PT  - JOURNAL ARTICLE
AU  - Justyna Romańska
AU  - Wojciech Margas
AU  - Renata Bokiniec
AU  - Paweł Krajewski
AU  - Joanna Seliga-Siwecka
TI  - 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
AID  - 10.1136/bmjopen-2019-030167
DP  - 2019 Sep 01
TA  - BMJ Open
PG  - e030167
VI  - 9
IP  - 9
4099  - http://bmjopen.bmj.com/content/9/9/e030167.short
4100  - http://bmjopen.bmj.com/content/9/9/e030167.full
SO  - BMJ Open2019 Sep 01; 9
AB  - 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.