Aims When human milk is not available for preterm infants, protein hydrolysate formulas are increasingly used because they are perceived as being tolerated better, and less likely to lead to complications, than standard cow’s milk formulas. Protein hydrolysate formulas, however, are more expensive than standard formulas, and concern exists that their use in practice is not supported by high-quality evidence. We aimed to assess the trial evidence for the effect of feeding protein hydrolysate versus standard formulas on the risk of feed intolerance, necrotising enterocolitis (NEC), and other morbidity in preterm infants.
Methods Cochrane systematic review of randomised controlled trials (RCTs). We used the standard search strategy of the Cochrane Neonatal Review Group. 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 (RR) and risk differences (RD) for dichotomous data, and mean differences (MDs) for continuous data, with respective 95% confidence intervals (CIs). We used a fixed-effect model in meta-analyses and explored potential causes of heterogeneity by performing sensitivity analyses. We assessed quality of evidence at the outcome level using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
Results We identified nine trials. All were small (total participants 552) and had various methodological limitations including uncertainty about allocation concealment and blinding. Overall, the trials did not show any statistically significant effects on feed intolerance assessed variously as average pre-feed gastric residual volume, incidence of concerning gastro-intestinal signs, or time taken to achieve full enteral feeds (moderate or low quality evidence). Meta-analysis did not show a significant effect on the risk of NEC: typical RR 1.10 [95% CI 0.36 to 3.34]; RD 0.00 [95% CI 0.04, 0.04] (moderate quality evidence).
Conclusions Currently available data from RCTs indicate that feeding preterm infants with protein hydrolysate versus standard formula does not affect the risk of feed intolerance or NEC. Further pragmatic RCTs could provide more precise estimates of effectiveness and cost-effectiveness.
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