TY - JOUR
T1 - Trial of improved practices approach to explore the acceptability and feasibility of different modes of chlorhexidine application for neonatal cord care in Pemba, Tanzania
AU - Dhingra, Usha
AU - Sazawal, Sunil
AU - Dhingra, Pratibha
AU - Dutta, Arup
AU - Ali, Said Mohammed
AU - Ame, Shaali Makame
AU - Deb, Saikat
AU - Suleiman, Atifa Mohammed
AU - Black, Robert E.
N1 - Funding Information:
This study was supported by the Bill & Melinda Gates Foundation. We are grateful to the mothers, TBAs, MCH and hospital staff for their participation, time and co-operation. We also thank the Ministry of Health, Government of Zanzibar, Tanzania, for providing guidance and physical support at every stage of the study; The Public Health Laboratory-Ivo de Carneri, as a collaborating institution, for contributing towards management and community relations, and providing infrastructural support. We duly acknowledge the contribution of Galentic Pharma (India) Pvt. Ltd for providing chlorhexidine and ensuring delivery on time. We further certify that neither the funding agency nor the pharmaceutical company had any role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Publisher Copyright:
© 2015 Dhingra et al.
PY - 2015/12/28
Y1 - 2015/12/28
N2 - 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. Trial registration: ClinicalTrials.gov NCT01528852Registered February 3, 2012
AB - 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. Trial registration: ClinicalTrials.gov NCT01528852Registered February 3, 2012
KW - Chlorhexidine
KW - Cord care
KW - Trials of Improved Practices (TIPs)
UR - http://www.scopus.com/inward/record.url?scp=84951749235&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84951749235&partnerID=8YFLogxK
U2 - 10.1186/s12884-015-0760-4
DO - 10.1186/s12884-015-0760-4
M3 - Article
C2 - 26711437
AN - SCOPUS:84951749235
VL - 15
JO - BMC Pregnancy and Childbirth
JF - BMC Pregnancy and Childbirth
SN - 1471-2393
IS - 1
M1 - 354
ER -