Characteristics of included studies: participants, intervention, and outcome
| Trial (year published) | Participants | Setting | Interventions | Outcomes (n/N) | Notes |
|---|---|---|---|---|---|
| Gross (1983)12 | 67 preterm infants (27–33 weeks gestation). Birth weight <1600 g. Excluded if “congenital anomaly or major disease, or if growth restricted.” | Department of Pediatrics, Duke University, USA. 1980–82. | Donor human, term (N=20) or preterm (N=21) milk versus standard-calorie formula milk (N=26). Feeds assigned until infant weight reached 1800 g | NEC (confirmed): Donor human milk: 1/41 Formula milk: 6/26 | NEC was a withdrawal criterion not primary end-point of the study. |
| Lucas (1990)3 | 159 infants, birth weight <1850 g. Infants with congenital abnormalities excluded. | Neonatal units in Anglia, UK. Early 1980s | Donor (mainly drip) human milk (N=83) versus calorie-enriched formula as sole diet (N=76) | NEC (suspected and confirmed): Donor human milk: 3/83 Formula milk: 6/76 NEC (confirmed only): Donor human milk: 1/83 Formula milk: 4/76 | Parallel study assessed outcomes in infants who received donor human milk or formula as a supplement to the mother’s expressed breast milk. |
| Svenningsen (1982)10 | 36 low birth weight infants. | Department of Paediatrics, University Hospital, Lund, Sweden. Early 1980s | Donor human milk (N=6) versus standard-calorie formula milk (N=30) | NEC (confirmed): Donor human milk: 0/6 Formula milk: 0/30 | Feeds randomly allocated in second week of life. |
| Tyson (1983)11 | 81 very low birth weight infants, excluding infants with “any significant illness” or those who required ventilatory support at day 10 of life | Department of Pediatrics, University of Texas, Dallas, USA. Early 1980s | Donor human milk (N=37) versus calorie-enriched formula (N=44). | NEC (suspected and confirmed): Donor human milk: 0/37 Formula milk: 2/44 NEC (confirmed only): Donor human milk: 0/37 Formula milk: 1/44 | NEC reported as withdrawal criterion rather than outcome. Feeds allocated on the tenth day of life and continued until the infant reached a weight of 2000 g |