Neonatal emollient therapy and massage practices in Africa: a scoping review.

There have been few reports from Africa on the use and health effects of emollient therapy for newborn infants. We aimed to describe neonatal skin care practices in Africa, and to illuminate opportunities to introduce evidence-based interventions to improve these practices. We conducted a scoping review of the quantitative and qualitative published peer-reviewed and grey literature in English on emollient use in Africa. Outcomes of interest included neonatal skin care practices, with a focus on the application of oils and other products to infant skin, including in association with bathing and massage. We screened 5257 articles and summarised findings from 23 studies-13 qualitative, nine quantitative and one mixed methods-that met our study criteria. Seven studies reported the use of emollients for perceived benefits, including thermal care, treatment for illness, promotion of growth and development, infection reduction, skin condition improvement, spirituality and lubrication to aid massage. Four studies reported the quantitative health impact of skin care product applications, including improvements in skin condition, neurodevelopment and bone growth, as well as a reduction in nosocomial infections. This review highlights opportunities for skin care intervention and future research on neonatal skin care practices in Africa.

Effects of emollient therapy with sunflower seed oil on neonatal growth and morbidity in Uttar Pradesh, India: a cluster-randomized, open-label, controlled trial.

BACKGROUND: Newborn oil massage is a widespread practice. Vigorous massage with potentially harmful products and forced removal of vernix may disrupt skin barrier integrity. Hospitalized, very-preterm infants treated with sunflower seed oil (SSO) have demonstrated improved growth but community-based data on growth and health outcomes are lacking. OBJECTIVES: We aimed to test whether SSO therapy enhances neonatal growth and reduces morbidity at the population level. METHODS: We conducted an open-label, controlled trial in rural Uttar Pradesh, India, randomly allocating 276 village clusters equally to comparison (usual care) and intervention comprised of promotion of improved massage practices exclusively with SSO, using intention-to-treat and per-protocol mixed-effects regression analysis. RESULTS: We enrolled 13,478 and 13,109 newborn infants in demographically similar intervention and comparison arms, respectively. Adherence to exclusive SSO increased from 22.6% of intervention infants enrolled in the first study quartile to 37.2% in the last quartile. Intervention infants gained significantly more weight, by 0.94 g · kg-1 · d-1 (95% CI: 0.07, 1.82 g · kg-1 · d-1, P = 0.03), than comparison infants by intention-to-treat analysis. Restricted cubic spline regression revealed the largest benefits in weight gain (2-4 g · kg-1 · d-1) occurred in infants weighing <2000 g at birth. Weight gain in intervention infants was higher by 1.31 g · kg-1 · d-1 (95% CI: 0.17, 2.46 g · kg-1 · d-1; P = 0.02) by per-protocol analysis. Morbidities were similar by intention-to-treat analysis but in per-protocol analysis rates of hospitalization and of any illness were reduced by 36% (OR: 0.64; 95% CI: 0.44, 0.94; P = 0.02) and 44% (OR: 0.56; 95% CI: 0.40, 0.77; P < 0.001), respectively, in treated infants. CONCLUSIONS: SSO therapy improved neonatal growth, and reduced morbidities when applied exclusively, across the facility-community continuum of care at the population level. Further research is needed to improve demand for recommended therapy inside hospital as well as in community settings, and to confirm these results in other settings.This trial was registered at www.isrctn.com as ISRCTN38965585 and http://ctri.nic.in as CTRI/2014/12/005282.

Quantitative decision making for investment in global health intervention trials: Case study of the NEWBORN study on emollient therapy in preterm infants in Kenya.

Background: Partners from an NGO, academia, industry and government applied a tool originating in the private sector - Quantitative Decision Making (QDM) - to rigorously assess whether to invest in testing a global health intervention. The proposed NEWBORN study was designed to assess whether topical emollient therapy with sunflower seed oil in infants with very low birthweight <1500 g in Kenya would result in a significant reduction in neonatal mortality compared to standard of care. Methods: The QDM process consisted of prior elicitation, modelling of prior distributions, and simulations to assess Probability of Success (PoS) via assurance calculations. Expert opinion was elicited on the probability that emollient therapy with sunflower seed oil will have any measurable benefit on neonatal mortality based on available evidence. The distribution of effect sizes was modelled and trial data simulated using Statistical Analysis System to obtain the overall assurance which represents the PoS for the planned study. A decision-making framework was then applied to characterise the ability of the study to meet pre-selected decision-making endpoints. Results: There was a 47% chance of a positive outcome (defined as a significant relative reduction in mortality of ≥15%), a 45% chance of a negative outcome (defined as a significant relative reduction in mortality <10%), and an 8% chance of ending in the consider zone (ie, a mortality reduction of 10 to <15%) for infants <1500 g. Conclusions: QDM is a novel tool from industry which has utility for prioritisation of investments in global health, complementing existing tools [eg, Child Health and Nutrition Research Initiative]. Results from application of QDM to the NEWBORN study suggests that it has a high probability of producing clear results. Findings encourage future formation of public-private partnerships for health.

Protocol for a scoping review of neonatal emollient therapy and massage practices throughout sub-Saharan Africa.

Background: Serious infections and other complications from very low birth weight and prematurity are the leading causes of death for neonates worldwide. Infections partly result from the compromised skin barrier function in preterm neonates. Optimal skin care practices for neonates, especially in settings with limited access to adequate hygienic conditions, hold potential to reduce infection and avoid these preventable preterm neonatal deaths. The purpose of this protocol is to support a scoping review of neonatal skin care, emollient therapy and massage practices throughout sub-Saharan Africa. Protocol: The proposed review will follow a methodological framework consisting of the following five steps: (i) identifying the research question, (ii) identifying relevant studies, (iii) selection of eligible studies, (iv) charting the data, and (v) collating and summarizing the results. In addition, we will reflect on the implications of the findings for the feasibility and design of randomized controlled trials to examine the impact of emollient therapy on survival, growth, infection and neurodevelopment of very low birth weight infants in sub-Saharan Africa. We will search domestic and international databases for literature published in English between January 1, 2000, and July 12, 2021. Articles will be chosen based on standardized inclusion criteria. The primary criteria for inclusion will be a report on skin care practices administered to neonates in Africa. Conclusions: Documentation of common neonatal skin care practices throughout Africa has the potential to highlight opportunities for skin care intervention and future research on neonatal skin care practices in sub-Saharan Africa, and support the development of future emollient intervention trials for preterm and low birthweight neonates in low- and middle-income countries.