Evidence map›Paper›PMID 38724605›Full record

Trial reportJournal of perinatology : official journal of the California Perinatal Association2024

Immediate fortification of human milk with a bovine milk-derived human milk fortifier in very low birth weight infants: a randomized clinical trial.

Zanna Wynter, Jane Anne Gorham, Amy B Thompson, Cynthia Mundy, Jennifer L Waller, Brian K Stansfield

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of perinatology : official journal of the California Perinatal Association, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05228535 (Early Fortification of Human Milk for Very Low Birth Weight Infants and Effects on Growth Velocity), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT05228535 naunknown statusnot on this map

Early Fortification of Human Milk for Very Low Birth Weight Infants and Effects on Growth Velocity

TypeinterventionalSponsorAugusta UniversityRan2022 to 2023Enrolled50ConditionsPreterm BirthArmsHuman milk fortifier
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. 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

6 authors.

Zanna WynterDepartment of Pediatrics, Augusta University, Augusta, GA, USA.
Jane Anne GorhamDepartment of Pediatrics, Augusta University, Augusta, GA, USA.ORCID 0009-0001-0983-2335
Amy B ThompsonDepartment of Pediatrics, Augusta University, Augusta, GA, USA.
Cynthia MundyDepartment of Pediatrics, Augusta University, Augusta, GA, USA.
Jennifer L WallerDepartment of Family and Community Medicine, Augusta University, Augusta, GA, USA.ORCID 0000-0003-4066-4541
Brian K StansfieldDepartment of Pediatrics, Augusta University, Augusta, GA, USA. BSTANSFIELD@augusta.edu.ORCID 0000-0002-1105-8895

Funding

Inflammation and retinopathy of prematurityR01EY029318 · NEI · AUGUSTA UNIVERSITY · PI STANSFIELD, BRIAN KEVIN · 2019 to 2023
$2.2M
NEI NIH HHS R01 EY029318
6 · The paper itself

Abstract

objectiveDouble-blind randomized control trial of early addition of a bovine milk-derived human milk fortifier (HMF) in very low birth weight (VLBW) infants (NCT05228535).

methodsVLBW infants were randomized to receive bovine milk-derived HMF with first feedings or delayed fortification at 80 ml/kg/day. Anthropometrics were assessed weekly through 36 weeks postmenstrual age (PMA). Unadjusted and adjusted (race, gender, gestational age, and birth weight) differences between study arms were examined using two-sample t-test and ANCOVA, respectively.

resultsFifty-two VLBW infants (57% female, 60% Black) were enrolled. Baseline demographics did not differ between groups. Weight velocity at DOL 28 did not differ between study arms. Secondary outcomes including NPO occurrence, incidence of metabolic acidosis, NEC, retinopathy, or late-onset sepsis did not differ between groups.

conclusionImmediate fortification of enteral feedings with a bovine milk-derived HMF appears safe and well-tolerated although no clear growth benefit could be established.

Indexed as

Food, FortifiedInfant, Very Low Birth WeightMilkMilk, HumanAnimalsBirth WeightCattleDouble-Blind MethodEnteral NutritionFemaleGestational AgeHumansInfant, NewbornInfant Nutritional Physiological PhenomenaInfant, PrematureMale

Identifiers

PMID38724605
PMCPMC11518976

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.