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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 June 2016 |
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Main ID: |
NCT02279381 |
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Date of registration:
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28/10/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Neonatal Package Study in Rural District of Pakistan
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Scientific title:
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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 |
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Date of first enrolment:
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November 2014 |
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Target sample size:
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1450 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02279381 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Muhammad Atif Habib, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Aga Khan University |
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
28 Days
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neonatal Infections
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Intervention(s)
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Other: Essential Neonatal Care
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Other: Kangaroo Mother Care
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Drug: Chlorhexidine
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Primary Outcome(s)
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Reduction in the Incidence of Neonatal infections in the first 28 days of life (Clinical presence of danger signs as per the IMNCI guidelines.)
[Time Frame: 28 days post recruitment]
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Secondary Outcome(s)
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Utilization of KMC Compliance, Frequency and duration
[Time Frame: 28 days post recruitment]
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Reduction in the Incidence of omphalitis (Redness and Swelling of umbilical stump/cord (Inflammation))
[Time Frame: 28 days post recruitment]
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Failure to thrive (Weight, length and OFC appropriate for age as per WHO guidelines)
[Time Frame: 28 days post recruitment]
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Secondary ID(s)
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3106-Ped-ERC-14
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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