Randomized Trial of Exclusive Human Milk versus Preterm Formula Diets in Extremely Premature Infants

Cristofalo, Elizabeth; Schanler, Richard J.; Blanco, Cynthia L.; Sullivan, Sandra; Trawoeger, Rudolf; Kiechl‐Kohlendorfer, Ursula; Dudell, Golde G.; Rechtman, David J.; Lee, Martin L.; Lucas, Alan; Abrams, Steven A.

doi:10.1016/j.jpeds.2013.07.011

Cited by 428 publications

(363 citation statements)

References 12 publications

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“…It is impossible to determine whether the lower rate of NEC seen in the human milk arm was due to the benefit of the human milk fortifier or to the benefit of giving human milk as opposed to bovine fortifier and formula. The Cristofalo study [34] is small and with a very high rate of NEC (21 %) in the bovine-fed group. While some believe that an all-human milk diet is a proven strategy to prevent/reduce NEC, a recent letter to the editor of Breastfeeding Medicine [37] suggests that an unequivocal case for the use of all-human milk fortifiers has not been determined and that a definitive and appropriately powered trial needs to be done.…”

Section: Donor Human Milk: Evidence and Research Needsmentioning

confidence: 94%

“…Two recent studies provide a contemporary look at exclusive human milk feeding compared to human milk supplemented with bovine antigen and the risk of NEC [7,34].…”

Section: Donor Human Milk: Evidence and Research Needsmentioning

confidence: 99%

“…Cristofalo et al [34] studied 53 infants with mean birth weight of approximately 1,000 g and compared rates of NEC in infants receiving exclusive human milk feedings or preterm bovine formula. They found that surgical NEC was statistically significantly greater, by 16 %, in the bovine formula-fed group compared to no cases in the exclusive human milk-fed infants.…”

Section: Donor Human Milk: Evidence and Research Needsmentioning

confidence: 99%

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Donor Human Milk: No Longer A Place For Formula in the Neonatal Intensive Care Unit?

Adamkin

Radmacher

2014

Curr Pediatr Rep

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Human milk is the best food for human infants, including those born preterm. Human milk feeding benefits the preterm infant by improving mental and motor development, decreasing the risk of necrotizing enterocolitis, sepsis, and retinopathy of prematurity during the postnatal period spent in the Neonatal Intensive Care Unit. In order to support the increased nutrient requirements of these infants, human milk must be fortified. In the absence of a mother's own milk, donor human milk is becoming a more commonly used replacement for bovine-based formula, especially in the tiniest patients. While donor human milk has been shown to convey many of the benefits of mother's own milk, it is generally lower in protein and calories than preterm milk and may require fortification in different proportions. This report discusses the evidence for donor human milk in the nutritional support of the preterm infant.

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Section: Donor Human Milk: Evidence and Research Needsmentioning

confidence: 94%

“…Two recent studies provide a contemporary look at exclusive human milk feeding compared to human milk supplemented with bovine antigen and the risk of NEC [7,34].…”

Section: Donor Human Milk: Evidence and Research Needsmentioning

confidence: 99%

Section: Donor Human Milk: Evidence and Research Needsmentioning

confidence: 99%

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Donor Human Milk: No Longer A Place For Formula in the Neonatal Intensive Care Unit?

Adamkin

Radmacher

2014

Curr Pediatr Rep

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“…Total parental nutrition leads to intestinal mucosal atrophy and increases the risk of NEC [15] and recent data suggests that early enteral feeding may reduce the risk of NEC [16,17]. Preterm infants given exclusive diets of preterm formula had a significantly greater duration of parenteral nutrition, and higher incidence of surgical NEC compared to infants who were administered human milk [18,19]. In preterm and low birth weight infants, feeding with formula milk compared with donor breast milk resulted in a higher rate of short-term growth but also a higher risk of developing NEC [20].…”

Section: Pathogenesismentioning

confidence: 99%

Necrotizing Enterocolitis (NEC): A Devastating Disease of Prematurity

Garg¹,

Garg²,

Lal³

2015

J Neonatal Biol

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Necrotizing Enterocolitis (NEC) is a common and devastating gastrointestinal emergency that primarily affects premature infants. The incidence of necrotizing enterocolitis is 6-10% among infants with birth weight less than 1500 grams. The mortality due to NEC has not improved significantly despite advances in neonatal care and better understanding of clinical and basic sciences. The pathogenesis of NEC is not well understood and several factors such as prematurity, abnormal colonization with pathogenic bacteria, feeding practices, blood transfusion and altered intestinal barrier function may be involved. The clinical presentation of NEC could be sudden and the treatment plan could vary with the stage and type of presentation. Further research is needed to better understand the pathophysiology of NEC and, biomarkers for prediction, prevention and treatment need to be developed. Further clinical trials are needed to determine prevention and treatment modalities for this devastating disease.

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“…[8][9][10] Prevention strategies include the use of human milk feedings, especially mother's own milk (MOM) 11,12 and, perhaps, pasteurized donor milk. 13 Human milk provides protection through a synergistic mix of nutritional, bioactive, and immunomodulatory effects in the VLBW infants. 14 A recent Cochrane Review of 24 randomized clinical trials indicated that probiotics reduced the incidence of severe NEC 15 ; however, support for this approach is not universal.…”

mentioning

confidence: 99%

Quality Improvement Initiative to Reduce the Necrotizing Enterocolitis Rate in Premature Infants

Talavera

Bixler²,

Cozzi³

et al. 2016

Pediatrics

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OBJECTIVE: To reduce the incidence of necrotizing enterocolitis (NEC) among very low birth weight (VLBW) infants admitted to 8 intensive care nurseries from a 2010 baseline of 8.0% to <4.0% by 2012 and sustain for 6 months using quality improvement (QI) methodology. METHODS: A multidisciplinary NEC QI team used the Vermont Oxford Network definition of NEC and the Institute for Healthcare Improvement model. The specific aims were evidenced based and included (1) standardized early human milk feedings, (2) conservative feeding guidelines during blood transfusions and indomethacin treatment, and (3) restriction of ranitidine use in VLBW infants. Inclusion criteria included VLBW infants admitted within the study period without NEC. Exclusion criteria included established NEC or spontaneous intestinal perforation unrelated to NEC. The incidence of NEC and NEC-related surgery were tracked using statistical process control methodology. RESULTS: The baseline NEC rate in 2010 was 8% (27 NEC cases in 335 VLBW infants). After initiation of early human-milk feeding and conservative feeds during blood transfusions guidelines in November 2011, only 3.1% (19 of 606 VLBW infants) had developed NEC through December 2013 (P = .001). Special cause variation was noted in June 2012 establishing a new centerline at 3.1%. NEC-related mortality decreased from a 2010 baseline mean of 2.7% to a new baseline mean of 0.9% from January 2011 to December 2013. CONCLUSIONS: Implementation of QI initiatives decreased the NEC rate from 8.0% to <4.0%. Early human milk feedings and conservative feeding during blood transfusion policies appear to have significant impact on NEC reduction.

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Randomized Trial of Exclusive Human Milk versus Preterm Formula Diets in Extremely Premature Infants

Cited by 428 publications

References 12 publications

Donor Human Milk: No Longer A Place For Formula in the Neonatal Intensive Care Unit?

Donor Human Milk: No Longer A Place For Formula in the Neonatal Intensive Care Unit?

Necrotizing Enterocolitis (NEC): A Devastating Disease of Prematurity

Quality Improvement Initiative to Reduce the Necrotizing Enterocolitis Rate in Premature Infants

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