Application of two different nasal CPAP levels for the treatment of respiratory distress syndrome in preterm infants-"The OPTTIMMAL-Trial"-Optimizing PEEP To The IMMAture Lungs: study protocol of a randomized controlled trial

被引：12

作者：

Waitz, Markus ^{[1
]}

Engel, Corinna ^{[2
]}

Schloesser, Rolf ^{[3
]}

Rochwalsky, Ulrich ^{[3
]}

Meyer, Sascha ^{[4
]}

Zemlin, Michael ^{[4
]}

Bohnhorst, Bettina ^{[5
]}

Peter, Corinna ^{[5
]}

Hoppenz, Marc ^{[6
]}

Pabst, Thomas ^{[6
]}

Zimmer, Klaus-Peter ^{[1
]}

Franz, Axel R. ^{[2
,7
,8
]}

Ehrhardt, Harald ^{[1
,9
,10
]}

Schmidt, Annesuse ^{[1
]}

Larsen, Alexander ^{[4
]}

Hoffmann, Paul ^{[4
]}

Haertel, Christoph ^{[11
]}

Frieauff, Eric ^{[11
]}

Sandkoetter, Julia ^{[12
]}

Masjosthusmann, Katja ^{[12
,13
]}

Deindl, Philipp ^{[13
]}

Singer, Dominique

机构：

[1] Justus Liebig Univ, Dept Gen Pediat & Neonatol, Ctr Child & Adolescent Med, Feulgenstr 12, D-35392 Giessen, Germany

[2] Univ Tubingen, Ctr Pediat Clin Studies, Frondsbergstr 23, D-72070 Tubingen, Germany

[3] Goethe Univ Frankfurt, Div Neonatol, Theodor Stern Kai 7, D-60590 Frankfurt, Germany

[4] Saarland Univ, Dept Pediat & Neonatol, Neonatal Intens Care Unit, Med Ctr, Kirrbergerstr 100, D-66421 Homburg, Germany

[5] Hannover Med Sch, Div Pediat Pulmonol Allergol & Neonatol, Carl Neuberg Str 1, D-30625 Hannover, Germany

[6] Hosp Cologne, Neonatol & Pediat Intens Care Med, Amsterdamer Str 59, D-50735 Cologne, Germany

[7] Univ Tubingen, Dept Neonatol, Calwerstr 7, D-72076 Tubingen, Germany

[8] Univ Tubingen, Ctr Pediat Clin Studies, Calwerstr 7, D-72076 Tubingen, Germany

[9] Univ Giessen, German Ctr Lung Res DZL, Feulgenstr 12, D-35392 Giessen, Germany

[10] Marburg Lung Ctr UGMLC, Feulgenstr 12, D-35392 Giessen, Germany

[11] Univ Wurzburg, Univ Childrens Hosp, Josef Schneider Str 2, D-97080 Wurzburg, Germany

[12] Univ Childrens Hosp Muenster, Dept Gen Pediat, Albert Schweitzer Campus 1, D-48149 Munster, Germany

[13] Univ Med Ctr Hamburg Eppendorf, Dept Pediat, Div Neonatol & Pediat Intens Care, Martinistr 52, D-20246 Hamburg, Germany

来源：

TRIALS | 2020年 / 21卷 / 01期

关键词：

Nasal CPAP; RDS; Preterm infants; PEEP; POSITIVE-PRESSURE VENTILATION; END-EXPIRATORY PRESSURE; BRONCHOPULMONARY DYSPLASIA; SURFACTANT; BIRTH; RESUSCITATION; GUIDELINES; MANAGEMENT; SUPPORT; LAMBS;

D O I：

10.1186/s13063-020-04660-0

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Background: Nasal continuous positive airway pressure (CPAP) applies positive end-expiratory pressure (PEEP) and has been shown to reduce the need for intubation and invasive mechanical ventilation in very low birth weight infants with respiratory distress syndrome. However, CPAP failure rates of 50% are reported in large randomized controlled trials. A possible explanation for these failure rates is the application of insufficient low levels of PEEP during nasal CPAP treatment to maintain adequate functional residual capacity shortly after birth. The optimum PEEP level to treat symptoms of respiratory distress in very low birth weight infants has not been assessed in clinical studies. The aim of the study is to compare two different PEEP levels during nasal CPAP treatment in preterm infants. Methods: In this randomized multicenter trial, 216 preterm infants born at 26 + 0-29 + 6 gestational weeks will be allocated to receive a higher (6-8 cmH(2)O) or a lower (3-5 cmH(2)O) PEEP during neonatal resuscitation and the first 120 h of life. The PEEP level within each group will be titrated throughout the intervention based on the FiO(2) (fraction of inspired oxygen concentration) requirements to keep oxygenation within the target range. The primary outcome is defined as the need for intubation and mechanical ventilation for > 1 h or being not ventilated but reaching one of the two pre-defined CPAP failure criteria (FiO(2) > 0.5 for > 1 h or pCO(2) >= 70 mmHg in two consecutive blood gas analyses at least 2 h apart). Discussion: Based on available data from the literature, the optimum level of PEEP that most effectively treats respiratory distress syndrome in preterm infants is unknown, since the majority of large clinical trials applied a wide range of PEEP levels (4-8 cmH(2)O). The rationale for our study hypothesis is that the early application of a higher PEEP level will more effectively counteract the collapsing properties of the immature and surfactant-deficient lungs and that the level of inspired oxygen may serve as a surrogate marker to guide PEEP titration. Finding the optimum noninvasive continuous distending pressure during early nasal CPAP is required to improve CPAP efficacy and as a consequence to reduce the exposure to ventilator-induced lung injury and the incidence of chronic lung disease in this vulnerable population of very preterm infants.

引用

页数：14

共 29 条

[1] Variation in Positive End-Expiratory Pressure Levels for Mechanically Ventilated Extremely Low Birth Weight Infants [J].