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 to...
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BMJ Publishing Group
2019-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/9/e030167.full |
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| author | Paweł Krajewski Justyna Romańska Wojciech Margas Joanna Seliga-Siwecka |
| author_facet | Paweł Krajewski Justyna Romańska Wojciech Margas Joanna Seliga-Siwecka |
| author_sort | Paweł Krajewski |
| collection | DOAJ |
| 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 | Article |
| id | doaj-art-aaabfb4c4e40417895663c6db34e7306 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-aaabfb4c4e40417895663c6db34e73062025-08-20T02:48:45ZengBMJ Publishing GroupBMJ Open2044-60552019-09-019910.1136/bmjopen-2019-030167Effect of early versus standard central line removal on growth of very low birthweight premature infants: a protocol for a non-inferiority randomised controlled trialPaweł Krajewski0Justyna Romańska1Wojciech Margas2Joanna Seliga-Siwecka31 Division of Neonatology and Neonatal Intensive Care Unit of First Department of Obstetrics and Gynecology, Medical University of Warsaw, Warszawa, Poland1 Division of Neonatology and Neonatal Intensive Care Unit of First Department of Obstetrics and Gynecology, Medical University of Warsaw, Warszawa, Poland2 HTA Consulting, Cracow, Poland3 Neonatal and Intensive Care Department, Medical University of Warsaw, Warszawa, PolandIntroduction 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.https://bmjopen.bmj.com/content/9/9/e030167.full |
| spellingShingle | Paweł Krajewski Justyna Romańska Wojciech Margas Joanna Seliga-Siwecka 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 BMJ Open |
| 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 |
| url | https://bmjopen.bmj.com/content/9/9/e030167.full |
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