Philippa Makobore – project lead with a clinical study nurse (Winnie Kibirige)
Project Lead(s): Philippa Ngaju Makobore
The process of administering intravenous fluids and medication during an infusion therapy in young children requires careful monitoring to prevent adverse outcomes such as fluid overload or under infusion due to difficulties in setting and maintaining an accurate flow rate. The current standard of care in most Sub Sahara African hospitals is manual regulation of intravenous fluids therefore the infusion process is highly prone to human error. This challenge is further compounded due to the clinician work burden characterized by high patient to staff ratios which make it difficult to monitor each child continuously. This project refined the Electronically Controlled Gravity Feed (ECGF) Infusion Set to improve its flow rate accuracy and subsequently assess the device’s safety and performance during an infusion therapy in Uganda. 5 prototypes of the ECGF were produced, pre-clinically tested, and used to conduct clinical trials. Clinicians were trained to install and operate the ECGF device and clinician time required to regulate and monitor fluids vs a fully automated process with the ECGF device was observed. The first in human pilot of 12 adults achieved flow rate accuracy of +/- 7% which is the percentage error margin between the prescribed and actual dosages. A clinical safety pilot in children aged 5-8 and subsequently a clinical trial in children aged 2 months to 5 years found that the most notable improvements were in children suffering from malaria, pneumonia, severe diarrhea and dehydration.
