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

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Objective: Uncertainty 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. Methods: In 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). Results: Of 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. Conclusions: Randomisation 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.

Location
Deutsche Nationalbibliothek Frankfurt am Main
Extent
Online-Ressource
Language
Englisch

Bibliographic citation
Preterm Formula, Fortified or Unfortified Human Milk for Very Preterm Infants, the PREMFOOD Study: A Parallel Randomised Feasibility Trial ; volume:121 ; number:2 ; year:2024 ; pages:222-232 ; extent:11
Neonatology ; 121, Heft 2 (2024), 222-232 (gesamt 11)

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

DOI
10.1159/000535498
URN
urn:nbn:de:101:1-2024041101181039821302
Rights
Open Access; Der Zugriff auf das Objekt ist unbeschränkt möglich.
Last update
14.08.2025, 10:59 AM CEST

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Associated

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

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