Neonatal Infections Clinical Trial
Official title:
A Randomized Controlled Trial to Evaluate the Acceptability, Feasibility and Efficacy of the Use of a Neonatal Package to Reduce Neonatal Infection in a Rural District of Pakistan
Verified date | June 2016 |
Source | Aga Khan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Pakistan: Ministry of Health |
Study type | Interventional |
Neonatal mortality has been a notable health issue in Pakistan. Considering the importance of the issue and well recognized interventions the investigators are proposing a randomized controlled trial in a rural district of Pakistan which will evaluate the effectiveness of a neonatal package comprised of the standard neonatal care, Kangaroo Mother Care (KMC) and application of chlorhexidine compared with standard neonatal care coupled with application of chlorhexidine and essential neonatal care alone. The investigators anticipate that this study will provide an evidence base way forward benefiting the children of Pakistan.
Status | Completed |
Enrollment | 1450 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 28 Days |
Eligibility |
Inclusion Criteria: - All healthy newborns born in the study settings will be systematically enrolled in the trial after prior consent. Exclusion Criteria: - Infants with congenital/birth defects, - 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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Pakistan | Taluka Hospital KN Shah | Dadu | Sindh |
Lead Sponsor | Collaborator |
---|---|
Aga Khan University | The International Federation of Red Cross and Red Crescent Societies, University of Sydney |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in the Incidence of Neonatal infections in the first 28 days of life (Clinical presence of danger signs as per the IMNCI guidelines.) | Clinical presence of danger signs as per the IMNCI guidelines. | 28 days post recruitment | Yes |
Secondary | Reduction in the Incidence of omphalitis (Redness and Swelling of umbilical stump/cord (Inflammation)) | Redness and Swelling of umbilical stump/cord (Inflammation): | 28 days post recruitment | Yes |
Secondary | Failure to thrive (Weight, length and OFC appropriate for age as per WHO guidelines) | Weight, length and OFC appropriate for age as per WHO guidelines | 28 days post recruitment | Yes |
Secondary | Utilization of KMC Compliance, Frequency and duration | Compliance, Frequency and duration - hours/day | 28 days post recruitment | Yes |
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