| Methods |
Randomised controlled trial |
| Participants |
343 infants of birth weight < 1850 g. Stratified by birth weight < 1200 g and 1201 g to 1850 g.
Infants with congenital abnormalities excluded. Infants with intrauterine growth restriction not excluded
Study undertaken in the early 1980s in neonatal units in the Anglia region of the UK |
| Interventions |
Preterm formula milk (N = 173) versus banked donor breast milk (N = 170) as a supplement to the mother's own breast milk |
| Outcomes |
Short‐term outcomes: time to regain birth weight (132 infants). Rates of change in weight (115 infants), crown‐heel length (45 infants) and head circumference (97 infants) from the point of regained birth weight until discharge from the neonatal unit or reaching a weight of 2000 g
Incidence of NEC ‐ suspected and confirmed reported on complete cohort of 343 infants
Longer‐term outcomes:
Validated neurological assessment, at 18 months, in 278 (88%) of surviving infants
Bayley Mental Development Index and Psychomotor Development Index at 18 months, corrected for preterm gestation, in 273 (96%) of surviving infants suitable for the assessment
Growth performance in surviving infants (weight, length and head circumference) at 9 months (259 infants), 18 months (302 infants) and 7.5 years to 8 years (290 infants) post‐term |
| Notes |
The first "interim" report provided data on short‐term growth outcomes in a predefined subset of the total cohort recruited.
Developmental assessments (Bayley Psychomotor and Mental Development Indices) at 18 months post‐term were reported for 273 of 343 children originally enrolled in the study. 29 children had died and 12 had been lost to follow‐up. 24 surviving children had cerebral palsy affecting fine motor skills and these children were not assessed. A further 5 children were not assessed due to severe visual or hearing impairment or because follow‐up data were obtained by telephone for geographical reasons. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not stated |
| Allocation concealment (selection bias) |
Low risk |
Sealed, numbered envelopes |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
No information given |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
100% assessment of in‐hospital outcomes and > 80% follow‐up for long‐term outcomes except for cognitive outcomes (verbal and performance intelligence quotient) which were assessed in about 20% of participants at ages 8 and 16 years) |
| Selective reporting (reporting bias) |
Unclear risk |
Protocol not available |
| Other bias |
Unclear risk |
Funded by Farley Health Products |
