from this repository.

Abstract

Background Surfactant is usually given to mechanically ventilated preterm infants via an endotracheal tube to treat respiratory distress syndrome. We tested a new method of surfactant application to spontaneously breathing preterm infants to avoid mechanical ventilation. Method In a parallel-group, randomised controlled trial, 220 preterm infants with a gestational age between 26 and 28 weeks and a birthweight less than 1.5 kg were enrolled in 12 German neonatal intensive care units. Infants were independently randomised in a 1:1 ratio with variable block sizes, to standard treatment or intervention, and randomisation was stratified according to centre and multiple birth status. Masking was not possible. Infants were stabilised with continuous positive airway pressure and received rescue intubation if necessary. In the intervention group, infants received surfactant treatment during spontaneous breathing via a thin catheter inserted into the trachea by laryngoscopy if they needed a fraction of inspired oxygen more than 0.30. The primary endpoint was need for any mechanical ventilation, or being not ventilated but having a partial pressure of carbon dioxide more than 65 mm Hg (8.6 kPa) or a fraction of inspired oxygen more than 0.60, or both, for more than 2 h between 25 h and 72 h of age. Analysis was by intention to treat. This study is registered, number ISRCTN05025922. Findings 108 infants were assigned to the intervention group and 112 infants to the standard treatment group. All infants were analysed. On day 2 or 3 after birth, 30 (28%) infants in the intervention group were mechanically ventilated versus 51 (46%) in the standard treatment group (number needed to treat 6, 95% CI 3-20, absolute risk reduction 0.18, 95% CI 0.30-0.05, p=0.008). 36 (33%) infants in the intervention group were mechanically ventilated during their stay in the hospital compared with 82 (73%) in the standard treatment group (number needed to treat: 3, 95% CI 2-4, p<0.0001). The intervention group had significantly fewer median days on mechanical ventilation, (0 days. IQR 0-3 vs 2 days, 0-5) and a lower need for oxygen therapy at 28 days (30 infants [30%] vs 49 infants [45%], p=0.032) compared with the standard treatment group. We recorded no differences between groups for mortality (seven deaths in the intervention group vs five in the standard treatment group) and serious adverse events (21 vs 28). Interpretation The application of surfactant via a thin catheter to spontaneously breathing preterm infants receiving continuous positive airway pressure reduces the need for mechanical ventilation.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Goepel, Wolfgang UNSPECIFIED UNSPECIFIED UNSPECIFIED Kribs, Angela UNSPECIFIED UNSPECIFIED UNSPECIFIED Ziegler, Andreas UNSPECIFIED orcid.org/0000-0002-8386-5397 UNSPECIFIED Laux, Reinhard UNSPECIFIED UNSPECIFIED UNSPECIFIED Hoehn, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Wieg, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Siegel, Jens UNSPECIFIED UNSPECIFIED UNSPECIFIED Avenarius, Stefan UNSPECIFIED UNSPECIFIED UNSPECIFIED von der Wense, Axel UNSPECIFIED UNSPECIFIED UNSPECIFIED Vochem, Matthias UNSPECIFIED UNSPECIFIED UNSPECIFIED Groneck, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Weller, Ursula UNSPECIFIED UNSPECIFIED UNSPECIFIED Moeller, Jens UNSPECIFIED UNSPECIFIED UNSPECIFIED Haertel, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Haller, Sebastian UNSPECIFIED UNSPECIFIED UNSPECIFIED Roth, Bernhard UNSPECIFIED UNSPECIFIED UNSPECIFIED Herting, Egbert UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-485558
DOI:	10.1016/S0140-6736(11)60986-0
Journal or Publication Title:	Lancet
Volume:	378
Number:	9803
Page Range:	S. 1627 - 1635
Date:	2011
Publisher:	ELSEVIER SCIENCE INC
Place of Publication:	NEW YORK
ISSN:	1474-547X
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language RESPIRATORY-DISTRESS-SYNDROME; POSITIVE AIRWAY PRESSURE; LARYNGEAL MASK AIRWAY; BIRTH-WEIGHT INFANTS; BRONCHOPULMONARY DYSPLASIA; ENDOTRACHEAL INTUBATION; NASAL CPAP; THERAPY; MULTICENTER; FAILURE Multiple languages Medicine, General & Internal Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/48555