Three-center feasibility of lung clearance index in infants and preschool children with cystic fibrosis and other lung diseases

Mirjam Stahl; Simon Y. Graeber; Cornelia Joachim; Sandra Barth; Isabell Ricklefs; Gesa Diekmann; Matthias V. Kopp; Lutz Naehrlich; Marcus A. Mall

doi:10.1016/j.jcf.2017.08.001

Three-center feasibility of lung clearance index in infants and preschool children with cystic fibrosis and other lung diseases

Mirjam Stahl^*, Simon Y. Graeber, Cornelia Joachim, Sandra Barth, Isabell Ricklefs, Gesa Diekmann, Matthias V. Kopp, Lutz Naehrlich, Marcus A. Mall

^*Corresponding author for this work

Clinic of Pediatric and Adolescent Medicine

14 Citations (Scopus)

Abstract

Background: Lung clearance index (LCI) detects early ventilation inhomogeneity and has been suggested as sensitive endpoint in multicenter intervention trials in infants and preschoolers with cystic fibrosis (CF). However, the feasibility of multicenter LCI in this age group has not been determined. We, therefore, investigated the feasibility of LCI in infants and preschoolers with and without CF in a three-center setting. Methods: Following central training, standardized SF₆-MBW measurements were performed in 73 sedated children (10 controls, 49 with CF and 14 with other lung diseases), mean age 2.3 ± 1.2 years across three centers, and data were analyzed centrally. Results: Overall success rate of LCI measurements was 91.8% ranging from 78.9% to 100% across study sites. LCI was increased in patients with CF (P < 0.05) and with other lung diseases (P < 0.05) compared to controls. Conclusion: Our results support feasibility of LCI as multicenter endpoint in clinical trials in infants and preschoolers with CF.

Original language	English
Journal	Journal of Cystic Fibrosis
Volume	17
Issue number	2
Pages (from-to)	249-255
Number of pages	7
ISSN	1569-1993
DOIs	https://doi.org/10.1016/j.jcf.2017.08.001
Publication status	Published - 03.2018

Research Areas and Centers

Academic Focus: Center for Infection and Inflammation Research (ZIEL)

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10.1016/j.jcf.2017.08.001

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@article{7023cd046e4b493cba69a29ecb59b449,

title = "Three-center feasibility of lung clearance index in infants and preschool children with cystic fibrosis and other lung diseases",

abstract = "Background: Lung clearance index (LCI) detects early ventilation inhomogeneity and has been suggested as sensitive endpoint in multicenter intervention trials in infants and preschoolers with cystic fibrosis (CF). However, the feasibility of multicenter LCI in this age group has not been determined. We, therefore, investigated the feasibility of LCI in infants and preschoolers with and without CF in a three-center setting. Methods: Following central training, standardized SF6-MBW measurements were performed in 73 sedated children (10 controls, 49 with CF and 14 with other lung diseases), mean age 2.3 ± 1.2 years across three centers, and data were analyzed centrally. Results: Overall success rate of LCI measurements was 91.8% ranging from 78.9% to 100% across study sites. LCI was increased in patients with CF (P < 0.05) and with other lung diseases (P < 0.05) compared to controls. Conclusion: Our results support feasibility of LCI as multicenter endpoint in clinical trials in infants and preschoolers with CF.",

author = "Mirjam Stahl and Graeber, {Simon Y.} and Cornelia Joachim and Sandra Barth and Isabell Ricklefs and Gesa Diekmann and Kopp, {Matthias V.} and Lutz Naehrlich and Mall, {Marcus A.}",

note = "Funding Information: This work was supported in part by the German Ministry for Education and Research ( 82DZL00401 , 82DZL0040A1 , 82DZL10106 , 82DZL10501 ), the German Cystic Fibrosis Association Mukoviszidose e.V. (grant 15/01 ), the Dietmar Hopp Foundation and the Mukoviszidose F{\"o}rderverein Giessen e.V . The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Publisher Copyright: {\textcopyright} 2017 European Cystic Fibrosis Society Copyright: Copyright 2018 Elsevier B.V., All rights reserved.",

year = "2018",

month = mar,

doi = "10.1016/j.jcf.2017.08.001",

language = "English",

volume = "17",

pages = "249--255",

journal = "Journal of Cystic Fibrosis",

issn = "1569-1993",

publisher = "Elsevier B.V.",

number = "2",

}

TY - JOUR

T1 - Three-center feasibility of lung clearance index in infants and preschool children with cystic fibrosis and other lung diseases

AU - Stahl, Mirjam

AU - Graeber, Simon Y.

AU - Joachim, Cornelia

AU - Barth, Sandra

AU - Ricklefs, Isabell

AU - Diekmann, Gesa

AU - Kopp, Matthias V.

AU - Naehrlich, Lutz

AU - Mall, Marcus A.

N1 - Funding Information: This work was supported in part by the German Ministry for Education and Research ( 82DZL00401 , 82DZL0040A1 , 82DZL10106 , 82DZL10501 ), the German Cystic Fibrosis Association Mukoviszidose e.V. (grant 15/01 ), the Dietmar Hopp Foundation and the Mukoviszidose Förderverein Giessen e.V . The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Publisher Copyright: © 2017 European Cystic Fibrosis Society Copyright: Copyright 2018 Elsevier B.V., All rights reserved.

PY - 2018/3

Y1 - 2018/3

N2 - Background: Lung clearance index (LCI) detects early ventilation inhomogeneity and has been suggested as sensitive endpoint in multicenter intervention trials in infants and preschoolers with cystic fibrosis (CF). However, the feasibility of multicenter LCI in this age group has not been determined. We, therefore, investigated the feasibility of LCI in infants and preschoolers with and without CF in a three-center setting. Methods: Following central training, standardized SF6-MBW measurements were performed in 73 sedated children (10 controls, 49 with CF and 14 with other lung diseases), mean age 2.3 ± 1.2 years across three centers, and data were analyzed centrally. Results: Overall success rate of LCI measurements was 91.8% ranging from 78.9% to 100% across study sites. LCI was increased in patients with CF (P < 0.05) and with other lung diseases (P < 0.05) compared to controls. Conclusion: Our results support feasibility of LCI as multicenter endpoint in clinical trials in infants and preschoolers with CF.

AB - Background: Lung clearance index (LCI) detects early ventilation inhomogeneity and has been suggested as sensitive endpoint in multicenter intervention trials in infants and preschoolers with cystic fibrosis (CF). However, the feasibility of multicenter LCI in this age group has not been determined. We, therefore, investigated the feasibility of LCI in infants and preschoolers with and without CF in a three-center setting. Methods: Following central training, standardized SF6-MBW measurements were performed in 73 sedated children (10 controls, 49 with CF and 14 with other lung diseases), mean age 2.3 ± 1.2 years across three centers, and data were analyzed centrally. Results: Overall success rate of LCI measurements was 91.8% ranging from 78.9% to 100% across study sites. LCI was increased in patients with CF (P < 0.05) and with other lung diseases (P < 0.05) compared to controls. Conclusion: Our results support feasibility of LCI as multicenter endpoint in clinical trials in infants and preschoolers with CF.

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U2 - 10.1016/j.jcf.2017.08.001

DO - 10.1016/j.jcf.2017.08.001

M3 - Journal articles

C2 - 28811149

AN - SCOPUS:85028304351

SN - 1569-1993

VL - 17

SP - 249

EP - 255

JO - Journal of Cystic Fibrosis

JF - Journal of Cystic Fibrosis

IS - 2

ER -

Three-center feasibility of lung clearance index in infants and preschool children with cystic fibrosis and other lung diseases

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