Nutritional management of growth faltering in infants aged under six months in Asia and Africa (BRANCH, Breastfeeding counselling and management of growth)

Interventions for all infants - all infants in the intervention and comparator groups will receive visits for clinical assessment and management and intensive breastfeeding (BF) counselling and support . The first visit will be within 24 hours from the time growth faltering (GF) is identified. Subsequent visits will be on day 1, 3, 7 and then weekly until the GF has resolved. The visits will be approximately 30 mins duration and will be provided by a trained study team. The content will be: - Clinical assessment of management of health by trained nurses and doctors using WHO Integrated Management of Childhood Illness materials https://iris.who.int/bitstream/handle/10665/326448/9789241516365-eng.pdf?sequence=1, and WHO Pocket Book of Hospital Care for Children materials https://iris.who.int/bitstream/handle/10665/81170/9789241548373_eng.pdf?sequence=1 adapted for local site specific requirements. There will also be referral to other health services if needed. - Intensive BF counselling and support using the WHO Guideline: Counselling of women to improve breastfeeding practices https://iris.who.int/bitstream/handle/10665/280133/9789241550468-eng.pdf?sequence=1 The intervention group will receive visits for clinical assessment and management and intensive breastfeeding (BF) counselling and support on day 1,3,7 and then weekly until the GF has resolved as described above plus the study prescription of the nutritional milk supplement (NMS) . The details of the NMS are described below: -Type of NMS - The NMS will be standard commercially available ‘term’ formula milk that meets Food and Drug Organization (FAO) and Codex Alimentarius (https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B72-1981%252FCXS_072e.pdf ) requirements for formula milk for infants aged 0 to < 6 months. The NMS will be procured by UNICEF in six sites (Bangladesh, Ethiopia, Nigeria, Pakistan, Tanzania, Uganda) and there will be incountry procurement in one site (India) due to country regulations. - Method of NMS provision - The responsive feeding method will be used to provide the NMS to the infant. i.e. ‘responsive NMS feeding’ will be provided . WHO and UNICEF define responsive feeding as recognizing the infants’ cues for feeding, closeness and comfort, and responding accordingly to these cues. Mothers will be trained and counselled in the responsive NMS feeding by the supplement team using the methods described in the WHO publication https://iris.who.int/bitstream/handle/10665/259386/9789241550086-eng.pdf?sequence=1 . The mother will be advised to give the NMS only after full support for breastfeeding has been provided i.e. after breastfeeding. The Infant will be offered the NMS feeds at least 6 times a day, and whenever the Infant is cueing or appears hungry. The infant will be fed according to infant’s cues and will not be force-fed or tube-fed. If the Infant is cueing and still appears hungry after the NMS is finished then the infant will be offered additional NMS and as much NMS as the infant wishes -NMS amount – To calculate the minimum amount of NMS to be offered to the infant at each feed, the minimum amount of energy (kilo calories, kcals) required for catch up growth ( called in this trial the ‘catch up calories’) will be calculated using guidelines adapted from ESPGHAN (European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) 2005:41;S5–S11 https://journals.lww.com/jpgn/fulltext/2005/11002/ 2__energy.2.aspx and FAO/WHO/UNU (Food and Agriculture Organization of the United Nations/World Health Organization/United Nations University) 2004. Human energy requirements. https://www.fao.org/4/y5686e/y5686e05.htm . The standard energy requirement (SER) for infants aged 0 to < 6 months of 100 kcals/kg.day will be multiplied by the ratio of the ‘target weight’ (TW*) divided by the ‘actual weight’ (AW*) as defined below. (i.e. catch up calories = SER x TW/AW) . The calculated ‘catch up calories’ will then be multiplied by the kcals / ml specified in the product specifications (67 kcals/100mls for the Unicef procured NMS) to provide the minimum mls/kg/day of NMS to be provided to the infant. -Frequency – The NMS will be offered to the infant at least six times per day, and as many times as the Infant demands. The infant’s cues will be monitored carefully by the mother and additional feeds will be offered as soon as the infant cues indicate. -NMS preparation. The NMS will be prepared according to manufacturers’ instructions. Mothers will be shown how to prepare the NMS and counselled on safe preparation and techniques using standard WHO guidance https://www.who.int/publications/i/item/9789241595414 adapted for local site specific requirements. Mothers will also be advised on the risks of diarrhoeal illness and will be given clear guidance on seeking medical care early. -Monitoring and review – The infant will be reviewed on day 1, 3, 7 and then weekly until the infant reaches the recovery point. Adherence to both the breastfeeding support and the NMS will be monitored by the trial data management system (number and duration of visits and intake of the NMS).. Recovery point and stopping the NMS - The NMS will be provided until the infant has reached the recovery point* i.e. the infant has regained their ‘healthy centile’ (as defined below*) and maintained it for eight weeks. The NMS will be stopped at that time and the infant will resume standard BF counselling and support and 2 weekly growth monitoring. *Definitions for NMS provision used in this trial are as follows: -‘actual weight’ = weight of the infant at the time of the assessment -‘target weight’ = weight at which the infant has regained their ‘healthy centile’ in 4 weeks -‘healthy centile’ = weight for age centile / z score before growth problems started