NCT01528852

Brief Summary

In a community-based controlled trial among children to evaluate if use of 4% Chlorhexidine cleansing solution on umbilical cord of infants in first 10 days of life results in

  • Reduction in neonatal mortality (deaths in first 28 days of life)
  • Reduction in umbilical cord infections (defined by moderate or severe redness of the cord) during first 28 days of life
  • Reduction in umbilical cord infections (defined by pus formation with any degree of redness) during first 28 days of life. The double blind part of study uses a control preparation without chlorhexidine (CHX) as control group while in the sub-study dry cord care group is also evaluated as second control. Hypothesis is that CHX group will have lower mortality and umbilical cord infections while control group and dry cord group will be similar as shown in a previous study in Nepal.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36,911

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2011

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 19, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2014

Completed
Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

3.4 years

First QC Date

February 3, 2012

Last Update Submit

August 24, 2023

Conditions

Neonatal MortalityCord CareOmphalitis

Keywords

neonatal Mortalitychlorhexidine cord carecord infectionsafrican settingsclinical trials

Outcome Measures

Primary Outcomes (1)

  • Neonatal Mortality

    28 days after birth

Secondary Outcomes (1)

  • Omphalitis

    Birth to 28 days of life

Study Arms (3)

CHX Cord application

EXPERIMENTAL

Chlorhexidine cord application for 10 days

Drug: Chlorhexidine 4%

Control

ACTIVE COMPARATOR

Same liquid as intervention without the chlorhexidine used for cord cleaning for 10 days once daily

Other: Control cord cleaning solution

Dry Cord care

NO INTERVENTION

Use current recommended keep cord dry

Interventions

Chlorhexidine 4%DRUG

4% liquid solution used for cord cleaning once daily for 10 days

CHX Cord application
Control cord cleaning solutionOTHER

Mild soapy solution used to clean cord once daily for 10 days

Control

Eligibility Criteria

Age1 Hour - 48 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Permanent resident of Pemba
  • Consenting to participate, infants alive at first contact with MCH/TBA/Hospital staff
  • First contact within 48 hours of delivery.

You may not qualify if:

  • Congenital malformations where application of intervention is not possible
  • Very sick child needing hospitalization and ICU care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PHL-IDC

Pemba, Zanzibar, Tanzania

Location

Related Publications (4)

  • Sazawal S, Dhingra U, Ali SM, Dutta A, Deb S, Ame SM, Mkasha MH, Yadav A, Black RE. Efficacy of chlorhexidine application to umbilical cord on neonatal mortality in Pemba, Tanzania: a community-based randomised controlled trial. Lancet Glob Health. 2016 Nov;4(11):e837-e844. doi: 10.1016/S2214-109X(16)30223-6. Epub 2016 Sep 29.

    PMID: 27693438RESULT

  • Nangia S, Dhingra U, Dhingra P, Dutta A, Menon VP, Black RE, Sazawal S. Effect of 4 % chlorhexidine on cord colonization among hospital and community births in India: a randomized controlled study. BMC Pediatr. 2016 Aug 2;16:121. doi: 10.1186/s12887-016-0625-7.

    PMID: 27484013DERIVED

  • Dhingra U, Sazawal S, Dhingra P, Dutta A, Ali SM, Ame SM, Deb S, Suleiman AM, Black RE. Trial of improved practices approach to explore the acceptability and feasibility of different modes of chlorhexidine application for neonatal cord care in Pemba, Tanzania. BMC Pregnancy Childbirth. 2015 Dec 28;15:354. doi: 10.1186/s12884-015-0760-4.

    PMID: 26711437DERIVED

  • Dhingra U, Gittelsohn J, Suleiman AM, Suleiman SM, Dutta A, Ali SM, Gupta S, Black RE, Sazawal S. Delivery, immediate newborn and cord care practices in Pemba Tanzania: a qualitative study of community, hospital staff and community level care providers for knowledge, attitudes, belief systems and practices. BMC Pregnancy Childbirth. 2014 May 22;14:173. doi: 10.1186/1471-2393-14-173.

    PMID: 24885689DERIVED

Related Links

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2012

First Posted

February 8, 2012

Study Start

May 19, 2011

Primary Completion

September 29, 2014

Study Completion

September 29, 2014

Last Updated

August 28, 2023

Record last verified: 2023-08

Locations

TA(1)