Evidence map›Paper›PMID 38091960›Full record

Trial reportNeonatology2024

Preterm Formula, Fortified or Unfortified Human Milk for Very Preterm Infants, the PREMFOOD Study: A Parallel Randomised Feasibility Trial.

Luke Mills, Karyn E Chappell, Robby Emsley, Afshin Alavi, Izabela Andrzejewska, Shalini Santhakumaran, Richard Nicholl, John Chang, Sabita Uthaya, Neena Modi

Open access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neonatology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
1.5field-weighted citation impact, top 19% 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

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Formula protein versus human milk protein and the effects on growth in preterm born infants.Current opinion in clinical nutrition and metabolic care · 2025
    Review
  7. 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

10 authors at 4 institutions in 1 country.

Luke MillsChelsea and Westminster NHS Foundation Trust, London, UK.
Karyn E ChappellSection of Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.
Robby EmsleyChelsea and Westminster NHS Foundation Trust, London, UK.
Afshin AlaviImperial College Healthcare NHS Trust, London, UK.
Izabela AndrzejewskaChelsea and Westminster NHS Foundation Trust, London, UK.
Shalini SanthakumaranSection of Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.
Richard NichollLondon Northwest University Healthcare NHS Trust, London, UK.
John ChangCroydon Health Services NHS Trust, London, UK.
Sabita UthayaChelsea and Westminster NHS Foundation Trust, London, UK.
Neena ModiChelsea and Westminster NHS Foundation Trust, London, UK.
Imperial College London · GBChelsea and Westminster Hospital NHS Foundation Trust · GBCroydon Health Services NHS Trust · GBImperial College Healthcare NHS Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveUncertainty exists regarding optimal supplemental diet for very preterm infants if the mother's own milk (MM) is insufficient. We evaluated feasibility for a randomised controlled trial (RCT) powered to detect important differences in health outcomes.

methodsIn this open, parallel, feasibility trial, we randomised infants 25+0-31+6 weeks of gestation by opt-out consent to one of three diets: unfortified human milk (UHM) (unfortified MM and/or unfortified pasteurised human donor milk (DM) supplement), fortified human milk (FHM) (fortified MM and/or fortified DM supplement), and unfortified MM and/or preterm formula (PTF) supplement from birth to 35+0 weeks post menstrual age. Feasibility outcomes included opt-outs, adherence rates, and slow growth safety criteria. We also obtained anthropometry, and magnetic resonance imaging body composition data at term and term plus 6 weeks (opt-in consent).

resultsOf 35 infants randomised to UHM, 34 to FHM, and 34 to PTF groups, 21, 19, and 24 infants completed imaging at term, respectively. Study entry opt-out rate was 38%; 6% of parents subsequently withdrew from feeding intervention. Two infants met predefined slow weight gain thresholds. There were no significant between-group differences in term total adipose tissue volume (mean [SD]: UHM: 0.870 L [0.35 L]; FHM: 0.889 L [0.31 L]; PTF: 0.809 L [0.25 L], p = 0.66), nor in any other body composition measure or anthropometry at either timepoint.

conclusionsRandomisation to UHM, FHM, and PTF diets by opt-out consent was acceptable to parents and clinical teams, associated with safe growth profiles and no significant differences in body composition. Our data provide justification to proceed to a larger RCT.

Indexed as

Infant, PrematureMilk, HumanFeasibility StudiesHumansInfantInfant FormulaInfant, NewbornInfant, Very Low Birth WeightWeight GainClinical outcomesClinical trialNutrition

Identifiers

PMID38091960
PMCPMC10994632
OpenAlexW4389660756

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

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.