Chlorhexidine Cord Care for Newborn Infants in Kenya

NCT02624622 | Terminated

• 1 other identifier: UNM HRRC 14-356
• Study Type: interventional
• Target: 576
• Locations: 1 country
• Sites: 1

Brief Summary

Studies in several countries with a high rate of death of infants during the first week of life have found a reduction in infection and mortality when chlorhexidine is applied to the umbilical cord stump by a health worker within 24 hours of birth. This study will evaluate if providing chlorhexidine to pregnant women during a prenatal care visit for application to the cord stump after birth will be as effective for preventing omphalitis (infection of the umbilical cord stump) as sending a community health worker into the home to apply the chlorhexidine.

Conditions

Omphalitis

Keywords

omphalitis; neonate; developing countries

Outcome Measures

Primary Outcomes (1)

• Number of infants age 0 to 7 days who develop omphalitis

  Omphalitis is defined as redness of the umbilical stump that extends to the skin of the abdomen with or without purulent exudate (pus).

  7 days after birth

Secondary Outcomes (1)

• The average time in minutes from birth to chlorhexidine application (total time for all participants in the arm divided by total participants in the arm).

  7 days

Study Arms (2)

CHW applies chlorhexidine

ACTIVE COMPARATOR

Intervention: Chlorhexidine gel 7.1% topical 3 gm applied to the umbilical cord stump in one application. The community health worker is given the chlorhexidine to apply to the umbilical cord stump within 24 hours of delivery of the newborn infant.

Procedure: Chlorhexidine application by CHW

Mother applies chlorhexidine

EXPERIMENTAL

Intervention: Chlorhexidine gel 7.1% topical 3 gm applied to the umbilical cord stump in one application. Mother is given the chlorhexidine during the first prenatal care visit to apply to the umbilical cord stump within 24 hours of delivery of the newborn infant.

Procedure: Chlorhexidine application to cord by mother

Interventions

Chlorhexidine application to cord by mother PROCEDURE

Mother applies chlorhexidine

Chlorhexidine application by CHW PROCEDURE

CHW applies chlorhexidine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of New Mexico: lead
• University of Nairobi: collaborator

Study Sites (1)

UNM

Albuquerque, New Mexico, 87131, United States

Location

Study Officials

• ANGELO TOMEDI, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 8, 2015
• Study Start: March 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

US (1)