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Completed

NCT Number: NCT00682006

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

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.

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Key information

Conditions

Omphalitis

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Proejct Office

Dadu, Sindh, 75300, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

4% Chlorhexidine

Drug

4% Chlorhexidine was provided to be applied in this arm to Mothers through TBAs.

Hand washing Soap

Other

Hand washing soap was provided to Mothers through TBAs.

Primary outcomes

  1. Incidence of Neonatal Omphalitis

    Time frame: By the end of the styudy

  2. Rate of Neonatal Mortality

    Time frame: By the end of the Study

Secondary outcomes

  1. Breastfeeding rate

    Time frame: By the end of the Study

  2. Rate of Serious Neonatal Infections

    Time frame: By the end of the Study

  3. Utilization of Clean Delivery Kits

    Time frame: By the end of the Study

  4. Application Practice of Chlorhexidine

    Time frame: By the end of the Study

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Collaborators

  • John Snow, Inc.

Registry information

Official study 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

Acronym: Chlorhexidine

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 21, 2008
Registry last updated
Jul 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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