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

Autor:	Mills L; Chelsea and Westminster NHS Foundation Trust, London, UK.; Section of Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK., Chappell KE; Section of Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK., Emsley R; Chelsea and Westminster NHS Foundation Trust, London, UK.; Section of Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK., Alavi A; Imperial College Healthcare NHS Trust, London, UK., Andrzejewska I; Chelsea and Westminster NHS Foundation Trust, London, UK.; Section of Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK., Santhakumaran S; Section of Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK., Nicholl R; London Northwest University Healthcare NHS Trust, London, UK., Chang J; Croydon Health Services NHS Trust, London, UK., Uthaya S; Chelsea and Westminster NHS Foundation Trust, London, UK.; Section of Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK., Modi N; Chelsea and Westminster NHS Foundation Trust, London, UK.; Section of Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.
Jazyk:	angličtina
Zdroj:	Neonatology [Neonatology] 2024; Vol. 121 (2), pp. 222-232. Date of Electronic Publication: 2023 Dec 13.
DOI:	10.1159/000535498
Abstrakt:	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. (© 2023 The Author(s). Published by S. Karger AG, Basel.)
Databáze:	MEDLINE
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