Absence of Evidence of Beneficial Effects of Human Milk‐Based Fortifier: A Bayesian Model‐Averaged Meta‐Analysis

Aim Human milk‐based fortifiers ( HMBFs ) have been adopted in neonatal care despite limited efficacy data. Our objective was to conduct a Bayesian re‐analysis of the current evidence on the protective effect of HMBF against necrotising enterocolitis ( NEC , stage II ‐ III ). Methods We searched for randomised controlled trials ( RCTs ) comparing HMBF versus bovine milk‐based fortifier ( BMBF ) in infants with gestational age < 32 weeks or birthweight < 1500 g. Bayesian model‐averaged ( BMA ) meta‐analysis was used to calculate Bayes factors ( BFs ). The BF 10 is the ratio of the probability of the data under the alternative hypothesis ( H 1 , presence of effect) over the probability of the data under the null hypothesis ( H 0 , absence of effect). Results We included 3 RCTs (405 infants). The BMA analysis did not show conclusive evidence in favour of H 1 ( BF 10 > 3) or in favour of H 0 ( BF 10 < 1/3) for NEC ( BF 10 = 0.86), mortality ( BF 10 = 1.07), late onset sepsis ( BF 10 = 0.69), bronchopulmonary dysplasia ( BPD , BF 10 = 0.92), or severe retinopathy of prematurity ( ROP , BF 10 = 0.75). Conclusions The extant corpus of RCTs does not provide sufficient evidence to either confirm or exclude a potential effect of HMBF compared with BMBF on the risk of NEC , mortality, sepsis, BPD , or severe ROP .