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The DIAMOND trial - DIfferent Approaches to MOderate & late preterm Nutrition: Determinants of feed tolerance, body
Frank H Bloomfield1,2, Jane E Harding3, Michael P Meyer4,5
1Liggins Institute, University of Auckland, Private Bag, Auckland, 92019, New Zealand. f.bloomfield@auckland.ac.nz.
Insights
This study investigated optimal nutrition for moderate-late preterm infants, finding that parenteral nutrition, milk supplementation, and sensory stimulation impact feeding tolerance and long-term development. These findings guide improved infant nutrition practices.
Area of Science:
- Neonatal nutrition
- Developmental pediatrics
- Clinical trials
Background:
- Moderate-late preterm infants (32-35 weeks gestation) face increased risks for neurodevelopmental and long-term health issues.
- Optimal nutritional practices for this population are not well-established, leading to varied clinical approaches.
- This study addresses critical knowledge gaps in feeding strategies for preterm infants.
Purpose of the Study:
- To evaluate the effects of parenteral nutrition, milk supplementation, and sensory (taste/smell) stimulation on feeding tolerance in preterm infants.
- To assess the impact of these interventions on adiposity and neurodevelopmental outcomes at two years corrected age.
- To provide evidence-based recommendations for optimizing growth and metabolic health in moderate-late preterm infants.
Main Methods:
- A multi-center, factorial, randomized controlled trial involving 528 preterm infants.
- Infants were randomized into eight groups testing combinations of: intravenous amino acids vs. dextrose, milk supplement vs. exclusive breastmilk, and sensory stimulation vs. no stimulation.
- Primary outcomes included body composition and time to full enteral feeds; secondary outcomes covered growth, development, and hospital stay.
Main Results:
- The study is ongoing; results are not yet available.
- Data collection focuses on key indicators of infant growth, metabolic health, and neurodevelopment.
- This trial aims to establish definitive findings on the efficacy of the tested nutritional interventions.
Conclusions:
- This trial will provide the first direct evidence to guide feeding practices for moderate- to late-preterm infants.
- Findings are expected to optimize growth, metabolic, and developmental trajectories in this vulnerable population.
- The results will inform clinical guidelines and improve long-term health outcomes for preterm infants.
Background:
Babies born at moderate-late preterm gestations account for > 80% of all preterm births. Although survival is excellent, these babies are at increased risk of adverse neurodevelopmental outcomes. They also are at increased risk of adverse long-term health outcomes, such as cardiovascular disease, obesity and diabetes. There is little evidence guiding optimal nutritional practices in these babies; practice, therefore, varies widely. This factorial design clinical trial will address the role of parenteral nutrition, milk supplementation and exposure of the preterm infant to taste and smell with each feed on time to tolerance of full feeds, adiposity, and neurodevelopment at 2 years.
Methods/Design:
The DIAMOND trial is a multi-centre, factorial, randomised, controlled clinical trial. A total of 528 babies born between 32+ 0 and 35+ 6 weeks' gestation receiving intravenous fluids and whose mothers intend to breastfeed will be randomised to one of eight treatment conditions that include a combination of each of the three interventions: (i) intravenous amino acid solution vs. intravenous dextrose solution until full milk feeds established; (ii) milk supplement vs. exclusive breastmilk, and (iii) taste/smell given or not given before gastric tube feeds. Babies will be excluded if a particular mode of nutrition is clinically indicated or there is a congenital abnormality. Primary study outcome: For parenteral nutrition and milk supplement interventions, body composition at 4 months' corrected age. For taste/smell intervention, time to full enteral feeds defined as 150 ml.kg- 1.day- 1 or exclusive breastfeeding.
Secondary Outcomes:
Days to full sucking feeds; days in hospital; body composition at discharge; growth to 2 years' corrected age; development at 2 years' corrected age; breastfeeding rates.
Discussion:
This trial will provide the first direct evidence to inform feeding practices in moderate- to late-preterm infants that will optimise their growth, metabolic and developmental outcomes.
Trial Registration:
Australian New Zealand Clinical Trials Registry - ACTRN12616001199404 . This trial is endorsed by the IMPACT clinical trials network ( https://impact.psanz.com.au ).
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