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

May 19, 2008
July 7, 2011
January 2008
September 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00682006 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Topical Application of Chlorhexidine to the Umbilical Cord for Prevention of Omphalitis and Neonatal Mortality in Rural District of Pakistan
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Omphalitis
  • 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.
  • Experimental: A
    In this arm we recruited 2,400 subjects who received Intervention.
    Intervention: Drug: 4% Chlorhexidine
  • Experimental: B
    In this Arm, we recruited 2,400 subjects who received intervention.
    Intervention: Other: Hand washing Soap
  • Experimental: C
    In this Arm, we recruited 2,400 subjects who received intervention.
    Intervention: Drug: 4% Chlorhexidine
  • No Intervention: D
    In this Arm, we recruited 2,400 subjects for Observation and comparison. This was the prime control group.
Soofi S, Cousens S, Imdad A, Bhutto N, Ali N, Bhutta ZA. Topical application of chlorhexidine to neonatal umbilical cords for prevention of omphalitis and neonatal mortality in a rural district of Pakistan: a community-based, cluster-randomised trial. Lancet. 2012 Mar 17;379(9820):1029-36. doi: 10.1016/S0140-6736(11)61877-1. Epub 2012 Feb 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9800
December 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
up to 28 Days
No
Contact information is only displayed when the study is recruiting subjects
Pakistan
 
NCT00682006
683-Ped/ERC-06
No
Dr Zulfiqar A Bhutta, The Aga Khan University
Aga Khan University
John Snow, Inc.
Principal Investigator: Zulfiqar Dr Bhutta, MBBS, PhD, FRCP, MRCP The Aga Khan University
Aga Khan University
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP