Evidence map›Paper›PMID 31996186›Full record

ArticleBMC pediatrics2020

Lactoferrin infant feeding trial_Canada (LIFT_Canada): protocol for a randomized trial of adding lactoferrin to feeds of very-low-birth-weight preterm infants.

Elizabeth V Asztalos, Keith Barrington, Abhay Lodha, William Tarnow-Mordi, Andrew Martin

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC pediatrics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03367013 (Lactoferrin Infant Feeding Trial - LIFT_Canada), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.8field-weighted citation impact, top 16% of its field
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.

NCT03367013 phase3completednot on this map

Lactoferrin Infant Feeding Trial - LIFT_Canada

TypeinterventionalSponsorDr. Elizabeth AsztalosRan2018 to 2024Enrolled453ConditionsPreterm Infant, Very Low Birth Weight Infant, Morbidity, NewbornArmsBovine Lactoferrin, No Bovine Lactoferrin added
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 22 citations in OpenAlex.

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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 at 4 institutions in 2 countries.

Elizabeth V AsztalosDepartment of Newborn and Developmental Paediatrics, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, University of Toronto, M4-230, 2075 Bayview Ave., Toronto, ON, M4N 3M5, Canada. elizabeth.asztalos@sunnybrook.ca.ORCID 0000-0002-9468-2860
Keith BarringtonDepartment of Pediatrics, Université de Montréal, Montréal, PQ, Canada.
Abhay LodhaDepartment of Pediatrics, University of Calgary, Calgary, AB, Canada.
William Tarnow-MordiNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
Andrew MartinNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
The University of Sydney · AUSunnybrook Health Science Centre · CAUniversité de Montréal · CAUniversity of Calgary · CA

Funding

CIHR PJT 152871
6 · The paper itself

Abstract

backgroundIn Canada alone, almost 3000 VLBW infants are born and treated annually with almost 1200 going onto death or survival with severe brain injury, chronic lung disorders, aggressive retinopathy of prematurity, late-onset sepsis, or significant necrotizing enterocolitis. Lactoferrin is an antimicrobial, antioxidant, anti-inflammatory iron-carrying, bifidogenic glycoprotein found in all vertebrates and in mammalian milk, leukocytes and exocrine secretions. Lactoferrin aids in creating an environment for growth of beneficial bacteria in the gut, thus reducing colonization with pathogenic bacteria. It is hypothesized that oral bovine lactoferrin (bLF), through its antimicrobial, antioxidant and anti-inflammatory properties, will reduce the rate of mortality or major morbidity in very low birth weight preterm infants.

methodLactoferrin Infant Feeding Trial_Canada (LIFT_Canada) is a multi-centre, double-masked, randomized controlled trial with the aim to enroll 500 infants whose data will be combined with the data of the 1542 infants enrolled from Lactoferrin Infant Feeding Trial_Australia/New Zealand (LIFT_ANZ) in a pooled intention-to-treat analysis. Eligible infants will be randomized and allocated to one of two treatment groups: 1) a daily dose of 200 mg/kg bLF in breast/donor human milk or formula milk until 34 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer, or until discharge home or transfer, if earlier; 2) no bLF with daily feeds. The primary outcome will be determined at 36 weeks corrected gestation for the presence of neonatal morbidity and at discharge for survival and treated retinopathy of prematurity. The duration of the trial is expected to be 36 months. DISCUSSION: Currently, there continues to be no clear answer related to the benefit of bLF in reducing mortality or any or all of the significant neonatal morbidities in very low birth weight infants. LIFT_Canada is designed with the hope that the pooled results from Australia, New Zealand, and Canada may help to clarify the situation.

trial registrationClinical Trials.Gov, Identifier: NCT03367013, Registered December 8, 2017.

Indexed as

Anti-Infective AgentsInfant, PrematureInfant, Premature, DiseasesInfant, Very Low Birth WeightLactoferrinSepsisBrain InjuriesCanadaCerebral PalsyDouble-Blind MethodEnteral NutritionEnterocolitis, NecrotizingFemaleHospital MortalityHumansInfant FormulaAnti-Infective AgentsLactoferrinLactoferrinNeonatal mortality and morbidityVery low birth weight infants

Identifiers

PMID31996186
PMCPMC6988327
OpenAlexW3003995280

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.