Review of guidelines on expression, storage and transport of breast milk for infants in hospital, to guide formulation of such recommendations in Sri Lanka

Abstract Background Sick newborns in neonatal units who are unable to breastfeed are fed expressed breast milk. In Sri Lanka, most mothers stay in hospital throughout baby’s stay to provide this milk freshly. In other countries mothers go home, express breast milk at home and bring it to hospital. There are concerns about the safety of transported expressed milk if used in a tropical middle-income country. The aim of this paper is to compare and contrast advice offered by different hospitals and organizations on how to express, store and transport breast milk safely. Methods We assessed guidelines used by hospital staff of the four Level 3 neonatal units in Melbourne, Australia, National Health Service UK, guidelines and training manuals of the Human Milk Banking Association of North America, the World Health Organization and an information leaflet from Family Health Bureau, Sri Lanka. Information on breast milk expression, storage and transport provided by the guidelines were tabulated under seven topics: general information; container for milk collection; hand expression; using a pump for expression; storage; thawing / warming; and transport of expressed breast milk. The AGREE II tool was used to assess the guidelines written for hospital staff. Results There was considerable agreement on most recommendations provided by these sources, but no single source covered all topics in full. Most recommend hand expression as the initial method for expressing of breast milk, followed by breast pump use, except the Sri Lankan recommendations which strongly discourages the use of breast pumps. Durations of storage under various conditions are generally similar in the different recommendations. Most guidelines recommend a ‘cool box’ or container with ice or freezer packs for transportation of milk. Conclusion A single document containing recommendations on all aspects of expressing, storing and transporting breast milk should be available for each unit, with the same basic information for mothers and the healthcare staff and further technical details for staff if required. The Sri Lankan recommendations need to be updated based on current worldwide practices and further studies are needed to establish a safe method of transport of expressed breast milk in Sri Lanka

Parental and professional perceptions of informed consent and participation in a time-critical neonatal trial: a mixed-methods study in India, Sri Lanka and Bangladesh

Introduction Time-critical neonatal trials in low-and-middle-income countries (LMICs) raise several ethical issues. Using a qualitative-dominant mixed-methods design, we explored informed consent process in Hypothermia for encephalopathy in low and middle-income countries (HELIX) trial conducted in India, Sri Lanka and Bangladesh.Methods Term infants with neonatal encephalopathy, aged less than 6 hours, were randomly allocated to cooling therapy or usual care, following informed parental consent. The consenting process was audio-video (A-V) recorded in all cases. We analysed A-V records of the consent process using a 5-point Likert scale on three parameters—empathy, information and autonomy. In addition, we used exploratory observation method to capture relevant aspects of consent process and discussions between parents and professionals. Finally, we conducted in-depth interviews with a subgroup of 20 parents and 15 healthcare professionals. A thematic analysis was performed on the observations of A-V records and on the interview transcripts.Results A total of 294 A-V records of the HELIX trial were analysed. Median (IQR) score for empathy, information and autonomy was 5 (0), 5 (1) and 5 (1), respectively. However, thematic analysis suggested that the consenting was a ceremonial process; and parental decision to participate was based on unreserved trust in the treating doctors, therapeutic misconception and access to an expensive treatment free of cost. Most parents did not understand the concept of a clinical trial nor the nature of the intervention. Professionals showed a strong bias towards cooling therapy and reported time constraints and explaining to multiple family members as key challenges.Conclusion Despite rigorous research governance and consent process, parental decisions were heavily influenced by situational incapacity and a trust in doctors to make the right decision on their behalf. Further research is required to identify culturally and context-appropriate strategies for informed trial participation

Additional file 4: of Hypothermia for encephalopathy in low and middle-income countries (HELIX): study protocol for a randomised controlled trial

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Hypothermia for moderate or severe neonatal encephalopathy in low-income and middle-income countries (HELIX): a randomised controlled trial in India, Sri Lanka, and Bangladesh

Copyright (c) 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license