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.

IntroductionPreterm infants make up the majority of the 9 million babies born in Africa and South Asia requiring supplemental feedings as they transition to exclusive breastfeeding. The World Health Organization recommends the use of a cup to feed newborns with breastfeeding difficulties in low-resource settings. We set out to evaluate the Nifty cup, a new feeding cup designed specifically for infants with breastfeeding difficulties.Materials and methodsWe conducted a randomized clinical trial in Ghana. We hypothesized infants would prefer the Nifty cup and that it would have less spillage as compared to a medicine cup. We enrolled mothers and preterm infants with breastfeeding difficulties indicated to cup feed at Komfo Anokye Teaching Hospital. Each mother-infant pair used the Nifty cup and a standard medicine cup; and two feeding assessments with each cup were conducted. We employed an intent-to-treat analysis comparing cup preference using a Wilcoxon signed rank test and spillage using generalized estimating equations.ResultsWe enrolled 200 mothers and 237 infants. Many infants were very low birth weight (62%), less than two weeks old (62%), and multiple birth (29%). In response to separate questions about each cup, more mothers reported liking the Nifty cup a lot as compared to the medicine cup (85% versus 57%, p<0.001). When asked to choose between the two cups, more than 75% preferred the Nifty cup (p < 0.001). There was slightly less spillage with the Nifty cup (8.9%) versus the medicine cup (9.3%), which was not statistically significant (p = 0.35). Mothers reported greater confidence and ease of using the Nifty cup and greater use one-month post-discharge compared to the medicine cup (p-values <0.001). Nearly all mothers were breastfeeding and cup feeding their infants at study initiation and at one-month post-discharge.DiscussionThis is the first randomized clinical trial of cup feeding in sub-Saharan Africa. Mothers prefer the Nifty cup to a medicine cup for supplemental feeds to their preterm infant. The Nifty cup was used with greater ease and confidence. The Nifty cup can offer an improved feeding experience for the mother-infant pair.

Background:Preterm birth or low birth weight is the single largest cause of death in newborns, but the 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 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 morbidity, or the immediate KMC will 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 two years of life, and assessing their growth and neurodevelopment. Methods:This prospective cohort study will enroll surviving neonates from the main immediate KMC trial. The main trial as well as this follow-up study are being conducted in five low- and middle-income income countries in South Asia and sub-Saharan Africa. The sample size for comparison of risk of neurodevelopmental impairment is a total of about 2200 neonates. The primary outcomes will include rates of cerebral palsy, hearing impairment, vision impairment, mental and motor development, and epilepsy and will be assessed by the age of three years. The analysis will be by intention to treat.DiscussionImmediate 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, therefore, help in evaluating the overall impact of KMC by investigating the long-term effect on neurodevelopmental impairment in the survivors.Trial registrationClinical Trials Registry-India: CTRI/2019/11/021899 on 06 November 2019

Background: Decreasing infant mortality was a key aim of Millennium Development Goal (MDG) 4. While many regions worldwide made substantial progress, not all attained MDG4. Defining determinants of infant mortality in settings with high rates of infant mortality can inform strategies to further decrease mortality.Methods: Data were analyzed from the Mama Salama Study (MSS), a prospective peripartum cohort study in Western Kenya examining HIV acquisition in pregnancy to 9 months postpartum between 2011 and 2014. Cases of infant death were compared to control infants who survived to 9 months postpartum. Sub-analyses compared neonatal and perinatal mortality cases to controls. Logistic regression was used to identify determinants of infant, neonatal, and perinatal mortality using StataÒ 13 software.Findings: In multivariate case-control comparison of 34 infant deaths and 1053 control infants, independent correlates of infant mortality were preterm delivery (aOR¼3.49, 95% CI 1.68-7.26), twin delivery (aOR¼4.63, 95% CI 1.22-17.55), travel time to clinic greater than 1 hour (aOR¼2.66, 95% CI 1.04-6.84), maternal malaria during pregnancy (aOR¼3.52, 95% CI 1.40-8.86), and maternal chlamydia infection during pregnancy (aOR¼3.76, 95% CI 1.37-10.30). Maternal chlamydia infection was also an independent determinant of neonatal mortality (aOR¼9.56, 95% CI 2.49-36.64).Interpretation: Improved services to detect, treat and prevent maternal and infant chlamydia and malaria, and vigilance in the care of preterm and twin deliveries may decrease infant mortality in high mortality regions.