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. 2019 Jul 17;7(7):CD004204.
doi: 10.1002/14651858.CD004204.pub3.

Nutrient-enriched formula versus standard formula for preterm infants

Verena Walsh  1 , Jennifer Valeska Elli Brown, Lisa M Askie, Nicholas D Embleton, William McGuire
Affiliations

Nutrient-enriched formula versus standard formula for preterm infants

Verena Walsh et al. Cochrane Database Syst Rev. .

Abstract

Background: Preterm infants may accumulate nutrient deficits leading to extrauterine growth restriction. Feeding preterm infants with nutrient-enriched rather than standard formula might increase nutrient accretion and growth rates and might improve neurodevelopmental outcomes.

Objectives: To compare the effects of feeding with nutrient-enriched formula versus standard formula on growth and development of preterm infants.

Search methods: We used the Cochrane Neonatal standard search strategy. This included electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 11), MEDLINE, Embase, and the Cumulative Index to Nursing and Allied Health Literature (until November 2018), as well as conference proceedings, previous reviews, and clinical trials databases.

Selection criteria: Randomised and quasi-randomised controlled trials that compared feeding preterm infants with nutrient-enriched formula (protein and energy plus minerals, vitamins, or other nutrients) versus standard formula.

Data collection and analysis: We extracted data using the Cochrane Neonatal standard methods. Two review authors separately evaluated trial quality and extracted and synthesised data using risk ratios (RRs), risk differences, and mean differences (MDs). We assessed certainty of evidence at the outcome level using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methods.

Main results: We identified seven trials in which a total of 590 preterm infants participated. Most participants were clinically stable preterm infants of birth weight less than 1850 g. Few participants were extremely preterm, extremely low birth weight, or growth restricted at birth. Trials were conducted more than 30 years ago, were formula industry funded, and were small with methodological weaknesses (including lack of masking) that might bias effect estimates. Meta-analyses of in-hospital growth parameters were limited by statistical heterogeneity. There is no evidence of an effect on time to regain birth weight (MD -1.48 days, 95% confidence interval (CI) -4.73 to 1.77) and low-certainty evidence suggests that feeding with nutrient-enriched formula increases in-hospital rates of weight gain (MD 2.43 g/kg/d, 95% CI 1.60 to 3.26) and head circumference growth (MD 1.04 mm/week, 95% CI 0.18 to 1.89). Meta-analysis did not show an effect on the average rate of length gain (MD 0.22 mm/week, 95% CI -0.70 to 1.13). Fewer data are available for growth and developmental outcomes assessed beyond infancy, and these do not show consistent effects of nutrient-enriched formula feeding. Data from two trials did not show an effect on Bayley Mental Development Index scores at 18 months post term (MD 2.87, 95% CI -1.38 to 7.12; moderate-certainty evidence). Infants who received nutrient-enriched formula had higher Bayley Psychomotor Development Index scores at 18 months post term (MD 6.56. 95% CI 2.87 to 10.26; low-certainty evidence), but no evidence suggested an effect on cerebral palsy (typical RR 0.79, 95% CI 0.30 to 2.07; 2 studies, 377 infants). Available data did not indicate any other benefits or harms and provided low-certainty evidence about the effect of nutrient-enriched formula feeding on the risk of necrotising enterocolitis in preterm infants (typical RR 0.72, 95% CI 0.41 to 1.25; 3 studies, 489 infants).

Authors' conclusions: Available trial data show that feeding preterm infants nutrient-enriched (compared with standard) formulas has only modest effects on growth rates during their initial hospital admission. No evidence suggests effects on long-term growth or development. The GRADE assessment indicates that the certainty of this evidence is low, and that these findings should be interpreted and applied with caution. Further randomised trials would be needed to resolve this uncertainty.

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Conflict of interest statement

NDE declares the following: receiving a research grant award for an RCT of breast milk products by Prolacta Bioscience, 2017; receiving a grant from Danone Early Life Nutrition to support a study on feeding in late and moderately preterm infants, 2018; receiving a grant from Nestle Nutrition for transcriptomic analyses of gut tissue, 2016; lectures with Wyeth Nutrition in 2017, Nestle Nutrition Institute in 2017 and 2018, Philipps in 2017, and Fresenius, 2017.

VW has no conflicts of interest.

JB has no conflicts of interest.

LA has no conflicts of interest.

WM has no conflicts of interest.

Core editorial and administrative support for this review has been provided by a grant from The Gerber Foundation. The Gerber Foundation is a separately endowed, private foundation, distinct from the Gerber Products Company. The grantor has no input on the content of the review nor on the editorial process.

To maintain the utmost editorial independence for this Cochrane Review, an editor outside of the Cochrane Neonatal core editorial team who is not receiving any financial remuneration from the grant, Eugene Dempsey, was the Sign‐off Editor for this review. Additionally, a Senior Editor from the Cochrane Children and Families Network, Robert Boyle, assessed and signed off on this Cochrane Review.

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
3
3
Forest plot of comparison: 1 Nutrient‐enriched formula vs standard formula, outcome: 1.2 Rate of weight gain (g/kg/d).
4
4
Forest plot of comparison: 1 Nutrient‐enriched formula vs standard formula, outcome: 1.3 Rate of length gain (mm/week).
5
5
Forest plot of comparison: 1 Nutrient‐enriched formula vs standard formula, outcome: 1.4 Rate of head circumference gain (mm/week).
6
6
Forest plot of comparison: 1 Nutrient‐enriched formula vs standard formula, outcome: 1.18 Bayley (1) Mental Development Index at 18 months post term.
1.1
1.1. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 1 Time to regain birth weight.
1.2
1.2. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 2 Rate of weight gain (g/kg/d).
1.3
1.3. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 3 Rate of length gain (mm/week).
1.4
1.4. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 4 Rate of head circumference gain (mm/week).
1.5
1.5. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 5 Rate of skinfold thickness gain ‐ triceps (mm/week).
1.6
1.6. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 6 Rate of skinfold thickness gain ‐ subscapular (mm/week).
1.7
1.7. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 7 Weight (kg) at 18 months post term.
1.8
1.8. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 8 Weight (kg) at 7.5 to 8 years post term.
1.9
1.9. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 9 Height (cm) at 18 months post term.
1.10
1.10. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 10 Height (cm) at 7.5 to 8 years post term.
1.11
1.11. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 11 Head circumference (cm) at 18 months post term.
1.12
1.12. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 12 Head circumference (cm) at 7.5 to 8 years post term.
1.13
1.13. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 13 Triceps skinfold thickness (mm) at 18 months post term.
1.14
1.14. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 14 Triceps skinfold thickness (mm) at 7.5 to 8 years post term.
1.15
1.15. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 15 Subscapular skinfold thickness (mm) at 18 months post term.
1.16
1.16. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 16 Subscapular skinfold thickness (mm) at 7.5 to 8 years post term.
1.17
1.17. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 17 Cerebral palsy at 18 months post term.
1.18
1.18. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 18 Bayley (1) Mental Development Index at 18 months post term.
1.19
1.19. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 19 Weschler Verbal Intelligence Quotient at 7.5 to 8 years post term.
1.20
1.20. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 20 Bayley (1) Psychomotor Development Index at 18 months post term.
1.21
1.21. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 21 Weschler Performance Intelligence Quotient at 7.5 to 8 years post term.
1.22
1.22. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 22 Weschler Overall Intelligence Quotient at 7.5 to 8 years post term.
1.23
1.23. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 23 Necrotising enterocolitis.
1.24
1.24. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 24 Duration of birth hospitalisation.
1.25
1.25. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 25 All‐cause mortality.
1.26
1.26. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 26 Body mass index (kg/m²) at 18 months post term.
1.27
1.27. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 27 Body mass index (kg/m²) at 7.5 to 8 years post term.
1.28
1.28. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 28 Waist‐to‐hip ratio at 7.5 to 8 years post term.
1.29
1.29. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 29 Serum alkaline phosphatase level after 4 weeks (IU/mL).
1.30
1.30. Analysis
Comparison 1 Nutrient‐enriched formula vs standard formula, Outcome 30 Bone mineral content (g) assessed by DEXA at 8 to 12 years.
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