Evidence map›Paper›PMID 34332629›Full record

ArticleTrials2021

Effects of an exclusive human-milk diet in preterm neonates on early vascular aging risk factors (NEOVASC): study protocol for a multicentric, prospective, randomized, controlled, open, and parallel group clinical trial.

Wolfgang Mitterer, Christoph Binder, Anya Blassnig-Ezeh, Lorenz Auer-Hackenberg, Angelika Berger, Burkhard Simma, Martin Wald, Martin Lee, Ursula Kiechl-Kohlendorfer

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04413994 (Effects of an Exclusive Human-milk Diet in Preterm NEOnates on Early VASCular Aging Risk Factors), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 37% 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.

NCT04413994 narecruitingnot on this map

Effects of an Exclusive Human-milk Diet in Preterm NEOnates on Early VASCular Aging Risk Factors (NEOVASC)

TypeinterventionalSponsorProlacta BioscienceRan2020 to 2028Enrolled200ConditionsPrematurity, Vascular AgingArmsHumavant
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 citations in OpenAlex.

  1. Trial
  2. Article
  3. Observational
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

9 authors at 5 institutions in 2 countries.

Wolfgang MittererVASCage GmbH, Research Centre on Vascular Ageing and Stroke, Innrain 66a, 6020, Innsbruck, Austria.
Christoph BinderDepartment of Pediatrics and Adolescent Medicine, Comprehensive Center for Pediatrics, Division of Neonatology, Pediatric Intensive Care & Neuropediatrics, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.
Anya Blassnig-EzehDepartment of Pediatrics, Academic Teaching Hospital Feldkirch, Carinagasse 47, 6800, Feldkirch, Austria.
Lorenz Auer-HackenbergDepartment of Pediatrics, Division of Neonatology, Paracelsus Medical University Salzburg, Strubergasse 21, 5020, Salzburg, Austria.
Angelika BergerDepartment of Pediatrics and Adolescent Medicine, Comprehensive Center for Pediatrics, Division of Neonatology, Pediatric Intensive Care & Neuropediatrics, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.
Burkhard SimmaDepartment of Pediatrics, Academic Teaching Hospital Feldkirch, Carinagasse 47, 6800, Feldkirch, Austria.
Martin WaldDepartment of Pediatrics, Division of Neonatology, Paracelsus Medical University Salzburg, Strubergasse 21, 5020, Salzburg, Austria.
Martin LeeFielding School of Public Health (UCLA), 650 Charles E. Young Dr. South, Los Angeles, CA, 90095-1772, USA.
Ursula Kiechl-KohlendorferDepartment of Pediatrics II (Neonatology), Medical University of Innsbruck, Anichstraße 35, 6020, Innsbruck, Austria. ursula.kohlendorfer@i-med.ac.at.ORCID http://orcid.org/0000-0003-0433-6196
Innsbruck Medical University · ATLandeskrankenhaus Feldkirch · ATMedical University of Vienna · ATParacelsus Medical University · ATHighland Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPreterm birth accounts for approximately 11% of all livebirths globally. Due to improvements in perinatal care, more than 95% of these infants now survive into adulthood. Research has indicated a robust association between prematurity and increased cardiovascular risk factors and cardiovascular mortality. While the innate adverse effects of prematurity on these outcomes have been demonstrated, therapeutic strategies on the mitigation of these concerning developments are lacking. The primary objective of the NEOVASC clinical trial is therefore to investigate whether the administration of a prolonged exclusive human-milk diet in preterm infants is capable of alleviating the harmful effects of preterm birth on the early development of cardiovascular risk factors.

methodsThe NEOVASC study is a multicentric, prospective, randomized, controlled, open, and parallel group clinical trial conducted in four Austrian tertiary neonatal care facilities. The purpose of the present trial is to investigate the effects of a prolonged exclusive human-milk-diet devoid of bovine-milk-based food components on cardiovascular and metabolic risk factors at 1, 2, and 5 years of corrected age. Primary outcomes include assessments of fasting blood glucose levels, blood pressure levels, and the distensibility of the descending aorta using validated echocardiographic protocols at 5 years of corrected age. The test group, which consists of 200 preterm infants, will therefore be compared to a control group of 100 term-born infants and a historical control group recruited previously. DISCUSSION: Given the emerging implications of an increased cardiovascular risk profile in the potentially growing population of preterm infants, further research on the mitigation of long-term morbidities in formerly preterm infants is urgently warranted. Further optimizing preterm infants' nutrition by removing bovine-milk-based food components may therefore be an interesting approach worth pursuing.

trial registrationClinicalTrials.gov NCT04413994 . Registered on 4 June 2020.

Indexed as

Infant, PrematurePremature BirthAdultAgingAnimalsAustriaCattleDietFemaleHumansInfantInfant, NewbornMilk, HumanPregnancyProspective StudiesRandomized Controlled Trials as TopicCardiovascular riskHuman milkHuman-milk-based fortifierNeonatologyPrematurityPreterm

Identifiers

PMID34332629
PMCPMC8325296
OpenAlexW3187076163

What OpenQuestion holds

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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.