Evaluating the NeoTree in Malawi and Zimbabwe

NCT05127070 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 19000

Last updated 2022-05-18

No results posted yet for this study

Summary

Neonatal mortality remains unacceptably high. Globally, the majority of mothers now deliver in health facilities in low resource settings where quality of newborn care is poor. Health systems strengthening through digitial quality improvement systems, such as the Neotree, are a potential solution. The overarching aim of this study is to complete the co-development of NeoTree-gamma with key functionalities configured, operationalised, tested and ready for large scale roll out across low resource settings.

Specific study objectives are as follows:

1. To further develop and test the NeoTree at tertiary facilities in Malawi and Zimbabwe
2. To investigate HCPs and parent/carer view of the NeoTree, including how acceptable and usable HCWs find the app, and potential barriers and enablers to implementing/using it in practice.
3. To collect outcome data for newborns from representative sites where NeoTree is not implemented.
4. To test the clinical validity of key NeoTree diagnostic algorithms, e.g. neonatal sepsis and hypoxic ischaemic encephalopathy (HIE) against gold standard or best available standard diagnoses.
5. To add dashboards and data linkage to the functionality of the NeoTree
6. To develop and test proof of concept for communicating daily electronic medical records (EMR) using NeoTree
7. To initiate a multi-country network of newborn health care workers, policy makers and academics.
8. To estimate cost of implementing NeoTree at all sites and potential costs at scale

Conditions

  • Prematurity
  • Neonatal Encephalopathy
  • Neonatal Sepsis
  • Neonatal Death
  • Neonatal Seizure
  • Neonatal Jaundice
  • Neonatal Hypoglycemia
  • Neonatal Hypothermia
  • Neonatal Disorder
  • Neonatal Respiratory Failure

Interventions

DEVICE

Neotree

The Neotree is a digital app, data collection and quality improvement system. collecting and collating routine health data at the bedside for babies on admission and discharge and for laboratory results. it provides point of care education and clinical decision support to optimise the clinical care of sick and vulnerable newborns according to approved and best available clinical guidelines.

Sponsors & Collaborators

  • Biomedical Research and Training Institute, Zimbabwe

    collaborator OTHER
  • PACHI Malawi - Parent and Child Health Initiative Trust

    collaborator OTHER
  • Ministry of Health and Child Welfare, Zimbabwe

    collaborator OTHER
  • University College, London

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2022-09-01
Completion
2022-09-01

Countries

  • Malawi
  • Zimbabwe

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05127070 on ClinicalTrials.gov