Evidence map›Paper›PMID 41034647›Full record

Trial reportPediatric research2026

Early gut microbiome composition of very preterm infants randomised to receive human milk volumes of 60 ml/kg/day or more within the first 36 hours after birth.

Ariel A Salas, Christopher J Stewart, Gregory R Young

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Pediatric research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04337710 (Exclusive Enteral Nutrition in Preterm Neonates- A Randomized Controlled Trial), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT04337710 nacompletednot on this map

Exclusive Enteral Nutrition in Preterm Neonates- A Randomized Controlled Trial

TypeinterventionalSponsorUniversity of Alabama at BirminghamRan2021 to 2025Enrolled102ConditionsPremature, Infant, Light-for-dates, Enteral Feeding IntoleranceArmsExclusive Enteral Nutrition, Progressive Enteral Nutrition
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

3 authors.

Ariel A SalasDivision of Neonatology, University of Alabama at Birmingham, Birmingham, AL, USA. asalas@uabmc.edu.ORCID http://orcid.org/0000-0002-4676-7747
Christopher J StewartTranslational and Clinical Research Institute, Newcastle University, Newcastle, UK.
Gregory R YoungTranslational and Clinical Research Institute, Newcastle University, Newcastle, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEarly and increased exposure to human milk combined with minimal exposure to parenteral nutrition could reduce hospitalisation costs, improve postnatal growth, and influence the diversity of the gut microbiome.

methodsFaecal samples from very preterm infants randomised to receive either 60 to 80 ml/kg/day (intervention group) or 20 to 30 ml/kg/day (control group) of human milk within the first 36 h after birth were collected at approximately postnatal day 14. After trial completion, samples were analysed by 16S rRNA gene sequencing to determine early differences in the gut microbiome between the randomisation groups using adjusted models.

resultsWe analysed faecal samples from 95 infants with a median gestational age of 31 weeks (mean birthweight: 1487 g). In adjusted analyses, taxonomic richness and Shannon alpha diversity were not significantly higher in the intervention group. No significant differences in microbial diversity composition between samples (i.e., beta diversity) were found. Four distinctive de novo community clusters were identified during the trial, but they did not differ according to randomisation groups.

conclusionEarly and increased exposure to human milk shortly after birth does not appear to increase the richness and diversity of the gut microbiome by postnatal day 14 in very preterm infants.

trial registrationClinicalTrials.gov identifier: NCT04337710 IMPACT: In very preterm infants, early and increased exposure to human milk and its bioactive components did not alter gut microbiome richness or diversity by postnatal day 14. Randomisation strengthens microbiome analyses by limiting confounding in human milk feeding trials.

Indexed as

Gastrointestinal MicrobiomeInfant, Extremely PrematureMilk, HumanFecesFemaleGestational AgeHumansInfant, NewbornInfant, PrematureMaleParenteral NutritionRNA, Ribosomal, 16STime FactorsRNA, Ribosomal, 16S

Identifiers

PMID41034647
PMCPMC13221289

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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.