Evidence map›Paper›PMID 31530607›Full record

ArticleBMJ open2019

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.

Justyna Romańska, Wojciech Margas, Renata Bokiniec, Paweł Krajewski, Joanna Seliga-Siwecka

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03730883 (The Effect of Early Versus Standard Central Line Removal on Growth of Very Low Birth Weight Premature Infants), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03730883 naunknown statusnot on this map

The Effect of Early Versus Standard Central Line Removal on Growth of Very Low Birth Weight Premature Infants: A Non-inferiority, Randomized Controlled Trial

TypeinterventionalSponsorPrincess Anna Mazowiecka Hospital, Warsaw, PolandRan2019 to 2024Enrolled214ConditionsGrowth Failure, CLABSI - Central Line Associated Bloodstream InfectionArmsCentral line removal at 100ml/kg/day., Central line removal at 140ml/kg/day.
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Justyna RomańskaDivision of Neonatology and Neonatal Intensive Care Unit of First Department of Obstetrics and Gynecology, Medical University of Warsaw, Warszawa, Poland.ORCID 0000-0001-8503-6229
Wojciech MargasHTA Consulting, Cracow, Poland.
Renata BokiniecNeonatal and Intensive Care Department, Medical University of Warsaw, Warszawa, Poland.
Paweł KrajewskiDivision of Neonatology and Neonatal Intensive Care Unit of First Department of Obstetrics and Gynecology, Medical University of Warsaw, Warszawa, Poland.
Joanna Seliga-SiweckaNeonatal and Intensive Care Department, Medical University of Warsaw, Warszawa, Poland joanna.seliga@wum.edu.pl.ORCID 0000-0002-4628-0541

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionUncertainty 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.

Indexed as

Adaptation, PhysiologicalEnteral NutritionEnterocolitis, NecrotizingEquivalence Trials as TopicHumansInfant, NewbornInfant, PrematureInfant, Very Low Birth WeightMulticenter Studies as TopicParenteral NutritionPolandcentral venous cathetergrowthinfectionparenteral nutritionpreterm infants

Identifiers

PMID31530607
PMCPMC6756345

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.