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. 2019 Jul 24;7(7):CD012412.
doi: 10.1002/14651858.CD012412.pub3.

Protein hydrolysate versus standard formula for preterm infants

Derek Hang Cheong Ng  1 , Joel Rl Klassen, Nicholas D Embleton, William McGuire
Affiliations

Protein hydrolysate versus standard formula for preterm infants

Derek Hang Cheong Ng et al. Cochrane Database Syst Rev. .

Abstract

Background: When human milk is not available for feeding preterm infants, protein hydrolysate, rather than standard cow's milk formulas (with intact proteins), is often used because it is perceived as being tolerated better and less likely to lead to complications. However, protein hydrolysate formulas are more expensive than standard formulas, and concern exists that their use in practice is not supported by high-quality evidence.

Objectives: To assess the effects of feeding preterm infants hydrolysed formula (vs standard cow's milk formula) on risk of feed intolerance, necrotising enterocolitis, and other morbidity and mortality.

Search methods: We used the standard Cochrane Neonatal search strategy including electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 1), in the Cochrane Library; Ovid MEDLINE (1966 to 28 January 2019); Ovid Embase (1980 to 28 January 2019); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (28 January 2019), as well as conference proceedings and previous reviews.

Selection criteria: Randomised and quasi-randomised controlled trials that compared feeding preterm infants protein hydrolysate versus standard (non-hydrolysed) cow's milk formula.

Data collection and analysis: Two review authors assessed trial eligibility and risk of bias and extracted data independently. We analysed treatment effects as described in the individual trials and reported risk ratios and risk differences for dichotomous data, and mean differences for continuous data, with respective 95% confidence intervals (CIs). We used a fixed-effect model in meta-analyses and explored potential causes of heterogeneity in sensitivity analyses. We assessed quality of evidence at the outcome level using the GRADE approach.

Main results: We identified 11 trials for inclusion in the review. All trials were small (total participants 665) and had various methodological limitations including uncertainty about methods to ensure allocation concealment and blinding. Most participants were clinically stable preterm infants of less than about 34 weeks' gestational age or with birth weight less than about 1750 g. Fewer participants were extremely preterm, extremely low birth weight, or growth restricted. Most trials found no effects on feed intolerance, assessed variously as mean pre-feed gastric residual volume, incidence of abdominal distension or other gastrointestinal signs of concern, or time taken to achieve full enteral feeds (meta-analysis was limited because studies used different measures). Meta-analysis showed no effect on the risk of necrotising enterocolitis (typical risk ratio 1.10, 95% CI 0.36 to 3.34; risk difference 0.00, 95% CI -0.03 to 0.04; 5 trials, 385 infants) (low-certainty evidence; downgraded for imprecision and design weaknesses).

Authors' conclusions: The identified trials provide only low-certainty evidence about the effects of feeding preterm infants protein hydrolysate versus standard formula. Existing data do not support conclusions that feeding protein hydrolysate affects the risk of feed intolerance or necrotising enterocolitis. Additional large, pragmatic trials are needed to provide more reliable and precise estimates of effectiveness and cost-effectiveness.

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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.

DN has no interest to declare.

JK has no interest to declare.

WM has no interest to declare.

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, independent from the Gerber Products Company. The grantor has no input on the content of the review or the editorial process (see Sources of support).

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, Jann Foster, 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 (updated January 2019).
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 Hydrolysed versus non‐hydrolysed formula, outcome: 1.2 Necrotising enterocolitis.
4
4
Forest plot of comparison: 1 Hydrolysed versus non‐hydrolysed formula, outcome: 1.4 Weight gain (g/kg/d).
5
5
Forest plot of comparison: 1 Hydrolysed versus non‐hydrolysed formula, outcome: 1.7 Serum alkaline phosphatase (IU/L).
1.1
1.1. Analysis
Comparison 1: Hydrolysed versus non‐hydrolysed formula, Outcome 1: Feed intolerance
1.2
1.2. Analysis
Comparison 1: Hydrolysed versus non‐hydrolysed formula, Outcome 2: Necrotising enterocolitis
1.3
1.3. Analysis
Comparison 1: Hydrolysed versus non‐hydrolysed formula, Outcome 3: Time to full enteral feeding
1.4
1.4. Analysis
Comparison 1: Hydrolysed versus non‐hydrolysed formula, Outcome 4: Weight gain (g/kg/day)
1.5
1.5. Analysis
Comparison 1: Hydrolysed versus non‐hydrolysed formula, Outcome 5: Length gain (mm/week)
1.6
1.6. Analysis
Comparison 1: Hydrolysed versus non‐hydrolysed formula, Outcome 6: Head circumference growth (mm/week)
1.7
1.7. Analysis
Comparison 1: Hydrolysed versus non‐hydrolysed formula, Outcome 7: Serum alkaline phosphatase (IU/L)
1.8
1.8. Analysis
Comparison 1: Hydrolysed versus non‐hydrolysed formula, Outcome 8: Late‐onset invasive infection
1.9
1.9. Analysis
Comparison 1: Hydrolysed versus non‐hydrolysed formula, Outcome 9: Any allergic disease
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References

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