Nutritional Support of Moderate and Late Preterm Infants: The DIAMOND Trial

CQ #300 – May 6, 2024
by Anne Eglash MD, IBCLC, FABM
#LACTFACT
There is no advantage to IV or oral nutritional supplementation beyond the mothers’ own milk, unless medically indicated, for moderate and late preterm infants.
The New England Journal of Medicine 2024;390:1493-504


Do moderate or late preterm infants (32-35 6/7 weeks gest) need intravenous or oral nutritional supplementation beyond mothers’ own milk (MOM)?

This is the 300th Clinical Question of the Week! I love sharing evidence to validate the central importance of lactation and to support clinicians and other stakeholders. I therefore use this blog to spotlight the most salient research, policies and guidelines that impact our clinical practices.

This week’s study, the DIAMOND Trial, is a multicenter trial of 532 mod-late preterm infants, (32-35 6/7 week gest) in New Zealand that sought to identify best practices in nutritional support while waiting for full maternal milk production. All mothers had the intention to breastfeed.

Each infant was assigned to three interventions or their comparators: intravenous amino acid solution (parenteral nutrition) or dextrose solution until full oral feeding; donor milk or formula supplementation when MOM was insufficient or MOM exclusively; and taste and smell exposure before tube feeding or no taste and smell exposure. Taste/smell exposure before tube feeding was hypothesized to aid GI function and reduce time to full enteral (GI) feeding.

All centers involved in the trial had lactation consultant support for the research participants.

The researchers measured time to full enteral feeding, infant growth during hospitalization (wt, length, head circumference), length of hospital stay, and body fat % at 4 months corrected age.

The data demonstrated that infants who received IV parenteral nutrition and either formula or donor milk supplementation received more protein, fat and calories than infants who received IV dextrose and primarily mothers’ own milk.

There was no difference in time to full enteral feeding with any of the interventions (IV parenteral nutrition, or dextrose, taste/smell exposure).

What else? See the question!

What do you think are findings from the DIAMOND trial that studied the effect of IV parenteral nutrition and donor milk/formula supplementation in a cohort of mod-late premature infants? Choose 1 or more:
  1. The infants who received more calories from IV nutrition and/or supplementation with donor milk or formula had a lower rate of breastfeeding at the time of discharge.
  2. The infants who received more calories from IV nutrition and/or supplementation with donor milk or formula had a higher body fat % at 4 months corrected age.
  3. Providing taste/smell of MOM when receiving gastric tube feedings shortened the time to full enteral (GI) feedings.
  4. Infants who received only IV dextrose and MOM (no IV parenteral nutrition, donor milk or formula) had no difference in growth during the NICU stay as compared to the infants who received extra calories from IV parenteral nutrition and/or oral supplementation.

See the Answer


Correct Answers: D (not A, B, or C)

The New England Journal of Medicine 2024;390:1493-504
Tanith Alexander, Sharin Asadi, Michael Meyer, Jane E. Harding, Yannan Jiang, Jane M. Alsweiler, Mariana Muelbert, and Frank H. Bloomfield, for the DIAMOND Trial Group

Abstract

Background

Most moderate-to-late–preterm infants need nutritional support until they are feeding exclusively on their mother’s breast milk. Evidence to guide nutrition strategies for these infants is lacking.

Methods

We conducted a multicenter, factorial, randomized trial involving infants born at 32 weeks 0 days’ to 35 weeks 6 days’ gestation who had intravenous access and whose mothers intended to breast-feed. Each infant was assigned to three interventions or their comparators: intravenous amino acid solution (parenteral nutrition) or dextrose solution until full feeding with milk was established; milk supplement given when maternal milk was insufficient or mother’s breast milk exclusively with no supplementation; and taste and smell exposure before gastric-tube feeding or no taste and smell exposure. The primary outcome for the parenteral nutrition and the milk supplement interventions was the body-fat percentage at 4 months of corrected gestational age, and the primary outcome for the taste and smell intervention was the time to full enteral feeding (150 ml per kilogram of body weight per day or exclusive breast-feeding).

Results

A total of 532 infants (291 boys [55%]) were included in the trial. The mean (±SD) body-fat percentage at 4 months was similar among the infants who received parenteral nutrition and those who received dextrose solution (26.0±5.4% vs. 26.2±5.2%; adjusted mean difference, −0.20; 95% confidence interval [CI], −1.32 to 0.92; P=0.72) and among the infants who received milk supplement and those who received mother’s breast milk exclusively (26.3±5.3% vs. 25.8±5.4%; adjusted mean difference, 0.65; 95% CI, −0.45 to 1.74; P=0.25). The time to full enteral feeding was similar among the infants who were exposed to taste and smell and those who were not (5.8±1.5 vs. 5.7±1.9 days; P=0.59). Secondary outcomes were similar across interventions. Serious adverse events occurred in one infant.

Conclusion

This trial of routine nutrition interventions to support moderate-to-late–preterm infants until full nutrition with mother’s breast milk was possible did not show any effects on the time to full enteral feeding or on body composition at 4 months of corrected gestational age. (Funded by the Health Research Council of New Zealand and others; DIAMOND Australian New Zealand Clinical Trials Registry number, ACTRN12616001199404.)

IABLE Comment by Anne Eglash MD, IBCLC, FABM

This trial essentially showed that these moderate-late premature infants grew similarly in the NICU and had similar body fat % at 4 months, no matter if they received IV dextrose or IV parenteral nutrition, and whether they received MOM or MOM plus donor milk/formula supplementation. The exclusive breastmilk feeding rates at discharge were not significantly different based on IV nutrition or oral supplementation. It is important to note that lactation support was provided at all study centers, and they withdrew donor milk/formula when MOM volume because sufficient. In addition, the average duration of IV nutrition was only 1 week.

A major lesson learned from this study is how data can be used to support opposing principles, and in this case, to either support nutritional supplementation OR exclusive breastfeeding.

First, note how their conclusion supports nutritional supplementation:
‘This trial of routine nutrition interventions to support moderate-to-late–preterm infants until full nutrition with mother’s breast milk was possible did not show any effects on the time to full enteral feeding or on body composition at 4 months of corrected gestational age.’

Their discussion, on the other hand, is much more supportive of exclusive breastfeeding:
‘These findings suggest that for infants of mothers who intend to breast-feed, the mode of nutritional support provided should be chosen to best support the eventual provision of mother’s breast milk as the sole enteral feed…These findings suggest that there is no benefit with respect to body composition in providing enriched nutritional support while waiting for sufficient mother’s breast milk to become available, even if the process takes several days’.

AND:
‘These findings indicate that among infants in neonatal nurseries in which there is dedicated lactation support for mothers who intend to breast-feed, as was the case in this trial, there is no benefit in providing infant formula or parenteral nutrition with respect to any of the outcomes we measured, and effort can be focused on ensuring that the mother’s milk supply is optimized.’

We each can decide for ourselves the clinical utility of these findings!



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