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.

Serum Micronutrient Status of Haart-Naïve, HIV Infected Children in South Western Nigeria: A Case Controlled Study.

Background. Though micronutrients are vital in the pathogenesis of human immunodeficiency virus infection, most studies have been conducted in adults. Knowledge of the status of key micronutrients in HIV infected African children will indicate if supplementation may be beneficial to these children living in this resource-poor region. Objectives. We sought to determine the micronutrient status and associated factors of HAART-naïve HIV infected children and compare them with those of the HIV negative controls. Methods. We enrolled 70 apparently stable HAART naïve HIV infected children. Seventy age and sex matched HIV negative children were equally enrolled as the controls. Their social class, anthropometry, clinical stage, CD4 counts, serum zinc, selenium, and vitamin C were determined. Results. The prevalence of zinc, selenium, and vitamin C deficiency in HIV infected subjects was 77.1%, 71.4%, and 70.0%, respectively, as compared to 44.3%, 18.6%, and 15.7% in HIV negative controls. Among the HIV infected subjects, 58.6% were deficient in the three micronutrients. Micronutrient status was related to the weight, clinical, and immunological stages but not BMI or social class. Conclusion. Deficiency of these key micronutrients is widely prevalent in HAART naïve HIV infected children irrespective of social class. This suggests that supplementation trial studies may be indicated in this population.