Evidence map›Paper›PMID 31435957›Full record

Trial reportActa paediatrica (Oslo, Norway : 1992)2020

Comparative study of preterm infants fed new and existing human milk fortifiers showed favourable markers of gastrointestinal status.

Jacques Rigo, Jean-Michel Hascoët, Jean-Charles Picaud, Fabio Mosca, Amandine Rubio, Elie Saliba, Michaël Radkë, Umberto Simeoni, Bernard Guillois, Nicholas P Hays and 3 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Acta paediatrica (Oslo, Norway : 1992), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 41% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. 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 10 institutions in 6 countries.

Jacques RigoDepartment of Neonatology, CHR Citadelle, University of Liège, Liège, Belgium.
Jean-Michel HascoëtMaternité Régionale Universitaire A. Pinard, CHRU, Nancy, France.
Jean-Charles PicaudService de Neonatologie, Hôpital de la Croix Rousse, Lyon, France.ORCID 0000-0002-4999-6668
Fabio MoscaNeonatal Intensive Care Unit, Department of Clinical Science and Community Health, Fondazione IRCCS "Ca' Granda" Ospedale Maggiore Policlinico, University of Milan, Milano, Italy.ORCID 0000-0001-6477-0299
Amandine RubioHôpital Couple Enfant, CHU de Grenoble, Grenoble, France.
Elie SalibaHôpital Clocheville, CHU de Tours, Tours, France.ORCID 0000-0001-7538-8642
Michaël RadkëKlinikum Westbrandenburg GmbH, Potsdam, Germany.
Umberto SimeoniCentre Hospitalier Universitaire Vaudois, University of Lausanne, Lausanne, Switzerland.ORCID 0000-0003-0730-9337
Bernard GuilloisHôpital Clemenceau, CHU de Caen, Caen, France.
Nicholas P HaysNestlé Product Technology Center - Nutrition, La Tour-de-Peilz, Switzerland.ORCID 0000-0002-7322-1600
Mickaël HartwegNestlé Clinical Development Unit, Lausanne, Switzerland.
Claude BilleaudCIC Pédiatrique 1401 CHU, Bordeaux, France.ORCID 0000-0002-4938-8275
Johannes SpalingerChildren's Hospital of Lucerne, Lucerne, Switzerland.ORCID 0000-0001-9036-6118
Nestlé (Switzerland) · CHBoston Children's Hospital · USCentre Hospitalier Universitaire de Caen Normandie · FRCentre Hospitalier Universitaire de Grenoble · FRCentre Hospitalier Universitaire de Tours · FRHôpital de la Croix-Rousse · FRKlinikum Oldenburg · DEUniversity Hospital of Lausanne · CHUniversity of Liège · BEUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimThis study examined the influence of different human milk fortifiers on biomarkers of gastrointestinal immaturity and inflammation in preterm infants.

methodsWe report secondary outcomes from a controlled, double-blind, randomised, parallel group study conducted from 2011 to 2014 in neonatal intensive care units at 11 metropolitan hospitals in France, Belgium, Germany, Switzerland and Italy. Preterm infants born at up to 32 weeks or weighing up to 1500 g were randomised to a new powdered human milk fortifier (n = 77) or a control fortifier (n = 76) for a minimum of 21 days. We analysed faecal markers of gut inflammation, namely alpha-1 antitrypsin and calprotectin, and maturity, namely elastase-1.

resultsFaecal alpha-1 antitrypsin was slightly lower in the new than control fortifier group after 21 days of full enteral feeding, with a geometric mean and standard deviation of 1.52 ± 1.32 vs 1.82 ± 1.44 mg/g stools (P = .01). There was no significant difference in faecal calprotectin (median [Q1-Q3] of 296 [136-565] μg/g stools in both groups combined at study day 21). Faecal elastase-1 was lower in the new fortifier than control fortifier group (202.5 ± 1.6 vs 257.7 ± 1.5 μg/g stools, P = .016).

conclusionMean values for each parameter were within the ranges in healthy term infants, indicating favourable markers of gastrointestinal status in both groups. In addition, for faecal calprotectin, the relatively high concentration observed in preterm infants fed fortified human milk suggests that the threshold level for detecting necrotising enterocolitis should be revised.

Indexed as

Infant, PrematureMilk, HumanBelgiumBiomarkersFood, FortifiedFranceGermanyHumansInfantInfant, NewbornItalySwitzerlandWeight GainBiomarkersalpha-1 antitrypsincalprotectinelastase-1low birthweight infantprematurity

Identifiers

PMID31435957
PMCPMC7028100
OpenAlexW2969546724

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.