Evidence map›Paper›PMID 33407269›Full record

ArticleBMC pediatrics2021

Effects of nutrition therapy on growth, inflammation and metabolism in immature infants: a study protocol of a double-blind randomized controlled trial (ImNuT).

Kristina Wendel, Helle Cecilie Viekilde Pfeiffer, Drude Merete Fugelseth, Eirik Nestaas, Magnus Domellöf, Bjorn Steen Skålhegg, Katja Benedikte Presto Elgstøen, Helge Rootwelt, Rolf Dagfinn Pettersen, Are Hugo Pripp and 3 more

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

Article in BMC pediatrics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03555019 (Effects of Nutrition Therapy on Growth, Inflammation and Metabolism in Immature Infants; a Double-blind Randomized, Controlled Trial), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.0field-weighted citation impact, top 15% 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.

NCT03555019 naactive not recruitingnot on this map

Effects of Nutrition Therapy on Growth, Inflammation and Metabolism in Immature Infants; a Double-blind Randomized, Controlled Trial

TypeinterventionalSponsorOslo University HospitalRan2018 to 2029Enrolled121ConditionsImmature Infant, Essential Fatty Acid DeficiencyArmsFormulaid, MCT-oil
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 22 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Maternal Nutrition, Toxicants, and Epigenetic Programming of Obesity Across Generations.Diabetes, metabolic syndrome and obesity : targets and therapy · 2025
    Review
  5. A ComparativeMolecules (Basel, Switzerland) · 2024
    Article
  6. Article
  7. Article
  8. Review
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

13 authors at 4 institutions in 2 countries.

Kristina WendelDepartment of Neonatal Intensive Care, Oslo University Hospital, Oslo, Norway. krwend@ous-hf.no.ORCID 0000-0002-9207-1927
Helle Cecilie Viekilde PfeifferDepartment of Neonatal Intensive Care, Oslo University Hospital, Oslo, Norway.
Drude Merete FugelsethDepartment of Neonatal Intensive Care, Oslo University Hospital, Oslo, Norway.
Eirik NestaasDepartment of Neonatal Intensive Care, Oslo University Hospital, Oslo, Norway.
Magnus DomellöfDepartment of Clinical Sciences, Pediatrics, Umea University, Umea, Sweden.
Bjorn Steen SkålheggDivision of Molecular Nutrition, Department of Nutrition, University of Oslo, Oslo, Norway.
Katja Benedikte Presto ElgstøenDepartment of Medical Biochemistry, Oslo University Hospital, Oslo, Norway.
Helge RootweltDepartment of Medical Biochemistry, Oslo University Hospital, Oslo, Norway.
Rolf Dagfinn PettersenNorwegian National Unit for Newborn Screening, Division of Pediatric and Adolescent Medicine, Oslo University Hospital, Oslo, Norway.
Are Hugo PrippOslo Centre of Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway.
Tom StirisDepartment of Neonatal Intensive Care, Oslo University Hospital, Oslo, Norway.
Sissel J MoltuDepartment of Neonatal Intensive Care, Oslo University Hospital, Oslo, Norway.
ImNuT Collaboration Group
Oslo University Hospital · NOSykehuset i Vestfold · NOUmeå University · SEUniversity of Oslo · NO

Funding

Norges Forskningsråd 260552/h10
6 · The paper itself

Abstract

backgroundCurrent nutritional management of infants born very preterm results in significant deficiency of the essential fatty acids (FAs) arachidonic acid (ARA) and docosahexaenoic acid (DHA). The impact of this deficit on brain maturation and inflammation mediated neonatal morbidities are unknown. The aim of this study is to determine whether early supply of ARA and DHA improves brain maturation and neonatal outcomes in infants born before 29 weeks of gestation.

methodsInfants born at Oslo University Hospital are eligible to participate in this double-blind randomized controlled trial. Study participants are randomized to receive an enteral FA supplement of either 0.4 ml/kg MCT-oil™ (medium chain triglycerides) or 0.4 ml/kg Formulaid™ (100 mg/kg of ARA and 50 mg/kg of DHA). The FA supplement is given from the second day of life to 36 weeks' postmenstrual age (PMA). The primary outcome is brain maturation assessed by Magnetic Resonance Imaging (MRI) at term equivalent age. Secondary outcomes include quality of growth, incidence of neonatal morbidities, cardiovascular health and neuro-development. Target sample size is 120 infants (60 per group), this will provide 80% power to detect a 0.04 difference in mean diffusivity (MD, mm DISCUSSION: Supplementation of ARA and DHA has the potential to improve brain maturation and reduce inflammation related diseases. This study is expected to provide valuable information for future nutritional guidelines for preterm infants.

trial registrationClinicaltrials.gov ID: NCT03555019 . Registered 4 October 2018- Retrospectively registered.

Indexed as

Infant, PrematureNutrition TherapyArachidonic AcidDocosahexaenoic AcidsDouble-Blind MethodHumansInfantInfant, NewbornInflammationRandomized Controlled Trials as TopicArachidonic AcidDocosahexaenoic AcidsArachidonic acidBrain maturationDocosahexaenoic acidInflammationNutritionPreterm

Identifiers

PMID33407269
PMCPMC7789285
OpenAlexW3120273355

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.