Standard Operating Procedure for POP Sampling in Breast Milk

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Standard Operating Procedure for POP Sampling in Breast Milk Page 5 of 20 The professionals acknowledge the importance of breastfeeding and encourage the potential donors to breastfeed. One of the issues to be considered when selecting the Banks is the ease with which the samples can be sent fast to the laboratory that coordinates the study, located in areas with a high population density. All the Banks will be contacted, and after clarifying the purpose of the study, a pre-selection will be made among those that show interest and willingness to collaborate. The banks selected must represent their countries. The countries should be divided into more regions and the banks available in each region should be selected at random, to ensure a vast geographical distribution of the sampling sites across the country. To determine the total number of Banks needed, the country coordination will have to: Determine the total number of individual samples that need to be collected Consider that at least 5 samples will have to be collected per site, with a maximum of 10 samples per site; The same number of samples will be collected per site (UNEP composite sample - 50 persons - five regions – two BMBs per region – five samples per BMB) 5.3 Training of collaborators After selecting the breast milk banks and hospitals, the study coordinators will visit the sites selected to inform about the study details and the training it involves, the selection of donors and the implementation of the questionnaire, as well as to clarify any doubts that may arise when the procedures are implemented. At that briefing visit, the coordinators will leave the previously prepared collection jars and all the material that will be needed (e.g.: questionnaires). 5.4 Selection of donors and implementation of questionnaire The potential donors will be recruited among mothers that seek a milk bank to donate milk or who donate milk at the hospital. Primarily, they must meet the selection criteria recommended in the guide developed by WHO: Primiparas; Mothers not older than 30 years of age; Both mother and child must be apparently healthy, and pregnancy had to be normal; The mother must be breastfeeding only one child (e.g.: no twins);
Standard Operating Procedure for POP Sampling in Breast Milk Page 6 of 20 Only mothers that have lived at least ten years in the area must be included; Only mothers that are exclusively or primarily breastfeeding must be included; The mother must not live in the vicinity of incinerators, paper mills, metal factories and chemicals factories; The mother must be available for the extraction of the sample between the third and eighth week postpartum. The mothers that meet all these requirements will be invited to participate in the study by signing the Consent Agreement (Annex 4). Each mother included in the study must be identified with a single code, the same that will appear by her name in the List of Participants (Annex 5). This code will be recorded in the Selection Guide, in the Consent Agreement, in the Individual Questionnaire and the collection jar. Before the milk is collected, the donor will be interviewed by a milk bank professional, and will provide information about her housing and feeding habits, in accordance with the Individual Questionnaire (Annex 6). 5.5 Extraction, storage and transport of samples The collection will be conducted at the human milk banks between the 3 th and 8 th weeks postpartum. The total volume of the breast milk to be sampled from each mother will be 100 ml. This volume can be obtained easily without impairing the infant’s feeding. No other containers may be used to collect the milk. Preferably, the extraction must be performed manually, expressing the milk directly into the jar provided for that purpose. Breasts and hands should be maintained as clean as possible, avoiding the use of soap. When the mother is using some ointment (for cracked nipples, or other medical reasons), the application must be limited to the moments between the extractions of milk, and the product should be completely removed, washing the breasts prior to the procedure. Each mother must be given an identification code number, to match the code on the milk collection jar. The jars are supplied by the study coordinators, after they have undergone an adequate chemical treatment to ensure they are free from contamination, and with three potassium dichromate pellets to preserve the samples appropriately. The sample must be collected directly into the container; if the sample is taken at the mother’s home, the jar must be refrigerated until its delivery. The sample may be kept in the refrigerator, at approximately 4 °C, for no longer than 72 hours, or in the freezer, at -20 °C, for longer periods. If the sample cannot be refrigerated, you can add a small tablet of potassium dichromate (K2Cr2O7) for chemically sterilized milk. After the collection of samples, the fifty 50-ml samples must be sent to the laboratory appointed by the Country Coordinator. Sample shipment must be performed by professional carriers or through other means, as expeditiously as possible. Samples are frozen at -20 °C, wrapped in dry ice and sent to destination. In the countries where the temperature cannot be controlled, the samples are preserved by adding 100 mg of potassium dichromate every 250 ml of milk. All the individual or composite samples must carry a label with one single identification code. The composite samples must be sent to the WHO Reference Laboratory, together with the summarized information (see Annex 8). The laboratory that receives the samples must be informed on the shipping date and the expected date of arrival, and must confirm their reception.
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Standard Operating Procedure for POP Sampling in Breast Milk

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