title: Trial of improved practices approach to explore the acceptability and feasibility of different modes of chlorhexidine application for neonatal cord care in Pemba, Tanzania.
abstract: BACKGROUND
  Infections are responsible for 30-40 % of 4 million neonatal deaths annually. Use of chlorhexidine (CHX), a broad-spectrum topical antiseptic with strong residual activity, for umbilical cord cleansing has been shown to reduce infections during the neonatal period. However, the challenge remains with regard to selection of best mode of CHX delivery. As a part of formative research, we undertook a qualitative study in Pemba Island as a pilot to explore the attitudes; beliefs and practices of the community and health workers related to delivery, newborn and cord care. During the second phase of formative research, we used Trials of Improved Practices (TIPs) methodology to explore the acceptance and impediments, for the three possible modes of chlorhexidine application- 100 ml bottle with cotton swab, 10 ml single use dropper bottle and 3 g single application squeeze tube containing gel, as an umbilical cord care intervention.
  
  
  METHODS
  In this pilot study, 204 mother-newborn pairs were enrolled from hospital and community setting in Pemba, Tanzania using a randomized three period crossover design. Mothers/guardians, Trained Birth Attendants (TBA)/ medical staff and community health workers (CHWs) were requested to try three different modes of CHX application for cord cleaning. All participants were demonstrated the method of cord cleaning using all three modes of delivery; each delivery mode was used for 3 days and an interview was conducted on day 10 to collect summary of their experience. Acceptance and preference scores were calculated based on feedback from the participants.
  
  
  RESULTS
  Of 204 mother-newborn pairs, 27 were lost to follow up. 177 mothers performed the intervention and applied CHX to the newborn cord for all 9 days. Mothers rated 10 ml dropper bottle (49.7 %) as most convenient in terms of ease and application. They selected 10 ml dropper bottle (44.6 %) as their first choice; gel tube (33.9 %) and 100 ml bottle (21.5 %) as their second and third choice. TBAs, medical staff and CHWs also preferred 10 ml dropper bottle (43.3 %) over 100 ml bottle (12.9 %) and gel (38.8 %).
  
  
  CONCLUSIONS
  Overall acceptability of CHX application for cord cleansing was high. 10 ml single use dropper bottle was given highest preference for CHX application. An understanding of the attitudes, beliefs and cultural practices in the community and selection of the most acceptable mode of CHX delivery is essential to the design and implementation of the intervention trials examining the efficacy of CHX cord care in reducing neonatal mortality and subsequent implementation in the programs.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01528852 Registered February 3, 2012.
authors.affiliation: Department of International Health, E5521, Johns Hopkins Bloomberg School of Public Health, 615, North Wolfe Street, Baltimore, MD, 21205-203, USA. udhingra@jhsph.edu.|Center for Public Health Kinetics, New Delhi, India. udhingra@jhsph.edu.
authors.forename: Usha
authors.initials: U
authors.lastname: Dhingra
authors.affiliation: Department of International Health, E5521, Johns Hopkins Bloomberg School of Public Health, 615, North Wolfe Street, Baltimore, MD, 21205-203, USA. ssazawal@jhu.edu.|Center for Public Health Kinetics, New Delhi, India. ssazawal@jhu.edu.
authors.forename: Sunil
authors.initials: S
authors.lastname: Sazawal
authors.affiliation: Center for Public Health Kinetics, New Delhi, India. pdhingra@cphealthkinetics.in.
authors.forename: Pratibha
authors.initials: P
authors.lastname: Dhingra
authors.affiliation: Public Health Laboratory-Ivo de Carneri, Wawi, Chake-Chake, Pemba, Zanzibar, Tanzania. adutta@cphealthkinetics.org.
authors.forename: Arup
authors.initials: A
authors.lastname: Dutta
authors.affiliation: Public Health Laboratory-Ivo de Carneri, Wawi, Chake-Chake, Pemba, Zanzibar, Tanzania. saidmali2003@yahoo.com.
authors.forename: Said Mohammed
authors.initials: SM
authors.lastname: Ali
authors.affiliation: Public Health Laboratory-Ivo de Carneri, Wawi, Chake-Chake, Pemba, Zanzibar, Tanzania. shaaliame@yahoo.com.
authors.forename: Shaali Makame
authors.initials: SM
authors.lastname: Ame
authors.affiliation: Public Health Laboratory-Ivo de Carneri, Wawi, Chake-Chake, Pemba, Zanzibar, Tanzania. saikatdeb@gmail.com.
authors.forename: Saikat
authors.initials: S
authors.lastname: Deb
authors.affiliation: Public Health Laboratory-Ivo de Carneri, Wawi, Chake-Chake, Pemba, Zanzibar, Tanzania. atifasule@yahoo.com.
authors.forename: Atifa Mohammed
authors.initials: AM
authors.lastname: Suleiman
authors.affiliation: Department of International Health, E5521, Johns Hopkins Bloomberg School of Public Health, 615, North Wolfe Street, Baltimore, MD, 21205-203, USA. rblack1@jhu.edu.
authors.forename: Robert E
authors.initials: RE
authors.lastname: Black
mesh_terms: D000891:Anti-Infective Agents, Local / Q000627:therapeutic use*; D002710:Chlorhexidine / Q000627:therapeutic use*; D036861:Delivery, Obstetric; D005260:Female; D006801:Humans; D007223:Infant; D007226:Infant Mortality; D007231:Infant, Newborn; D010342:Patient Acceptance of Health Care; D010865:Pilot Projects; D011247:Pregnancy; D036301:Qualitative Research; D018805:Sepsis / Q000188:drug therapy*; D013636:Tanzania; D014470:Umbilical Cord
chemical_list: D000891:Anti-Infective Agents, Local; D002710:Chlorhexidine