Tolerance of preterm formula versus pasteurized donor human milk in very preterm infants: A randomized non-inferiority trial

Luca Maggio, Giovanni Vento, Simonetta Costa, Francesco Cota

Risultato della ricerca: Contributo in rivistaArticolo in rivistapeer review

7 Citazioni (Scopus)


Background: Human milk (HM) is the best feeding for premature infants. When own mother's milk (OMM) is insufficient or unavailable, pasteurized donor human milk (PDHM) and preterm formula (PF) are the alternative nutritional sources, but the benefits of donor milk over formula are not defined. This study aimed to assess whether, in the absence of OMM, the PF could guarantee a feeding tolerance not inferior to that seen with the use of PDHM during the first two weeks of life of very preterm infants. Methods: Infants with gestational age (GA) of ≤32 weeks who started enteral feeding within the first 7 days of life were randomized to receive PDHM or PF as a supplement to the OMM insufficient or unavailable. The primary outcome was the day of life when full enteral feeding (FEF) of 150 mL/Kg/d was achieved. Results: Seventy infants were randomized, 35 in the PF group (GA 30.2 ± 1.7 weeks; BW 1342 ± 275 g), 35 in the PDHM group (GA 30 ± 1.9 weeks; BW 1365 ± 332 g). The time to achieve FEF was the same for infants fed with PF and for infants fed with PDHM (12.3 ± 7.0 days vs 12.8 ± 6.5). Conclusions: This trial shows that PF could be a valid alternative for the early feeding of very preterm infants when OMM is insufficient or unavailable. Trial registration: UMIN000013922. Date of formal registration: December 31, 2014.
Lingua originaleEnglish
pagine (da-a)96-N/A
Numero di pagine6
Stato di pubblicazionePubblicato - 2018


  • Child Development
  • Feeding tolerance
  • Female
  • Follow-Up Studies
  • Gestational Age
  • Humans
  • Infant Formula
  • Infant Nutritional Physiological Phenomena
  • Infant, Extremely Premature
  • Infant, Newborn
  • Infant, Premature
  • Male
  • Milk, Human
  • Pasteurization
  • Pasteurized donor human milk
  • Patient Selection
  • Pediatrics, Perinatology and Child Health
  • Preterm formula
  • Risk Assessment
  • Very preterm infant
  • Weight Gain


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