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 |