The DIAMOND trial – DIfferent Approaches to MOderate & late preterm Nutrition: Determinants of feed tolerance, body composition and development: protocol of a randomised trial

Abstract

More rapid growth in infancy may protect the infant from cognitive impairment but is linked to childhood adiposity, persisting through adulthood [9], suggesting that there may be a trade-off in preterm babies whereby providing enhanced nutrition to prevent postnatal growth faltering results in better brain growth and cognitive outcomes, but accelerates weight gain thus increasing the risk of later metabolic and cardiovascular disease [9]. Secondary outcomes Time to full sucking feeds; number of days in hospital; body composition at discharge; growth: length, weight and head circumference Z-scores and Z-score change from birth to 4 months’ corrected age and at 2 years’ corrected age; developmental assessment at 2 years’ corrected age; breastfeeding rates; nutritional intake from birth to full enteral feeds or until 28 days of age. A total of 480 babies (n = 240 per intervention arm) will provide ≥90% power at an overall type 1 error rate of 5% to detect a minimal clinically significant difference in % fat mass at 4 months’ correct age of 3% (lower 95% confidence interval) for parental nutrition and milk supplement interventions, or to detect a reduction in median time to full enteral feeds from 10 to 7 days (hazard ratio 1.43) with the taste/smell intervention. Discussion This multi-centre, factorial design clinical trial aims to assess the effects of different feeding strategies in current use for moderate to late preterm infants on body composition, feed tolerance and neurodevelopmental outcome. [...]data from large, well-designed randomised trials are available to assess the effects of current feeding strategies on outcomes it is difficult to develop and recommend evidence-based nutrition guidelines.