Published online March 1, 2006
PEDIATRICS Vol. 117 No. 3 March 2006, pp. 986-987 (doi:10.1542/peds.2005-3125)
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Randomized, Controlled Trial of Breastfeeding Versus Formula Feeding in Extremely Low Birth Weight Infants: In Reply

Richard J. Schanler, MD
Division of Neonatal-Perinatal Medicine
Schneider Children's Hospital at North Shore
North Shore University Hospital
Manhasset, NY 11030

Chantal Lau, PhD
Nancy Hurst, MSN
Elliott O'Brian Smith, PhD
Department of Pediatrics
Baylor College of Medicine
Houston, TX 77030

In Reply.—

We thank Bertino et al for their interest in our article. The following is our response to their comments.

  1. We wholeheartedly agree that additional studies are warranted to make definitive conclusions about the use of donor milk (DM) in extremely premature infants. We did find, however, that no short-term advantages were observed between DM and preterm formula (PF).
  2. In our study design (intention to treat), the groups were analyzed as they were assigned. Any protocol violators remained in the group to which they were assigned originally. However, secondary analyses of groups suggested that growth differences remained even after the protocol violators were removed. Re-analysis of the data omitting the protocol violators found the same relationships between DM and PF and when compared with maternal milk (MM).
  3. Individualized fortification, as published by Moro et al,1 was not practiced in our institution. However, the types and amounts of nutrient supplements given to the groups differed as indicated in the article. Although an individualized fortification strategy might be more useful, the logistics of providing such a detailed strategy would not be practical in our large NICUs.
  4. As expected in a randomized study, some variables may differ among groups. Sociodemographic variables were not deemed significant a priori to affect the differences in morbidity or growth. Nevertheless, as indicated in our article, the differences in the sociodemographic variables did not explain the differences, or lack of them, among groups.
  5. The proposed sample size was determined by studies published previously by our group.2 The rates of late-onset sepsis and/or necrotizing enterocolitis, a combined outcome, were lower than those in our original study. However, the combined rates were nearly identical between the DM and PF groups. Note that the rate of necrotizing enterocolitis was not a separate outcome.
  6. The design of this study was to mimic the method of feeding human milk in many US NICUs. We did not study the feeding of DM as a sole source of nutrition for our infants. The objective of our study was to study DM as a supplement if mother's milk was no longer available. Because most of our mothers begin to provide their milk, we believe that this approach represents the real NICU practice.

REFERENCES

  1. Moro GE, Minoli I, Ostrom M, et al. Fortification of human milk: evaluation of a novel fortification scheme and of a new fortifier. J Pediatr Gastroenterol Nutr. 1995;20 :162 –172[ISI][Medline]
  2. Schanler RJ, Shulman RJ, Lau C. Feeding strategies for premature infants: beneficial outcomes of feeding fortified human milk vs preterm formula. Pediatrics. 1999;103 :1150 –1157[Abstract/Free Full Text]
PEDIATRICS (ISSN 1098-4275). ©2006 by the American Academy of Pediatrics

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Randomized, Controlled Trial of Breastfeeding Versus Formula Feeding in Extremely Low Birth Weight Infants
Enrico Bertino, Francesca Giuliani, Paola Tonetto, Claudio Fabris, Claudio Profeti, Corrado Magnani, Guido E. Moro, and Sertac Arslanoglu
Pediatrics 2006 117: 985-986. [Extract] [Full Text]  




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Yersinia enterocolitica and...