Summary of the characteristics of the seven included studies
Study Time period Design | Sample size | DBM group | Formula group | Study inclusion criteria | Baseline data in study population* | Feeding regimen | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Type o DBM (n) | Type of formula (n) | Gestation(weeks) | Birth weight(g) | Mean gestation (weeks) | Mean birth weight (g) | Route of delivery | Dose | Pre-allocation nutrition | When allocated feed started | Infants fed allocated diet until | Additional nourishment | Post diet regimen | ||
DBM, donor breast milk; IV, intravenous; N/A, not applicable as outcomes measured whilst on allocated diet; PTF, preterm formula; RCT, randomised controlled study; VLBW, very low birth weight. | ||||||||||||||
“Drip” milk: the milk that drips from one breast while the infant feeds at the other breast. | ||||||||||||||
*These were the characteristics of the study sample rather than specific inclusion criteria. | ||||||||||||||
†Lucas A and Lucas B refer to the Lucas study trial A (sole diet comparison) and trial B (supplementary diet comparison), respectively. | ||||||||||||||
‡Initially a quasi-RCT that became observational due to a change in selection criteria and population. | ||||||||||||||
Davies91972–1973 RCT | 68 | Term(34) | PTF(34) | 28–36* | 32.9 | 1954 | Not stated | 50 ml/kg increased to 200 ml/kg or until satisfied | Not stated | Not stated | 2 months old | If diet was not tolerated infants received 10%dextrose IV. All infants received vitamin and iron supplements | N/A | |
Raiha et al101972–1975RCT | 106 | Term(22) | Not stated(84) | 28–36 | ⩽2100 | 31–33 | 1680 | Smallest infants initially fed by gavage, others teat | Formula: 150 ml/kg.day DBM: 170 ml/kg/day | Not stated | Within 24 h of birth | 2400 g | DBM group were given vitamins A, D and C and ferrous sulphate | Not stated |
Schultz et al111980 RCT | 20 | “Mature”(10) | Not stated(10) | 30–37* | <2000* | 33.2 | 1698 | Not stated | Increased to 170 ml/kg/day by 1 week | None | Before 24 h (usually 6–12 h) | Not stated | Not stated | Not stated |
Gross121980–1982 RCT | 67 | Preterm(20) | PTF(46) | 27–33 | <1600 | 30.9 | 1322 | Gastric gavage | 24 ml/kg/day increased to 180 ml/kg/day | Not stated | Day 1–6 (mean day 3) | 1800 g | IV dextrose and electrolytes days 1–5 after birth, and 1 ml Poly Vi Sol from day 7; hyponatraemic babies received NaCl in their milk | All fed formula |
Term(21) | ||||||||||||||
Lucas A et al†13–221982–1984 RCT | 159 | “Mainly drip”(83) | PTF(76) | <1850 | 31.3 | 1401 | Nasogastric tube | Up to 200 ml/kg/24 h | In 3 centres all infants received DBM for first 24 h | Median 7 days | 2000 g or discharge | In total (trials A and B) 90/502 babies required initial parenteral nutrition | Not stated | |
Lucas B et al†13–221982–1984 RCT | 343 | “Mainly drip”(170) | PTF(173) | <1850 | 31.1 | 1388 | Nasogastric tube | Up to 200 ml/kg/24 h | In 3 centres all infants received DBM for first 24 h | Median 7 days | 2000 g or discharge | See above | Not stated | |
Cooper et al23Early 1980s Observational‡ | 39 | Preterm (24) | PTF(15) | <36 | 1200–1500 | 32.3 | 1359 | Nasogastric tube then bottle | Formula: 175 ml/kg/day DBM: 170–200 ml/kg/day | Not stated | When enteral feeding started | 1800 g | Daily vitamin D. | N/A |
Putet et al241984 Study design unclear | 12 | Not stated(6) | PTF(6) | “VLBW” | 30.2 | 1310 | Nasogastric gavage or teat | Formula: mean 157 ml/kg/day DBM: mean 168 ml/kg/day | Parenteral glucose and amino acid solution until oral feeding, all infants initially fed DBM within 24–48 hours until full diet had been reached | Study 1: once full oral feeding attained | Not stated | Not stated | N/A | |
Study 2: when infants reached the equivalentof 36 weeks |