Evidence map›Paper›PMID 26711437›Full record

Trial reportBMC pregnancy and childbirth2015

Trial of improved practices approach to explore the acceptability and feasibility of different modes of chlorhexidine application for neonatal cord care in Pemba, Tanzania.

Usha Dhingra, Sunil Sazawal, Pratibha Dhingra, Arup Dutta, Said Mohammed Ali, Shaali Makame Ame, Saikat Deb, Atifa Mohammed Suleiman, Robert E Black

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC pregnancy and childbirth, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01528852 (Efficacy of Use of Chlorhexidine to Clean Umbilical Cord of Neonates in First 10 Days for Reduction in Neonatal Mortality and Omphalitis - A Community Based Randomized, Double Masked Controlled Trial in Pemba Tanzania), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01528852 phase3completednot on this map

Efficacy of Use of Chlorhexidine to Clean Umbilical Cord of Neonates in First 10 Days for Reduction in Neonatal Mortality and Omphalitis - A Community Based Randomized, Double Masked Controlled Trial in Pemba Tanzania

TypeinterventionalSponsorJohns Hopkins Bloomberg School of Public HealthRan2011 to 2014Enrolled36,911ConditionsNeonatal Mortality, Cord Care, OmphalitisArmsChlorhexidine 4%, Control cord cleaning solution
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Usha DhingraDepartment of International Health, E5521, Johns Hopkins Bloomberg School of Public Health, 615, North Wolfe Street, Baltimore, MD, 21205-203, USA. udhingra@jhsph.edu.
Sunil SazawalDepartment of International Health, E5521, Johns Hopkins Bloomberg School of Public Health, 615, North Wolfe Street, Baltimore, MD, 21205-203, USA. ssazawal@jhu.edu.
Pratibha DhingraCenter for Public Health Kinetics, New Delhi, India. pdhingra@cphealthkinetics.in.
Arup DuttaPublic Health Laboratory-Ivo de Carneri, Wawi, Chake-Chake, Pemba, Zanzibar, Tanzania. adutta@cphealthkinetics.org.
Said Mohammed AliPublic Health Laboratory-Ivo de Carneri, Wawi, Chake-Chake, Pemba, Zanzibar, Tanzania. saidmali2003@yahoo.com.
Shaali Makame AmePublic Health Laboratory-Ivo de Carneri, Wawi, Chake-Chake, Pemba, Zanzibar, Tanzania. shaaliame@yahoo.com.
Saikat DebPublic Health Laboratory-Ivo de Carneri, Wawi, Chake-Chake, Pemba, Zanzibar, Tanzania. saikatdeb@gmail.com.
Atifa Mohammed SuleimanPublic Health Laboratory-Ivo de Carneri, Wawi, Chake-Chake, Pemba, Zanzibar, Tanzania. atifasule@yahoo.com.
Robert E BlackDepartment of International Health, E5521, Johns Hopkins Bloomberg School of Public Health, 615, North Wolfe Street, Baltimore, MD, 21205-203, USA. rblack1@jhu.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInfections 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.

methodsIn 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.

resultsOf 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 %).

conclusionsOverall 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 registrationClinicalTrials.gov NCT01528852 Registered February 3, 2012.

Indexed as

Infant MortalityUmbilical CordAnti-Infective Agents, LocalChlorhexidineDelivery, ObstetricFemaleHumansInfantInfant, NewbornPatient Acceptance of Health CarePilot ProjectsPregnancyQualitative ResearchSepsisTanzaniaAnti-Infective Agents, LocalChlorhexidine

Identifiers

PMID26711437
PMCPMC4693417

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.