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Lactation Information and Discussion <[log in to unmask]>
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Sun, 4 Sep 2005 18:29:33 EDT
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This is what I sent.
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
President, Academy of Breastfeeding Medicine
 
 
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

Nancy
Nancy E. Wight MD, IBCLC, FABM, FAAP
Neonatologist, Sharp Mary Birch Hospital for Women and Children's Hospital
Medical Director, Sharp HealthCare Lactation Services
San Diego, CA
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