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

Sponsors and Collaborators:	Aga Khan University John Snow Inc. / PAIMAN, Islamabad, Pakistan
Information provided by:	Aga Khan University
ClinicalTrials.gov Identifier:	NCT00682006

Purpose

We hypothesize that application of 4% Chlorhexidine to the cord stump and meticuluous 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 III

Drug Information available for: Chlorhexidine Chlorhexidine digluconate Hibiclens

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	4475
Study Start Date:	January 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental In this arm we will recruit 1,125 subjects who will receive Intervention.	Drug: 4% Chlorhexidine 4% Chlorhexidine will be provided to be applied in this arm to Mothers thorugh TBAs.
B: Experimental In this Arm, we will recruit 1,275 subjects who will receive intervention.	Other: Hand washing Soap Hand washing soap will be provided to Mothers through TBAs.
C: Experimental In this Arm, we will recruit 1,200 subjects who will receive intervention.	Drug: 4% Chlorhexidine 4% Chlorhexidine will be provided to be applied by Mothers through TBAs.
D: No Intervention In this Arm, we will only recruit 1,175 subjects for Observation and comparison. This will be 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

Contacts

Contact: Mir Mr Khan, MBA	92-21-493-0051 ext 4385	asghar.ali@aku.edu
Contact: Naveed Dr Bhutto, MBBS	92-21-493-0051 ext 4385	naveed.bhutto@aku.edu

Locations

Pakistan, Sindh
Proejct Office	Recruiting
Dadu, Sindh, Pakistan, 75300
Contact: Naveed Dr Bhutto, MBBS 92-300-923-2139 ext 0 naveed.bhutto@aku.edu
Contact: Mir Mr Khan, MBA 92-21-493-0051 ext 4385 asghar.ali@aku.edu

Sponsors and Collaborators

Aga Khan University

John Snow Inc. / PAIMAN, Islamabad, Pakistan

Investigators

Principal Investigator:

Zulfiqar Dr Bhutta, MBBS, PhD, FRCP, MRCP

The Aga Khan University

More Information

No publications provided

Responsible Party:	The Aga Khan University ( Dr Zulfiqar A Bhutta )
Study ID Numbers:	683-Ped/ERC-06
Study First Received:	May 19, 2008
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00682006 History of Changes
Health Authority:	Pakistan: Ministry of Health

Keywords provided by Aga Khan University:

Omphalitis
4% Chlorhexidine
Newborns

Study placed in the following topic categories:

Anti-Infective Agents, Local
Disinfectants
Chlorhexidine
Chlorhexidine gluconate

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Infective Agents, Local
Disinfectants
Chlorhexidine

Chlorhexidine gluconate
Therapeutic Uses
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009