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Neonatal Package for Infection Reduction in Pakistan
NCT02279381Phase 4
Key facts
- Status
- Completed
- Start
- Nov 2014
- Primary completion
- Nov 2015
- Countries
- 1
- Sponsor
- Aga Khan University
- Modality
- Small Molecules
- Drugs
- chlorhexidine
- Conditions
- neonatal infection
01
Overview
Phase 4, randomised, open-label trial of chlorhexidine in neonatal infection (3 arms), sponsored by Aga Khan University. Primary endpoint: Reduction in the Incidence of Neonatal infections at 28 days. Started Nov 2014; status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
Intervention group A
Essential Neonatal Care + KMC + 4% Chlorhexidine
Intervention group B
Essential Neonatal Care + 4% Chlorhexidine
Control group
Essential Neonatal Care
03
Who it enrols
Healthy newborns born in the study settings without congenital defects or localized infection at birth.
04
Endpoints
Primary
Reduction in the Incidence of Neonatal infections
Secondary
Reduction in the Incidence of omphalitis
Failure to thrive
Utilization of KMC Compliance
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