Assessing the impact of different donor milk treatments on infant health and growth: a systematic review protocol

Introduction: Donor human milk (DHM) is the first alternative if mother's own milk is unavailable or contraindicated. Much DHM research has focused on its nutritional, immunological and biochemical composition in response to various maternal variables, standard human milk banking procedures and storage protocols. The current systematic review protocol, however, aims to systematically gather and analyse existing data pertaining to the impact of these aforementioned factors on the clinical, health-related and developmental outcomes observed in infants fed with DHM.

Methods and analysis: We will apply a predefined search strategy including Cochrane Central Register of Controlled Trials, Global Index Medicus, CINAHL on Ebscohost, Medline, Embase, Emcare, Pubmed, Global Health on OVID, Google Scholar, clinicaltrials.gov, the WHO International Trials Registry and Platform and the European Union/European Economic Area Clinical Trials Register. No setting, patient population, date or language restrictions will be applied. The search strategy will consist of search words on the key concepts of 'donated human milk' and 'effect on infants'. Published or unpublished primary research studies are eligible for inclusion if there is an abstract available in English. Conference proceedings, animal studies and publications with no original data will be excluded.Authors of unpublished or partially published studies will be contacted and eligible data added if provided. Risk of bias will be evaluated according to CASP using appropriate tools depending on study type (RoB 2, ROBINS-I, Newcastle Ottawa Scale). Data will be synthesised in a quantitative format describing significant results as well as presenting the results of the quality assessment of studies.

Ethics and dissemination: This systematic review does not require ethical approval, as we will not collect primary data. The review will be published in a peer-reviewed journal and disseminated electronically and in print.

Prospero registration number: CRD42024522015.