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Topical Application of Chlorhexidine to the Umbilical Cord for Prevention of Omphalitis and Neonatal Mortality in Rural District of Pakistan

This study has been completed.
Sponsor:
Collaborator:
John Snow, Inc.
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00682006
First received: May 19, 2008
Last updated: July 7, 2011
Last verified: July 2009
History of Changes
  Purpose

The investigators hypothesize that application of 4% Chlorhexidine to the cord stump and meticulous hand washing by primary health care providers of newborn infants will reduce the incidence of Omphalitis and thereby Neonatal Mortality as compared to standardized dry cord care.


Condition Intervention Phase
Omphalitis
 Drug: 4% Chlorhexidine
Other: Hand washing Soap
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Topical Application of Chlorhexidine to the Umbilical Cord for Prevention of Omphalitis and Neonatal Mortality in Rural District of Pakistan: A Community-based Randomized Control Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Incidence of Neonatal Omphalitis [ Time Frame: By the end of the styudy ] [ Designated as safety issue: No ]
  • Rate of Neonatal Mortality [ Time Frame: By the end of the Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Breastfeeding rate [ Time Frame: By the end of the Study ] [ Designated as safety issue: No ]
  • Rate of Serious Neonatal Infections [ Time Frame: By the end of the Study ] [ Designated as safety issue: No ]
  • Utilization of Clean Delivery Kits [ Time Frame: By the end of the Study ] [ Designated as safety issue: No ]
  • Application Practice of Chlorhexidine [ Time Frame: By the end of the Study ] [ Designated as safety issue: No ]

Enrollment: 9800
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
In this arm we recruited 2,400 subjects who received Intervention.
 Drug: 4% Chlorhexidine
4% Chlorhexidine was provided to be applied in this arm to Mothers through TBAs.
Experimental: B
In this Arm, we recruited 2,400 subjects who received intervention.
 Other: Hand washing Soap
Hand washing soap was provided to Mothers through TBAs.
Experimental: C
In this Arm, we recruited 2,400 subjects who received intervention.
 Drug: 4% Chlorhexidine
4% Chlorhexidine was provided to be applied by Mothers through TBAs.
No Intervention: D
In this Arm, we recruited 2,400 subjects for Observation and comparison. This was the prime control group.

Detailed Description:

The prime objective of this study is to estimate the independent effect of 4% Chlorhexidine solution application to cord stump and hand washing with soap by mothers of newborns for 2 weeks after birth in reducing Omphalitis in neonates compared to routine cord care by TBAs (Traditional Birth Attendant) in rural district of Sindh, Pakistan.

This study will be conducted in existing health infrastructure in a community setting with the help of two principal health care providers, TBAs and CHWs Community Health Workers) involved in maternal and newborn care. The TBAs conducting delivery wil be trained to wash hands with soap and water after completion of delivery and apply chlorhexidine to the Umbilical Cord Stump. The procedure will be repeated by the mother on the subsequent days up til 14 days from birth. The CHWs will also be trained to recognized signs of Omphalitis and record Cord Care in a systemic manner in a structured proforma.

The study will continue longitudinally for a period of one year to follow newborn for the signs of Omphalitis.

  Eligibility

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All healthy newborns, born in the study setting will be systematically enrolled in the trial

Exclusion Criteria:

  • Infants with congenital/birth defects
  • Infants with any localized infection on the peri-umbilical region at the time of birth or application of any other material such as dung, etc before enrollment on the Cord.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682006

Locations
Pakistan
Proejct Office
Dadu, Sindh, Pakistan, 75300
Sponsors and Collaborators
Aga Khan University
John Snow, Inc.
Investigators
Principal Investigator: Zulfiqar Dr Bhutta, MBBS, PhD, FRCP, MRCP The Aga Khan University
  More Information

No publications provided by Aga Khan University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr Zulfiqar A Bhutta, The Aga Khan University
ClinicalTrials.gov Identifier: NCT00682006     History of Changes
Other Study ID Numbers: 683-Ped/ERC-06
Study First Received: May 19, 2008
Last Updated: July 7, 2011
Health Authority: Pakistan: Ministry of Health

Keywords provided by Aga Khan University:
Omphalitis
4% Chlorhexidine
Newborns

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on May 23, 2013