A Landscape Analysis of Human Milk Banks in India.

OBJECTIVES: To evaluate the existing status of human milk banks in India with reference to infrastructure, human resources, funding mechanisms, operating procedures and quality assurance. METHODS: A pretested questionnaire was administered to 16 out of 22 human milk banks across India, operational for more than one year prior to commencing the study. RESULTS: 11 (69%) milk banks were in government or charitable hospitals; only 2 (12.5%) were established with government funding. 8 (50%) had a dedicated technician and only 1(6%) had more than five lactation counsellors. Milk was collected predominantly from mothers of sick babies and in postnatal care wards followed by pediatric outpatient departments, camps, satellite centers, and homes. 10 (63%) reported gaps between donor milk demand and supply. 12 (75%) used shaker water bath pasteurizer and cooled the milk manually without monitoring temperature, and 4 (25%) pooled milk under the laminar airflow. 10 (63%) tracked donor to recipient and almost all did not collect data on early initiation, exclusive breastfeeding or human milk feeding. CONCLUSIONS: Our study reports the gaps of milk banking practices in India, which need to be addressed for strengthening them. Gaps include suboptimal financial support from the government, shortage of key human resources, processes and data gaps, and demand supply gap of donor human milk.

Understanding Barriers and Facilitators for Human Milk Banking Among Service Providers, Mothers, and Influencers of Preterm and Sick Neonates Admitted at Two Health Facilities in a Metropolitan City in India.

BACKGROUND: Scaling-up human milk banks (HMBs) is a promising solution for saving vulnerable newborns. Exploring perceptions and practices on donor human milk (DHM) and HMBs is essential to strengthen and scale-up an integrated HMB system resting on a model called the "Mother Baby Friendly Initiative Plus" (MBFI+), which includes promoting breastfeeding, encouraging kangaroo mother care, and providing safe DHM to vulnerable babies without access to mother's own milk. MATERIALS AND METHODS: A qualitative research was conducted among 56 service recipients including mothers and key influencers and 9 service providers to understand their perceptions and practices on DHM and HMBs. RESULTS: Service providers opined that DHM is safe and lifesaving for vulnerable babies. Challenges shared were limited supply of DHM because of low awareness on milk donation, shortage of trained staff, and risk of milk contamination. They stated that although most mothers were comfortable in donating milk, few were reluctant to donate milk as they feared shortage of milk for their own babies, or milk expression may cause weakness. Recipient mothers accepted use of DHM as per facility norms but had concerns about donor mothers' health and hygiene and measures for ensuring milk safety. Most grandmothers were resistant toward donating or receiving DHM for their grandchildren. Many fathers were comfortable with donating once they knew it is lifesaving and did not compromise supply for their babies. Service providers shared opportunities for scale-up, like improving awareness and infrastructure, lactation counseling by skilled personnel, supportive hospital environment, and establishing HMBs in every city and district. CONCLUSIONS: Human milk banking should be strengthened as part of the MBFI+ model. For this, behavior change communication targeted at mothers and influencers about breastfeeding and HMB from the antenatal period, capacity-building among service providers, and government ownership is necessary.

Hypothermia for encephalopathy in low-income and middle-income countries: feasibility of whole-body cooling using a low-cost servo-controlled device.

Although therapeutic hypothermia (TH) is the standard of care for hypoxic ischaemic encephalopathy in high-income countries, the safety and efficacy of this therapy in low-income and middle-income countries (LMICs) is unknown. We aimed to describe the feasibility of TH using a low-cost servo-controlled cooling device and the short-term outcomes of the cooled babies in LMIC. DESIGN: We recruited babies with moderate or severe hypoxic ischaemic encephalopathy (aged <6 hours) admitted to public sector tertiary neonatal units in India over a 28-month period. We administered whole-body cooling (set core temperature 33.5°C) using a servo-controlled device for 72 hours, followed by passive rewarming. We collected the data on short-term neonatal outcomes prior to hospital discharge. RESULTS: Eighty-two babies were included-61 (74%) had moderate and 21 (26%) had severe encephalopathy. Mean (SD) hypothermia cooling induction time was 1.7 hour (1.5) and the effective cooling time 95% (0.08). The mean (SD) hypothermia induction time was 1.7 hour (1.5 hour), core temperature during cooling was 33.4°C (0.2), rewarming rate was 0.34°C (0.16°C) per hour and the effective cooling time was 95% (8%). Twenty-five (51%) babies had gastric bleeds, 6 (12%) had pulmonary bleeds and 21 (27%) had meconium on delivery. Fifteen (18%) babies died before discharge from hospital. Heart rate more than 120 bpm during cooling (P=0.01) and gastric bleeds (P<0.001) were associated with neonatal mortality. CONCLUSIONS: The low-cost servo-controlled cooling device maintained the core temperature well within the target range. Adequately powered clinical trials are required to establish the safety and efficacy of TH in LMICs. CLINICAL TRIAL REGISTRATION NUMBER: NCT01760629.

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

BACKGROUND: Therapeutic hypothermia reduces death and disability after moderate or severe neonatal encephalopathy in high-income countries and is used as standard therapy in these settings. However, the safety and efficacy of cooling therapy in low- and middle-income countries (LMICs), where 99% of the disease burden occurs, remains unclear. We will examine whether whole body cooling reduces death or neurodisability at 18-22 months after neonatal encephalopathy, in LMICs. METHODS: We will randomly allocate 408 term or near-term babies (aged ≤ 6 h) with moderate or severe neonatal encephalopathy admitted to public sector neonatal units in LMIC countries (India, Bangladesh or Sri Lanka), to either usual care alone or whole-body cooling with usual care. Babies allocated to the cooling arm will have core body temperature maintained at 33.5 °C using a servo-controlled cooling device for 72 h, followed by re-warming at 0.5 °C per hour. All babies will have detailed infection screening at the time of recruitment and 3 Telsa cerebral magnetic resonance imaging and spectroscopy at 1-2 weeks after birth. Our primary endpoint is death or moderate or severe disability at the age of 18 months. DISCUSSION: Upon completion, HELIX will be the largest cooling trial in neonatal encephalopathy and will provide a definitive answer regarding the safety and efficacy of cooling therapy for neonatal encephalopathy in LMICs. The trial will also provide important data about the influence of co-existent perinatal infection on the efficacy of hypothermic neuroprotection. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02387385 . Registered on 27 February 2015.