Look in the archives. We have discussed this before. below is my letter to the editor, which should be in the Nov or Dec issue of Pediatrics in response to this study. (Was edited slightly.)
Letter to the Editor, Pediatrics:
RE: Schanler RJ, Lau C, Hurst NM, Smith EO. Randomized Trial of Donor Human Milk Versus Preterm Formula as Substitutes for Mothers' Own Milk in the Feeding of Extremely Premature Infants. Pediatrics 2005; 116:400-406
NEC = necrotizing enterocolitis
LOS = late onset sepsis
MM = mother's own milk group
DM = donor milk group
PF = preterm formula group
ROP = retinopathy of prematurity
As usual for Dr. Schanler, this study 1 is extremely well done with careful outcome definition and randomization, standardized feeding protocols, and sophisticated statistical analysis. The sample size was based on expected differences in NEC and LOS from a prior study 2. Fortunately for the infants, but unfortunately for the study, the incidence of NEC was almost 50% less than anticipated. Because the rates of NEC were much less than predicted, the sample sizes were inadequate to detect a significant difference if present, but both MM and DM groups had a 6 % incidence of NEC, while the PF group had 11 % (Table 2).
The paper does not specify which patients of their general NICU population eligible for the study were approached or excluded due to parents declining, death before day 4, etc. Also, while probably appropriate when looking at the outcomes of NEC and LOS, the study period started when babies were receiving ³ 50 mL/kg enteral feeds (mean of 18 days). These early feedings were presumably maternal milk, although it is not specified. Both the DM and PF groups received approximately 50 % of their enteral intake as their mother's own milk. There was no pure donor milk group. This significant amount of mothers' own milk, and possibly the first few feedings being mothers' own milk, may have washed out some of the differences in outcome.
Other interesting findings were the significant decrease in chronic lung disease with both MM and DM as compared with PF (Table 1) and the tendency (not statistically significant) for decreased ventilator days in both the MM and DM groups (Table 2). Less ROP was found in the MM group.
The growth parameters were also interesting with length increment (cm/wk) significantly shorter in the MM group vs. the DM or PF groups! There was no difference in head circumference increment between any of the 3 groups. Weight gain was slowest for the DM and fastest for the PF group as expected, but the authors do point out in the discussion that faster growth may not be better. They also point out that they did not study long-term outcomes such as IQ, blood pressure, obesity, etc.
There was a huge difference in skin-to-skin contact time between the MM group and the other 2 groups (Table 5). Skin-to-skin contact was highly correlated with the percentage of mother's own milk intake, and not correlated with any infection-related events. Interestingly, despite help from lactation consultants in the NICU, only 27 % of the mothers had enough milk to meet all their infant's needs.
I am interested in further results from this study, such as nutritional chemical markers (BUN, pre-albumin, alkaline phosphatase, Ca, Phos, etc.) and bone densities. Hopefully they were collected in the routine management of these patients. Perhaps they will be a separate paper.
On a purely editorial/presentation note, I find it curious that in each table the order is DM, PF, MM groups. This presentation tends to visually obscure the possible dose-response effect found in several variables, some significant, others only trends. For several variables, DM outcomes are between those of MM and PF.
The authors concluded that fortified donor human milk did not offer any short-term advantages over preterm formula, and indeed resulted in slower weight gain. They therefore recommend that every effort be made to support mothers in the NICU providing their own milk for their infants. They again confirmed the decrease in NEC, other infections and length of stay for infants fed their mothers' own milk. Another recent prospective observational study of 99.6% of all eligible ELBW infants (< 1000 g or < 28 weeks gestation) born in Norway in 1999 and 2000 demonstrated that very early feeding (96% fed by day 3 of life) with either mothers' own milk or donor milk significantly reduced the risk of LOS. 3
I think we can all agree that mother's own milk is the best, but I am not ready to give up on pasteurized donor milk. In a recent systematic review, preterm infants who were fed donor human milk had a 4 times reduced risk of NEC, compared with infants fed formula. 4 Current research into alternate methods of heat-treatment such as short time high temperature (STHT) may improve the survival of human milk factors better than current pasteurization methods. I believe additional studies, perhaps a multicenter trial in order to find enough infants who receive ONLY fortified donor milk, are needed.
Nancy E. Wight MD, FAAP, IBCLC
Attending Neonatologist,
Children's Hospital & Health Center, and
Sharp Mary Birch Hospital for Women
Medical Director, Sharp HealthCare Lactation Services
References:
Schanler RJ, Lau C, Hurst NM, Smith EO. Randomized Trial of Donor Human Milk Versus Preterm Formula as Substitutes for Mothers' Own Milk in the Feeding of Extremely Premature Infants. Pediatrics 2005; 116:400-406
Schanler RJ, Shulman RJ, Lau C. Feeding strategies for premature infants: beneficial outcomes of feeding fortified human milk versus preterm formula. Pediatrics 199; 103:1150-1157
Ronnestad A, Abrahamsen TG, Medbo S et al. Late-Onset Septicemia in a Norwegian National Cohort of Extremely Premature Infants Receiving Very Early Full Human Milk Feeding. Pediatrics 2005; 115(3):e269-276
McGuire W, Anthony MY. Donor human milk versus formula for preventing necrotizing enterocolitis in preterm infants: systematic review. Arch Dis Child Fetal Neonatal Ed. 2003; 88:F11-14
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