PEDIATRICS Vol. 117 No. 3 March 2006, pp. 985-986 (doi:10.1542/peds.2005-2937)
Randomized, Controlled Trial of Breastfeeding Versus Formula Feeding in Extremely Low Birth Weight Infants
Enrico Bertino, MDFrancesca Giuliani, MD
Paola Tonetto, MD
Claudio Fabris, MD
Department of Pediatrics
Neonatal Intensive Care Unit
Turin University
10133 Turin, Italy
Claudio Profeti, MD
Neonatal Intensive Care Unit
Meyer Pediatric Hospital
50100 Florence, Italy
Corrado Magnani, MD
Unit of Medical Statistics
Department of Medical Sciences
University of Eastern Piedmont et Novara
28100 Novara, Italy
Guido E. Moro, MD
Sertac Arslanoglu, MD
Center for Infant Nutrition
Division of Neonatology
Macedonio Melloni Hospital
20129 Milan, Italy
To the Editor.—
We read with great interest the recent article by Schanler et al,1 whose objective was to compare the incidence of late-onset sepsis, necrotizing enterocolitis (NEC), duration of hospitalization, and growth of extremely premature infants who were assigned randomly to receive either pasteurized donor milk (DM) or preterm formula (PF) if the supply of their own maternal milk (MM) was inadequate. They found that, as a substitute of MM, DM offered little short-term advantages over PF for feeding extremely premature infants. We feel that conclusions regarding the lack of advantages of DM over PF could be overstated.
First, we have some concerns about the authors' choice of presenting only the results of the intent-to-treat analysis; analysis according to the actual treatment should be presented when a large proportion of subjects are switched from one treatment to another. Because 21% of the infants in the DM group were switched to the PF group because of poor weight gain, whereas no infant in the PF group was switched to the DM group, we would expect to find greater, and even significant, differences between the 2 groups if compared on the basis of their actual feeding protocol. In addition, we would like to know if alternative strategies such as individualized human milk fortification2 were considered before shifting.
We found surprising the significant difference between the DM and PF groups in regard to maternal age and single head of household. We expected a similar distribution of these characteristics between the 2 groups after randomization. Because social characteristics are determinants of a child's health, it would be relevant to perform also a stratified analysis according to these variables.
Finally, the proposed sample size of the study was based on an expected incidence of late-onset sepsis and/or NEC, which was more than twice that observed in the study. Considering that infants in the PF group had an NEC incidence almost double that of those in the DM group, a significant difference could have been reached with a larger case series. It should be considered also that those in both the DM and PF groups received 
50% of their milk as MM; this fact could have reduced differences observed between the 2 groups. In a systematic review by McGuire and Anthony,3 who compared DM versus PF for preventing NEC in preterm infants, it is specified that the allocated milk feed should have formed the entire enteral intake, not a supplement to the expressed maternal breast milk.
We believe that additional studies comparing DM versus PF are required before definitive conclusions can be reached.
REFERENCES
1. Schanler RJ, Lau C, Hurst NM, O'Brian Smith E. Randomized trial of donor human milk versus preterm formula as substitutes for mothers' own milk in the feeling of extremely premature infants.
Pediatrics. 2005;116
:400
–406
2. 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[Web of Science][Medline]
3. McGuire W, Anthony MY. Donor human milk versus formula for preventing necrotising enterocolitis in preterm infants: systematic review.
Arch Dis Child Fetal Neonatal Ed. 2003;88
:F11
–F14
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: In Reply
- Richard J. Schanler, Chantal Lau, Nancy Hurst, and Elliott O'Brian Smith
Pediatrics 2006 117: 986-987.[Extract] [Full Text]
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