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Effect of early versus standard central line removal on growth of very low birthweight premature infants: a protocol for a non-inferiority randomised controlled trial
INTRODUCTION: Uncertainty exists regarding the optimal time for removal of central lines used to provide parenteral nutrition in preterm infants. The aim of this study is to determine whether earlier central line removal is non-inferior to its removal after reaching full enteral intake, in respect t...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6756345/ https://www.ncbi.nlm.nih.gov/pubmed/31530607 http://dx.doi.org/10.1136/bmjopen-2019-030167 |
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author | Romańska, Justyna Margas, Wojciech Bokiniec, Renata Krajewski, Paweł Seliga-Siwecka, Joanna |
author_facet | Romańska, Justyna Margas, Wojciech Bokiniec, Renata Krajewski, Paweł Seliga-Siwecka, Joanna |
author_sort | Romańska, Justyna |
collection | PubMed |
description | INTRODUCTION: Uncertainty exists regarding the optimal time for removal of central lines used to provide parenteral nutrition in preterm infants. The aim of this study is to determine whether earlier central line removal is non-inferior to its removal after reaching full enteral intake, in respect to growth outcome of preterm infants. METHODS AND ANALYSIS: Very low birthweight premature infants will be recruited. Eligible infants will be randomised in equal proportions between two groups. In the intervention group central lines will be removed when infants reach 100 mL/kg/day of enteral intake. In the control group central lines will be removed when infants reach 140 mL/kg/day of enteral intake (full enteral intake). The primary outcome measure will be the difference between the two groups in weight at 36 weeks’ postmenstrual age. Non-inferiority will be declared if the mean weight of children in the intervention group will be no worse than the mean weight of children from the control group, by a margin of −210 g. ETHICS AND DISSEMINATION: The Bioethics Committee of the Medical University of Warsaw approved the study protocol prior to recruitment. The findings of this trial will be submitted to a peer-reviewed journal (neonatology, paediatrics or nutrition). Abstracts will be submitted to relevant national and international conferences. TRIAL REGISTRATION NUMBER: NCT03730883. PROTOCOL VERSION: Version 3. 14.08.2019. |
format | Online Article Text |
id | pubmed-6756345 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-67563452019-10-07 Effect of early versus standard central line removal on growth of very low birthweight premature infants: a protocol for a non-inferiority randomised controlled trial Romańska, Justyna Margas, Wojciech Bokiniec, Renata Krajewski, Paweł Seliga-Siwecka, Joanna BMJ Open Paediatrics INTRODUCTION: Uncertainty exists regarding the optimal time for removal of central lines used to provide parenteral nutrition in preterm infants. The aim of this study is to determine whether earlier central line removal is non-inferior to its removal after reaching full enteral intake, in respect to growth outcome of preterm infants. METHODS AND ANALYSIS: Very low birthweight premature infants will be recruited. Eligible infants will be randomised in equal proportions between two groups. In the intervention group central lines will be removed when infants reach 100 mL/kg/day of enteral intake. In the control group central lines will be removed when infants reach 140 mL/kg/day of enteral intake (full enteral intake). The primary outcome measure will be the difference between the two groups in weight at 36 weeks’ postmenstrual age. Non-inferiority will be declared if the mean weight of children in the intervention group will be no worse than the mean weight of children from the control group, by a margin of −210 g. ETHICS AND DISSEMINATION: The Bioethics Committee of the Medical University of Warsaw approved the study protocol prior to recruitment. The findings of this trial will be submitted to a peer-reviewed journal (neonatology, paediatrics or nutrition). Abstracts will be submitted to relevant national and international conferences. TRIAL REGISTRATION NUMBER: NCT03730883. PROTOCOL VERSION: Version 3. 14.08.2019. BMJ Publishing Group 2019-09-17 /pmc/articles/PMC6756345/ /pubmed/31530607 http://dx.doi.org/10.1136/bmjopen-2019-030167 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Paediatrics Romańska, Justyna Margas, Wojciech Bokiniec, Renata Krajewski, Paweł Seliga-Siwecka, Joanna Effect of early versus standard central line removal on growth of very low birthweight premature infants: a protocol for a non-inferiority randomised controlled trial |
title | Effect of early versus standard central line removal on growth of very low birthweight premature infants: a protocol for a non-inferiority randomised controlled trial |
title_full | Effect of early versus standard central line removal on growth of very low birthweight premature infants: a protocol for a non-inferiority randomised controlled trial |
title_fullStr | Effect of early versus standard central line removal on growth of very low birthweight premature infants: a protocol for a non-inferiority randomised controlled trial |
title_full_unstemmed | Effect of early versus standard central line removal on growth of very low birthweight premature infants: a protocol for a non-inferiority randomised controlled trial |
title_short | Effect of early versus standard central line removal on growth of very low birthweight premature infants: a protocol for a non-inferiority randomised controlled trial |
title_sort | effect of early versus standard central line removal on growth of very low birthweight premature infants: a protocol for a non-inferiority randomised controlled trial |
topic | Paediatrics |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6756345/ https://www.ncbi.nlm.nih.gov/pubmed/31530607 http://dx.doi.org/10.1136/bmjopen-2019-030167 |
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