Evaluation of the impact of continuous Kangaroo Mother Care (KMC) initiated immediately after birth compared to KMC initiated after stabilization in newborns with birth weight 1.0 to < 1.8 kg on neurodevelopmental outcomes: Protocol for a follow-up study.

BACKGROUND: Preterm birth or low birth weight is the single largest cause of death in newborns, however this mortality can be reduced through newborn care interventions, including Kangaroo Mother Care (KMC). Previously, a multi-country randomized controlled trial, coordinated by the World Health Organization (WHO), reported a significant survival advantage with initiation of continuous KMC immediately after birth compared with initiation of continuous KMC a few days after birth when the baby is considered clinically stable. Whether the survival advantage would lead to higher rates of neurodevelopmental morbidities, or the immediate KMC will also have a beneficial effect on cognitive development also, has not been investigated. We therefore propose to test the hypothesis that low-birth-weight infants exposed to immediate KMC will have lower rates of neurodevelopmental impairment in comparison to traditional KMC-treated infants, by prospectively following up infants already enrolled in the immediate KMC trial for the first 2 years of life, and assessing their growth and neurodevelopment. METHODS: This prospective cohort study will enroll surviving neonates from the main WHO immediate KMC trial. The main trial as well as this follow-up study are being conducted in five low- and middle-income countries in South Asia and sub-Saharan Africa. The estimated sample size for comparison of the risk of neurodevelopmental impairment is a total of 2200 children. The primary outcome will include rates of cerebral palsy, hearing impairment, vision impairment, mental and motor development, and epilepsy and will be assessed by the age of 3 years. The analysis will be by intention to treat. DISCUSSION: Immediate KMC can potentially reduce low-birth-weight-associated complications such as respiratory disease, hypothermia, hypoglycemia, and infection that can result in impaired neurocognitive development. Neuroprotection may also be mediated by improved physiological stabilization that may lead to better maturation of neural pathways, reduced risk of hypoxia, positive parental impact, improved sleep cycles, and improved stress responses. The present study will help in evaluating the overall impact of KMC by investigating the long-term effect on neurodevelopmental impairment in the survivors. TRIAL REGISTRATION: Clinical Trials Registry-India CTRI/2019/11/021899. Registered on 06 November 2019. Trials registration of parent trial: ACTRN12618001880235; Clinical Trials Registry-India: CTRI/2018/08/015369.

Development of multi-disciplinary breast cancer care in Southern Malawi.

The Edinburgh Malawi Breast Cancer Project, a collaborative partnership project between the Queen Elizabeth Central Hospital (QECH) Oncology Unit, Blantyre, Malawi and the Edinburgh Cancer Centre, UK, was established in 2015. The principal objective of the project is to help to develop high quality multi-disciplinary breast cancer care in Malawi. A needs assessment identified three priority areas for further improvement of breast cancer services: multi-disciplinary working, development of oestrogen receptor (ER) testing and management of clinical data. A 3-year project plan was implemented which has been conducted through a series of reciprocal training visits. Key achievements to date have been: (1) Development of a new specialist breast care nursing role; (2) Development of multi-disciplinary meetings; (3) Completion of a programme of oncology nursing education; (4) Development of a clinical database that enables prospective collection of data of all new patients with breast cancer; (5) Training of local staff in molecular and conventional approaches to ER testing. The Edinburgh Malawi Breast Cancer Project is supporting nursing education, data use and cross-specialty collaboration that we are confident will improve cancer care in Malawi. Future work will include the development of a breast cancer diagnostic clinic and a breast cancer registry.