Exploratory study to guide the design of an emollients trial in Africa


mother and baby
Duration

18 months

Start Date

January 2011

Funder

Bill & Melinda Gates Foundation

Contact

Study Coordinator

This study, conducted in four African sites, will collect data to inform the design of a community based trial to evaluate whether massaging babies with emollients can reduce neonatal deaths.

Emollients

Emollients are substances that soften and soothe the skin such as oils and moisturisers. Skin can serve as an important entry point for infections and applying emollients to improve skin function is a potentially effective and affordable means of reducing newborn infections. Hospital trials have already shown that emollient use can reduce newborn infections and mortality in pre-term babies. (1-3)

Evidence is lacking about the effectivness of emollients on newborn infections in community settings and on full-term babies. The skin function of full-term babies may be compromised by maternal malnutrition during pregnancy. Home environments may also contain high levels of pathogens and family practices such as the removal of the Vernix, the application of contaminated substances to the skin and poor hand washing may increase infection risks. Community-based emollient trials are needed to establish if the positive results observed in hospitals can also be achieved in the home environment.

A community based trial is being conducted in rural India to evaluate the impact of improved oil and/or improved skin care practices on neonatal mortality


References
1.Darmstadt GL, Saha SK, Ahmed AS, et al. Effect of topical treatment with skin barrier-enhancing emollients on nosocomial infections in preterm infants in Bangladesh: a randomised controlled trial. Lancet. 2005;365(9464):1039-45.

2.Darmstadt GL, Saha SK, Ahmed AS, et al. Effect of skin barrier therapy on neonatal mortality rates in preterm infants in Bangladesh: a randomized, controlled, clinical trial. Pediatrics. 2008; 121(3):522-9.

3.Darmstadt GL, Badrawi N, Law PA, et al.Topically applied sunflower seed oil prevents invasive bacterial infections in preterm infants in Egypt: a randomized, controlled clinical trial. Pediatr Infect Dis J. 2004; 23(8):719-25.

Mother and Baby

This study, funded by the Bill & Melinda Gates Foundation, will collect data to inform the design of a community based trial to evaluate whether massaging babies with emollients can reduce neonatal deaths. For this trial to be feasible, acceptable, scalable and appropriately targetted, it must be based on an understanding of the local context. The study will review available literature and use qualitative and quantitative research methods to understand current skin care and massage practices, the acceptability of emollient use and potential distribution channels for any future product. The impact of commonly used emollients on skin integrity and function will also be explored as not all emollients are beneficial. (1)

The study team will develop recommendations on how and where to test whether emollient therapy can reduce newborn mortality in Africa.


References:

1. Darmstadt GL, Mao-Qiang M, Chi E, et al. Impact of topical oils on the skin barrier: possible implications for neonatal health in developing countries. Acta Paediatr. 2002;91(5):546-54.

Map of Africa with Study Sites shaded in Yellow

In order to understand the range of behaviours and contexts related to emollient use and skin care in Africa, formative research is required in a range of countries. The study will be conducted in four African sites with high neonatal mortality and varied cultural, socio-demographic and health system characteristics.
These sites are shown on the map and listed below

  • Borno state in (North East) Nigeria
  • Ekiti state in (South West) Nigeria
  • West Arsi zone in Ethiopia
  • Lindi and Mtwara districts in Tanzania

The collaborators on this study form an experienced and multi-disciplinary team from:

Logos of Study Partners