Evidence for the use of donor milk

Published randomized control trials of human donor milk:

Author, Year Title, Journal Country Infants Intervention Results
O’Connor, 2016 Effect of Supplemental Donor Human Milk Compared With Preterm Formula on Neurodevelopment of Very Low-Birth-Weight Infants at 18 Months: A Randomized Clinical Trial.

 

JAMA. 316(18):1897-1905.

Canada <1500g Preterm formula

vs

Donor milk

for 90 days

Significant reduction in NEC in donor milk fed infants (1.7% vs 6.6%)

No difference in morbidity/mortality index

No difference in neurodevelopment

Corpelejin,

2016

Effect of Donor Milk on Severe Infections and Mortality in Very Low-Birth-Weight Infants: The Early Nutrition Study Randomized Clinical Trial.

 

JAMA Pediatr. 170(7):654-661.

Netherlands <1500g Preterm formula

vs

Donor milk

for 10 days

No difference in NEC or sepsis
Hair,       2014 Randomized trial of human milk cream as a supplement to standard fortification of an exclusive human milk-based diet in infants 750-1250 g birth weight.

 

J Pediatr. 165(5):915-920.

USA <1250 g Human cream Faster weight and length growth but no change in head circumference for infants supplemented with human cream
Cristofalo, 2013 Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants.

 

J Pediatr. 163(6):1592-1595 e1591.

USA <1250g Preterm formula

vs

Donor milk

(no mother’s milk)

Significant reduction in NEC in donor milk fed infants

Fewer days of parenteral nutrition in donor milk fed infants

Sullivan, 2010 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.

 

J Pediatr. 156(4):562-567 e561.

USA, Austria <1250g Donor milk and Human milk based fortifier

vs

Preterm formula and Bovine fortifier

Significant reduction in NEC in human milk fortifier group
Schanler, 2005 Randomized trial of donor human milk versus preterm formula as substitutes for mothers’ own milk in the feeding of extremely premature infants.

 

Pediatrics. 116(2):400-406.

USA <30 weeks Preterm formula

vs

Donor milk

No difference in infection related events (sepsis, NEC, meningitis, UTI)
Morley,    2000 Randomized diet in the neonatal period and growth performance until 7.5-8 y of age in preterm children.

 

Am J Clin Nutr. 71(3):822-828.

UK <1850g Preterm formula

vs

Donor milk

No difference in growth at 7.5-8 years
Lucas,     1984, 1989, 1990, 1994 Multicentre trial on feeding low birthweight infants: effects of diet on early growth.

 

Arch Dis Child. 59(8):722-730.

Arch Dis Child. 64(11):1570-1578.

Lancet. 336(8730):1519-1523.

Arch Dis Child Fetal Neonatal Ed. 70(2):F141-146.

UK <1850g Preterm formula

vs

Donor milk

Significant reduction in NEC in donor milk fed infants

No difference in 18 month neurodevelopment

Slower growth in donor milk fed infants (no fortifier used)

Tyson,     1983 Growth, metabolic response, and development in very-low-birth-weight infants fed banked human milk or enriched formula. I. Neonatal findings.

 

J Pediatr. 103(1):95-104.

USA <1500g Preterm formula

vs

Donor milk

Slower growth in donor milk fed infants (no fortifier used)

No clinically significant differences in biochemical indices between groups

Gross,              1983 Growth and biochemical response of preterm infants fed human milk or modified infant formula.

 

N Engl J Med. 308(5):237-241.

USA <1600g Term formula

vs

Donor milk

Slower growth in term donor milk fed infants compared to preterm donor milk or term formula
Svenningsen, 1982 Growth in relation to protein intake of low birth weight infants.

 

Early Hum Dev. 6(1):47-58.

Sweden <2000g Preterm formula

vs

Donor milk

No difference in early growth

No difference in neurodevelopment

Schultz,

1980

The metabolic consequences of human milk and formula feeding in premature infants.

 

Acta Paediatr Scand. 69(5):647-652.

Hungary <2000g Preterm formula

vs

Donor milk

Lower glucose in infants fed preterm formula along with higher BUN and metabolic acidosis
Davies,

1977

Adequacy of expressed breast milk for early growth of preterm infants.

 

Arch Dis Child. 52(4):296-301.

Wales <36 weeks Preterm formula

vs

Donor milk

Lower birth weight group showed slower growth for first month in donor milk fed infants
Raiha,

1976

Milk protein quantity and quality in low-birthweight infants: I. Metabolic responses and effects on growth.

 

Pediatrics. 57(5):659-684.

Finland <2100g Preterm formula

vs

Donor milk

No difference in growth