An Exclusively Human Milk-Based Diet Is Associated with a Lower Rate of Necrotizing Enterocolitis than a Diet of Human Milk and Bovine Milk-Based Products

Received 8 April 2009; received in revised form 16 September 2009; accepted 29 October 2009. published online 28 December 2009.

Objective

To evaluate the health benefits of an exclusively human milk–based diet compared with a diet of both human milk and bovine milk–based products in extremely premature infants.

Study design

Infants fed their own mothers' milk were randomized to 1 of 3 study groups. Groups HM100 and HM40 received pasteurized donor human milk–based human milk fortifier when the enteral intake was 100 and 40 mL/kg/d, respectively, and both groups received pasteurized donor human milk if no mother's milk was available. Group BOV received bovine milk–based human milk fortifier when the enteral intake was 100 mL/kg/d and preterm formula if no mother's milk was available. Outcomes included duration of parenteral nutrition, morbidity, and growth.

Results

The 3 groups (total n = 207 infants) had similar baseline demographic variables, duration of parenteral nutrition, rates of late-onset sepsis, and growth. The groups receiving an exclusively human milk diet had significantly lower rates of necrotizing enterocolitis (NEC; P = .02) and NEC requiring surgical intervention (P = .007).

Conclusions

For extremely premature infants, an exclusively human milk–based diet is associated with significantly lower rates of NEC and surgical NEC when compared with a mother's milk–based diet that also includes bovine milk–based products.

BOV, Bovine milk-based human milk fortifier, HMF, Human milk fortifier, HM40, Human milk-based HMF added once feeding volume reached 40 mL/kg/day, and pasteurized donor milk used if no mother's own milk available., HM100, Human milk-based HMF added once feeding volume reached 100 mL/kg/day and pasteurized donor milk used if no mother's own milk available., NEC, Necrotizing enterocolitis, PN, Parenteral nutrition, SD, Standard deviation

a Department of Pediatrics, University of Florida, Gainesville, FL

b Department of Pediatrics, Schneider Children's Hospital at North Shore, Manhasset, NY

c Albert Einstein College of Medicine, Bronx, NY

d Department of Pediatrics, University of Rochester, Golisano Children's Hospital at Strong, Rochester, NY

e Department of Pediatrics, University of California, San Diego Medical Center, San Diego, CA

f Children's Hospital and Research Center, Oakland, CA

g Prolacta Bioscience, Monrovia, CA

h Department of Pediatrics, Rush University Medical Center, Chicago, IL

i Department of Pediatrics, University of Utah Medical Center, Salt Lake City, UT

j Department of Pediatrics, University of Texas Health Science Center, San Antonio, TX

k Department of Pediatrics, Baylor College of Medicine, Houston, TX

l Department of Pediatrics, Duke University Medical Center, Durham, NC

m Pediatrics, Yale University School of Medicine, New Haven, CT

n Department of Pediatrics, Johns Hopkins School of Medicine, Baltimore, MD

o Department of Pediatrics, Innsbruck Medical University, Innsbruck, Austria

p MRC Child Nutrition Research Center, Institute of Child Health, London, United Kingdom

Reprint requests: Richard J. Schanler, MD, Division of Neonatal-Perinatal Medicine, North Shore University Hospital, 300 Community Dr, Manhasset, New York 11030.

S.S., R.J.S., J.H.K., A.L.P., R.T., U.K.-K., G.M.C., C.L.B., S.A., C.M.C., N.L., R.A.E., G.D., and E.A.C. received financial support from Prolacta Bioscience. The authors were responsible for the conduct of the study and collection of the data. M.L.L. and D.J.R. are employees of Prolacta Bioscience. A.L. is a paid Consultant of Prolacta Bioscience. P.M. received no support or payment. S.A., C.L.B., E.A.C., R.A.E., M.L.L., A.L., P.M., D.J.R., and R.J.S. were responsible for the design of the study. M.L.L. was responsible for the data analyses. R.J.S. wrote the draft of this manuscript. All of the authors were responsible for review and interpretation of the data and review of the manuscript.

Clinicaltrials.gov reg. # NCT00506584

PII: S0022-3476(09)01085-3

doi:10.1016/j.jpeds.2009.10.040

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