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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00682006
Other study ID # 683-Ped/ERC-06
Secondary ID
Status Completed
Phase Phase 3
First received May 19, 2008
Last updated July 7, 2011
Start date January 2008
Est. completion date December 2009

Study information

Verified date July 2009
Source Aga Khan University
Contact n/a
Is FDA regulated No
Health authority Pakistan: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 9800
Est. completion date December 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group N/A to 28 Days
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
4% Chlorhexidine
4% Chlorhexidine was provided to be applied in this arm to Mothers through TBAs.
Other:
Hand washing Soap
Hand washing soap was provided to Mothers through TBAs.
Drug:
4% Chlorhexidine
4% Chlorhexidine was provided to be applied by Mothers through TBAs.

Locations

Country Name City State
Pakistan Proejct Office Dadu Sindh

Sponsors (2)

Lead Sponsor Collaborator
Aga Khan University John Snow, Inc.

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Neonatal Omphalitis By the end of the styudy No
Primary Rate of Neonatal Mortality By the end of the Study No
Secondary Breastfeeding rate By the end of the Study No
Secondary Rate of Serious Neonatal Infections By the end of the Study No
Secondary Utilization of Clean Delivery Kits By the end of the Study No
Secondary Application Practice of Chlorhexidine By the end of the Study No
See also
  Status Clinical Trial Phase
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Completed NCT06002295 - A Comparative Analysis of 4% Chlorhexidine Versus Methylated Spirit as Prophylaxis of Omphalitis and Sepsis in Newborns Phase 2
Completed NCT01751945 - Improved Accessibility of EmONC Services for Maternal and Newborn Health: a Community Based Project N/A
Completed NCT00434408 - Impact of Umbilical Cord Cleansing With 4.0% Chlorhexidine on Neonatal Mortality Phase 3
Completed NCT01528852 - Chlorhexidine Cordcare for Reduction in Neonatal Mortality and Omphalitis Phase 3
Terminated NCT02624622 - Chlorhexidine Cord Care for Newborn Infants in Kenya N/A
Terminated NCT01556867 - Evaluation of Two Strategies for Umbilical Cord Care : Dry Cord Care Versus Antiseptic on the Incidence of Omphalitis in Healthy Term Newborn N/A
Recruiting NCT04798833 - Newborn Care Kit to Save Lives in GB, Pakistan N/A
Completed NCT02694679 - Randomized Controlled Trial of Social Network Targeting in Honduras N/A
Recruiting NCT02606565 - Efficacy of Umbilical Cord Cleansing With a Single Application of 4% Chlorhexidine for the Prevention of Newborn Infections in Uganda: a Randomized Controlled Trial Phase 4