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

Aga Khan University

Status and phase: Completed; Phase 3

Conditions: Omphalitis

Treatments: Drug: 4% Chlorhexidine; Other: Hand washing Soap

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00682006

683-Ped/ERC-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9,800 patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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9,800 participants in 4 patient groups

A

Experimental group

Description:

In this arm we recruited 2,400 subjects who received Intervention.

Treatment:

Drug: 4% Chlorhexidine

Drug: 4% Chlorhexidine

B

Experimental group

Description:

In this Arm, we recruited 2,400 subjects who received intervention.

Treatment:

Other: Hand washing Soap

C

Experimental group

Description:

In this Arm, we recruited 2,400 subjects who received intervention.

Treatment:

Drug: 4% Chlorhexidine

Drug: 4% Chlorhexidine

D

No Intervention group

Description:

In this Arm, we recruited 2,400 subjects for Observation and comparison. This was the prime control group.