Randomized trial of donor human milk versus preterm formula as substitutes for mothers’ own milk in feeding of extremely premature infants

Baylor College of Medicine, Houston, Texas, United States
PEDIATRICS (Impact Factor: 5.47). 09/2005; 116(2):400-6. DOI: 10.1542/peds.2004-1974
Source: PubMed


Compared with preterm formula (PF), mother's milk (MM) is associated with lower rates of late-onset sepsis (LOS) and necrotizing enterocolitis (NEC) among premature infants. Because not all mothers of premature infants produce sufficient milk to supply their infants throughout hospitalization, we reasoned that pasteurized donor human milk (DM) would be a suitable alternative.
Extremely premature infants (<30 weeks of gestation) whose mothers intended to breastfeed were assigned randomly to receive either pasteurized DM or PF if the supply of their own MM became insufficient during the study (birth to 90 days of age or hospital discharge). Infection-related events (LOS, NEC, meningitis, presumed sepsis, or urinary tract infection) that occurred after the attainment of a milk intake of 50 mL/kg, dietary intake, growth, skin-to-skin contact, and duration of hospital stay were compared. The primary analysis compared groups DM and PF on an intent-to-treat basis. If no differences were noted, then these groups were combined and compared with the reference group, group MM. If differences were noted, then the subsequent analyses compared each group with group MM.
Of 243 infants, 70 (29%) received only MM; group DM included 81 infants and group PF included 92 infants. Because of poor weight gain, 17 infants (21%), all in group DM, were switched to PF. There were no differences in birth weight, gestational age, multiple births, and age at attainment of feeding of 50 mL/kg among groups. There were no differences between group DM and group PF in LOS and/or NEC, other infection-related events, hospital stay, or number of deaths. Group DM received a greater intake of milk and more nutritional supplements but had a slower rate of weight gain, compared with group PF. Compared with groups DM and PF, group MM had fewer episodes of LOS and/or NEC and total infection-related events and a shorter duration of hospital stay. Group MM also had fewer Gram-negative organisms isolated from blood cultures than did the other groups.
In this randomized, blinded trial of feeding of extremely premature infants, we found that, as a substitute for MM, DM offered little observed short-term advantage over PF for feeding extremely premature infants. Advantages to an exclusive diet of MM were observed in terms of fewer infection-related events and shorter hospital stays.

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Available from: Nancy M. Hurst, Jul 31, 2014
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    • "These infants benefit from donor breastmilk (DBM) when their own mothers are unable to provide sufficient volumes of breastmilk. One of the main reasons for using DBM for this cohort of infants is to prevent the severe, costly, and sometimes fatal gastrointestinal disease called necrotizing enterocolitis, the prevalence of which is drastically reduced when preterm infants are fed a diet of breastmilk rather than formula 2 (Schanler et al. 2005). "

    Ethnographies of Breastfeeding: Cultural Contexts and Confrontations, Edited by Tanya Cassidy and Abdullahi El-Tom, 12/2014: chapter Breastmilk Donation as Care Work; Bloomsbury., ISBN: 9781472569264
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    • "Feeding practices have also since changed to include preferential use of mother’s own milk along with nutrient fortification of human milk to promote adequate growth. There was only one RCT [30] in the Cochrane review that was reflective of current clinical practice which includes much smaller babies, preferential use of mother’s own milk and nutrient fortification. This study however did not look at long-term neurocognitive outcomes. "
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    ABSTRACT: Background: Provision of mother's own milk is the optimal way to feed infants, including very low birth weight infants (VLBW, <1500 g). Importantly for VLBW infants, who are at elevated risk of neurologic sequelae, mother's own milk has been shown to enhance neurocognitive development. Unfortunately, the majority of mothers of VLBW infants are unable to provide an adequate supply of milk and thus supplementation with formula or donor milk is necessary. Given the association between mother's own milk and neurodevelopment, it is important to ascertain whether provision of human donor milk as a supplement may yield superior neurodevelopmental outcomes compared to formula.Our primary hypothesis is that VLBW infants fed pasteurized donor milk compared to preterm formula as a supplement to mother's own milk for 90 days or until hospital discharge, whichever comes first, will have an improved cognitive outcome as measured at 18 months corrected age on the Bayley Scales of Infant Development, 3(rd) ed. Secondary hypotheses are that the use of pasteurized donor milk will: (1) reduce a composite of death and serious morbidity; (2) support growth; and (3) improve language and motor development. Exploratory research questions include: Will use of pasteurized donor milk: (1) influence feeding tolerance and nutrient intake (2) have an acceptable cost effectiveness from a comprehensive societal perspective? Methods/design: DoMINO is a multi-centre, intent-to-treat, double blinded, randomized control trial. VLBW infants (n = 363) were randomized within four days of birth to either (1) pasteurized donor milk or (2) preterm formula whenever mother's own milk was unavailable. Study recruitment began in October 2010 and was completed in December 2012. The 90 day feeding intervention is complete and long-term follow-up is underway. Discussion: Preterm birth and its complications are a leading cause long-term morbidity among Canadian children. Strategies to mitigate this risk are urgently required. As mother's own milk has been shown to improve neurodevelopment, it is essential to ascertain whether pasteurized donor milk will confer the same advantage over formula without undue risks and at acceptable costs. Knowledge translation from this trial will be pivotal in setting donor milk policy in Canada and beyond. Trial registration: ISRCTN35317141; Registered 10 August 2010.
    BMC Pediatrics 05/2014; 14(1):123. DOI:10.1186/1471-2431-14-123 · 1.93 Impact Factor
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    • "Studies have shown a decreased incidence of inflammation and local and systemic infections such as urinary tract infections, invasive fungal infections (IFI), late onset sepsis (LOS) and necrotizing enterocolitis (NEC) although some studies particularly those of NEC are inconclusive due to the multifactorial nature of the disease. One study, however, has shown the incidence of late onset sepsis (LOS) in very low birth weight (VLBW) infants was greater for infants fed with artificial formula (26%; n=88) and holder pasteurized donor human milk (23%; n=78) compared to mothers’ own milk (16%; n=70) [55]. The incidence of LOS in the donor human milk group is likely due to the inclusion of 21% of the infants that also received preterm formula due to poor weight gain and this aberration was not accounted for statistically. "
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    ABSTRACT: Human milk possesses bacteriostatic properties, largely due to the presence of immunological proteins. Heat treatments such as Holder pasteurization reduce the concentration of immunological proteins in human milk and consequently increase the bacterial growth rate. This study investigated the bacterial growth rate and the immunological protein concentration of ultraviolet (UV-C) irradiated, Holder pasteurized and untreated human milk. Samples (n=10) of untreated, Holder pasteurized and UV-C irradiated human milk were inoculated with E. coli and S. aureus and the growth rate over 2 hours incubation time at 37°C was observed. Additionally, the concentration of sIgA, lactoferrin and lysozyme of untreated and treated human milk was analyzed. The bacterial growth rate of untreated and UV-C irradiated human milk was not significantly different. The bacterial growth rate of Holder pasteurized human milk was double compared to untreated human milk (p<0.001). The retention of sIgA, lactoferrin and lysozyme after UV-C irradiation was 89%, 87%, and 75% respectively, which were higher than Holder treated with 49%, 9%, and 41% respectively. UV-C irradiation of human milk preserves significantly higher levels of immunological proteins than Holder pasteurization, resulting in bacteriostatic properties similar to those of untreated human milk.
    PLoS ONE 12/2013; 8(12):e85867. DOI:10.1371/journal.pone.0085867 · 3.23 Impact Factor
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