Evidence map›Paper›PMID 37551512›Full record

Trial reportPediatrics2023

Early Human Milk Fortification in Infants Born Extremely Preterm: A Randomized Trial.

Ariel A Salas, Emily Gunawan, Kelly Nguyen, Audrey Reeves, Victoria Argent, Amber Finck, Waldemar A Carlo

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pediatrics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04325308 (Early Life Protein-enriched Human Milk Diets to Increase Lean Body Mass Accretion and Diversity of the Gut Microbiome in Extremely Preterm Infants), which is not on this map. Cited by 29 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 2 pooled it
6.0field-weighted citation impact, top 3% 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.

NCT04325308 naactive not recruitingnot on this map

Early Life Protein-enriched Human Milk Diets to Increase Lean Body Mass Accretion and Diversity of the Gut Microbiome in Extremely Preterm Infants: a Randomized Trial

TypeinterventionalSponsorUniversity of Alabama at BirminghamRan2020 to 2027Enrolled150ConditionsPrematurity, Extreme, Feeding Disorder Neonatal, Breast Milk ExpressionArmsProtein-enriched human milk diet, Usual human milk diet
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 37 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Ariel A SalasDepartment of Pediatrics, Heersink School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.
Emily GunawanDepartment of Pediatrics, Heersink School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.
Kelly NguyenDepartment of Pediatrics, Heersink School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.
Audrey ReevesDepartment of Pediatrics, Heersink School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.
Victoria ArgentDepartment of Pediatrics, Heersink School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.
Amber FinckDepartment of Pediatrics, Heersink School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.
Waldemar A CarloDepartment of Pediatrics, Heersink School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.
University of Alabama at Birmingham · US

Funding

Early life protein-enriched human milk diets to increase lean body mass accretion and diversity of the gut microbiome in extremely preterm infants: a randomized trialK23HD102554 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI SALAS, ARIEL · 2020 to 2024
$774k
NICHD NIH HHS K23 HD102554
6 · The paper itself

Abstract

objectivesEnteral nutrition with unfortified human milk during the first 2 postnatal weeks often leads to cumulative protein and energy deficits among preterm infants. Fortified human milk administered soon after birth could increase fat-free mass (FFM) and improve growth in these infants.

methodsThis was a masked, randomized trial. Starting on feeding day 2, extremely preterm infants 28 weeks or younger fed maternal or donor milk were randomized to receive either a diet fortified with a human-based product (intervention group) or a standard, unfortified diet (control group). This practice continued until the feeding day when a standard bovine-based fortifier was ordered. Caregivers were masked. The primary outcome was FFM-for-age z score at 36 weeks of postmenstrual age (PMA).

resultsA total of 150 infants were randomized between 2020 and 2022. The mean birth weight was 795±250 g, and the median gestational age was 26 weeks. Eleven infants died during the observation period. The primary outcome was assessed in 105 infants (70%). FFM-for-age z scores did not differ between groups. Length gain velocities from birth to 36 weeks PMA were higher in the intervention group. Declines in head circumference-for-age z score from birth to 36 weeks' PMA were less pronounced in the intervention group.

conclusionsIn infants born extremely preterm, human milk diets fortified soon after birth do not increase FFM accretion at 36 weeks' PMA, but they may increase length gain velocity and reduce declines in head circumference-for-age z scores from birth to 36 weeks' PMA.

Indexed as

Infant, Extremely PrematureMilk, HumanAnimalsBirth WeightCattleFemaleFood, FortifiedGestational AgeHumansInfantInfant, NewbornInfant, Very Low Birth Weight

Identifiers

PMID37551512
PMCPMC10471508
OpenAlexW4385647711

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.