The feasibility and acceptability of an early warning score system for preterm and low-birth weight infants in Kenya
Lead Research Organisation:
University of Nottingham
Department Name: School of Medicine
Abstract
Background: Globally 15 million babies are born preterm or "born too soon" each year. Nearly two-thirds of such births happen in sub-Saharan Africa and Asia. Premature birth is the cause for a third of all deaths in the first month of life. In Kenya, over 200,000 babies are "born too soon" and despite recent reductions, deaths in the first month of life remain high at 20 per 1000; 7 times higher than in the UK. Kenya suffer from a shortage of resources including lack of trained neonatal doctors and nurses. Poor record keeping in hospital causes delays in recognising poorly babies, in providing treatment and leads to poor outcomes. Early warning scores (EWS) are a streamlined way to monitor patients and prompt treatment to prevent deterioration that could lead to death. The "Newborn Early Warning Track and Trigger" (NEWTT) used in the UK uses a simple paper-based form, which has a "traffic-light system" to easily plot infants' vital signs (temperature, heart rate and respiratory rate). This promptly alerts healthcare professionals to take actions if signs are in the red or amber zones. Closer monitoring of preterm infants with a system that more easily identifies sicker infants could help resource-limited staff to reduce deaths and illness in this very vulnerable group.
Previous work: To understand how doctors and nurses care for preterm and low birth weight (LBW) infants in Kenya, we recently completed a study at a large hospital in Nairobi, Kenya. We collected data on 294 babies over 8 weeks and recorded vital signs on the NEWTT. We also spoke to 19 mothers and 20 stakeholders to explore their views of newborn care. The data were presented at a large meeting in Nairobi in July 2019 attended by around 80 people involved in care of preterm infants. The idea of implementing a EWS for preterm infants in Kenya was discussed and feedback was positive. They liked the simplicity of documentation using a traffic-light system for quick identification of high risk infants. Some barriers were discussed such as a recognition of need for training and resources such as nursing time and colour printed charts.
Current study: This study aims to test how feasible and acceptable it is to implement an EWS in neonatal units in Kenya. We will implement the paper-based EWS in three neonatal units and ask staff to complete this for all preterm or LBW infants over a 4-week period. When a vital sign is entered onto one red or two amber trigger zones, they will alert a more senior member of staff to assess the infant and advise further action. The EWS will temporarily replace the current documents to avoid duplication of work. We will also conduct interviews a range of healthcare professionals involved in caring for preterm infants. In order to include a range of opinions, we will aim to include 2-3 interviews with each type of staff, resulting in around 24-30 interviews.
Skills development: We will develop capacity to conduct research and increase the skills of our Kenyan partners. Three researchers, one from each hospital in Kenya, will visit the UK They will attend the well established Nottingham Fundamentals of Clinical Trials course (https://www.nottingham.ac.uk/nctu/short-courses/fundamentals-of-clinical-trials.aspx). Here they will learn basic skills in the design and conduct of clinical trials via a mixture of classroom style teaching and workshops and network with other course attendees. They will also spend time at Nottingham Clinical Trials Unit and the Liverpool School of Tropical Medicine to gain hands-on experience of clinical trials and discuss future opportunities.
Future work: The current study is a step in a longer-term programme of work to establish a practical and useful EWS for reducing death among preterm infants in resource-limited hospitals. If shown to be feasible and acceptable, we will undertake an appropriately designed clinical trial to test if using such an EWS will help save lives of those "born too soon".
Previous work: To understand how doctors and nurses care for preterm and low birth weight (LBW) infants in Kenya, we recently completed a study at a large hospital in Nairobi, Kenya. We collected data on 294 babies over 8 weeks and recorded vital signs on the NEWTT. We also spoke to 19 mothers and 20 stakeholders to explore their views of newborn care. The data were presented at a large meeting in Nairobi in July 2019 attended by around 80 people involved in care of preterm infants. The idea of implementing a EWS for preterm infants in Kenya was discussed and feedback was positive. They liked the simplicity of documentation using a traffic-light system for quick identification of high risk infants. Some barriers were discussed such as a recognition of need for training and resources such as nursing time and colour printed charts.
Current study: This study aims to test how feasible and acceptable it is to implement an EWS in neonatal units in Kenya. We will implement the paper-based EWS in three neonatal units and ask staff to complete this for all preterm or LBW infants over a 4-week period. When a vital sign is entered onto one red or two amber trigger zones, they will alert a more senior member of staff to assess the infant and advise further action. The EWS will temporarily replace the current documents to avoid duplication of work. We will also conduct interviews a range of healthcare professionals involved in caring for preterm infants. In order to include a range of opinions, we will aim to include 2-3 interviews with each type of staff, resulting in around 24-30 interviews.
Skills development: We will develop capacity to conduct research and increase the skills of our Kenyan partners. Three researchers, one from each hospital in Kenya, will visit the UK They will attend the well established Nottingham Fundamentals of Clinical Trials course (https://www.nottingham.ac.uk/nctu/short-courses/fundamentals-of-clinical-trials.aspx). Here they will learn basic skills in the design and conduct of clinical trials via a mixture of classroom style teaching and workshops and network with other course attendees. They will also spend time at Nottingham Clinical Trials Unit and the Liverpool School of Tropical Medicine to gain hands-on experience of clinical trials and discuss future opportunities.
Future work: The current study is a step in a longer-term programme of work to establish a practical and useful EWS for reducing death among preterm infants in resource-limited hospitals. If shown to be feasible and acceptable, we will undertake an appropriately designed clinical trial to test if using such an EWS will help save lives of those "born too soon".
Technical Summary
Globally, 15 million babies are born preterm each year and prematurity is the leading cause of neonatal death. UNICEF's sustainable development goals have ambitious targets to reduce the neonatal mortality rate to less than 12 per 1000 births: in Kenya, the rate is 20.
Early warning signs (EWS) are a streamlined way of recording clinical data to enable prompt identification of adverse signs and prompt
appropriate escalation of care. In the UK, the Newborn Early Warning Track and Trigger System (NEWTT) is used for preterm babies. Like many other EWS, it is a simple, paper form which uses a traffic light colour-coded system to record infants' vital signs.
We plan to implement an adaption of the NEWTT in three hospital neonatal units in Kenya. We will conduct an observational study over a 4-week period and parallel qualitative study. The three hospitals representing different levels of care and resources in Kenya have agreed to collaborate. Healthcare professionals will be asked to use the EWS to document vital signs of all infants born at <37 weeks and/or <2.5kg and follow the specified action plan until the infant is discharged home or dies. In addition, they will be asked to state whether the EWS was followed, what action was taken and what the outcome of the infant was. Data will be entered onto a REDCap database. We will also collect minimal data on infants who did not have their vital signs recorded on the EWS.
The qualitative study will involve interviews with healthcare professionals and policy-makers. Transcribed interviews will be thematically analysed.
To increase the research capacity, knowledge and skills amongst our Kenyan collaborators, three researchers will visit the UK for a 2-week training period. They will attend the Nottingham Fundamentals of Clinical Trials Course and be exposed to day-to-day experience of running clinical trials within the Nottingham Clinical Trials Unit and Liverpool School of Tropical Medicine.
Early warning signs (EWS) are a streamlined way of recording clinical data to enable prompt identification of adverse signs and prompt
appropriate escalation of care. In the UK, the Newborn Early Warning Track and Trigger System (NEWTT) is used for preterm babies. Like many other EWS, it is a simple, paper form which uses a traffic light colour-coded system to record infants' vital signs.
We plan to implement an adaption of the NEWTT in three hospital neonatal units in Kenya. We will conduct an observational study over a 4-week period and parallel qualitative study. The three hospitals representing different levels of care and resources in Kenya have agreed to collaborate. Healthcare professionals will be asked to use the EWS to document vital signs of all infants born at <37 weeks and/or <2.5kg and follow the specified action plan until the infant is discharged home or dies. In addition, they will be asked to state whether the EWS was followed, what action was taken and what the outcome of the infant was. Data will be entered onto a REDCap database. We will also collect minimal data on infants who did not have their vital signs recorded on the EWS.
The qualitative study will involve interviews with healthcare professionals and policy-makers. Transcribed interviews will be thematically analysed.
To increase the research capacity, knowledge and skills amongst our Kenyan collaborators, three researchers will visit the UK for a 2-week training period. They will attend the Nottingham Fundamentals of Clinical Trials Course and be exposed to day-to-day experience of running clinical trials within the Nottingham Clinical Trials Unit and Liverpool School of Tropical Medicine.
Planned Impact
Who will benefit from this research?
- Academics: please refer to the academic beneficiaries section of this proposal
- Clinicians and allied health professionals, including neonatologists, obstetricians, midwives, nurses, trained neonatal nurses
- Policy-makers such as the Ministry of Health and hospital management staff
- Non-government organisations involved in newborn care in Kenya, such as UNICEF and the Kenya Paediatric Association
- Parents of preterm or low birth weight infants
- Preterm or low birth weight infants
How will they benefit from this research?
Capacity-building / future research: Please see the academic beneficiaries section of this application.
Informing clinical practice: Clinicians and allied health professionals will benefit first hand from receiving training in the importance of close vital sign monitoring and recording quality data in this group of infants. This knowledge and these skills will be important in the short-term and longer term for future developments in this area of research. Engagement with the "end-users" of the EWS, i.e. the staff who complete the documentation, will be crucial in the success of this and future research in this area. In future research, if EWS is implemented, clinicians and allied health professionals could benefit greatly by having a simple, standardised system for monitoring and recording infants' vital signs. This standardised system could improve the quality of care since significant experience in neonatal care is not required in order to use it.
Newborn health policy decision-making: Utilising data from this study, and our previous mixed-methods study, will help inform decision-making for policy-makers such as the Ministry of Health and hospital managers, responsible for the development and implementation of national and local guidelines. Again, involvement in these end-users throughout and beyond the duration of the study is key. Ministry of Health staff have been involved in our previous study, as demonstrated in our impact video (https://www.nottingham.ac.uk/nctu/other-research/global-health-research.aspx) and we will engage with them and hospital managers during the qualitative study interviews to ensure their opinions are included.
Results implementation: A wide range of non-government organisations (NGOs) are involved in the maternal and newborn health agenda in Kenya. Similar to benefits seen by policy-makers, NGOs can utilise the data and results from this and our previous study in order to help shape the newborn health agenda for preterm and low birth weight infants. Many NGOs provide direct support and work closely with other organisations in order to ensure a streamlined approach to newborn care in this setting.
Clinical benefits: During this feasibility study, mothers and families of preterm or low-birth weight infants will benefit from having their infants monitored more closely during the data collection period. If the EWS is followed and a vital sign is plotted to a red or amber zone, this will trigger escalation to a more senior member of staff, who should review the infant and take action accordingly. Mothers and families may appreciate this level of care and support for their infant. In the longer term, should the EWS be implemented, a reduction in mortality and serious morbidities may be seen, thus increasing the survival chances for preterm infants and reducing the burden of preterm birth on families.
- Academics: please refer to the academic beneficiaries section of this proposal
- Clinicians and allied health professionals, including neonatologists, obstetricians, midwives, nurses, trained neonatal nurses
- Policy-makers such as the Ministry of Health and hospital management staff
- Non-government organisations involved in newborn care in Kenya, such as UNICEF and the Kenya Paediatric Association
- Parents of preterm or low birth weight infants
- Preterm or low birth weight infants
How will they benefit from this research?
Capacity-building / future research: Please see the academic beneficiaries section of this application.
Informing clinical practice: Clinicians and allied health professionals will benefit first hand from receiving training in the importance of close vital sign monitoring and recording quality data in this group of infants. This knowledge and these skills will be important in the short-term and longer term for future developments in this area of research. Engagement with the "end-users" of the EWS, i.e. the staff who complete the documentation, will be crucial in the success of this and future research in this area. In future research, if EWS is implemented, clinicians and allied health professionals could benefit greatly by having a simple, standardised system for monitoring and recording infants' vital signs. This standardised system could improve the quality of care since significant experience in neonatal care is not required in order to use it.
Newborn health policy decision-making: Utilising data from this study, and our previous mixed-methods study, will help inform decision-making for policy-makers such as the Ministry of Health and hospital managers, responsible for the development and implementation of national and local guidelines. Again, involvement in these end-users throughout and beyond the duration of the study is key. Ministry of Health staff have been involved in our previous study, as demonstrated in our impact video (https://www.nottingham.ac.uk/nctu/other-research/global-health-research.aspx) and we will engage with them and hospital managers during the qualitative study interviews to ensure their opinions are included.
Results implementation: A wide range of non-government organisations (NGOs) are involved in the maternal and newborn health agenda in Kenya. Similar to benefits seen by policy-makers, NGOs can utilise the data and results from this and our previous study in order to help shape the newborn health agenda for preterm and low birth weight infants. Many NGOs provide direct support and work closely with other organisations in order to ensure a streamlined approach to newborn care in this setting.
Clinical benefits: During this feasibility study, mothers and families of preterm or low-birth weight infants will benefit from having their infants monitored more closely during the data collection period. If the EWS is followed and a vital sign is plotted to a red or amber zone, this will trigger escalation to a more senior member of staff, who should review the infant and take action accordingly. Mothers and families may appreciate this level of care and support for their infant. In the longer term, should the EWS be implemented, a reduction in mortality and serious morbidities may be seen, thus increasing the survival chances for preterm infants and reducing the burden of preterm birth on families.
| Description | We conducted a mixed-methods study to test feasibility and acceptability of an early warning score (EWS) on newborn units in Kenya. We adapted an existing monitoring chart, where clinical staff recorded babies' vital signs (e.g. temperature, heart rate, respiratory rate). We added an "early warning score" to the chart, using a traffic light system, enabling clinical staff to easily identify an abnormal vital sign, needing action. Over 9 weeks, 465 babies were included in an observational study, where clinical staff used the adapted chart to record vital signs. Around half of the babies included were discharged home, on average around 12 days after admission to the newborn unit. A quarter of babies died before discharge; most deaths occurred within the first 7 days of life. The adapted monitoring chart was completed at least once during a baby's hospital admission for 94% of babies. To test feasibility of chart completion, we defined "completed" as the chart being filled in for at least 50% of the days of the baby's hospital admission. On average, the adapted monitoring chart was completed, as per our definition, for 76% of the days during the baby's stay. This differed between the 3 hospitals. We looked at whether there were differences between use of the adapted monitoring chart, depending upon the shift patterns within the newborn units. Only very small differences were noted, but these were not considered significant. We talked to 28 health professionals and mothers about experiences of using the adapted chart and involvement in care. Health professionals liked the simplicity of the chart feeling it enabled better communication between health professionals, particularly at handover. Mothers also reported they wanted to be involved in the care of their baby and liked they could see the chart at the end of the cot; it helped communication between parents and health professionals. Health professionals reported significant challenges with staffing levels and workload, feeling that completion of the chart added to workload. They also reported that many activities required in caring for a newborn baby could be carried out by nursing staff and abnormal vital signs often did not require "escalation" to a more senior member of staff, since they could implement action directly. Overall, completion of the form was considered feasible and acceptable to health professionals and mothers. However, for babies with abnormal sets of vital signs, care was only escalated (in line with the EWS), 16% of the time. This could be due to significant staffing resource problems, but also due to the terminology/language used on the form. Rather than "escalation", "action taken" may have been more appropriate and relevant since ultimately, it is the action taken upon noting an abnormality that's important, if we are to improve outcomes for babies. The impact of using an EWS for babies on newborn outcomes requires evaluation in a randomised clinical trial. This study has demonstrated that some changes would be required before proceeding to designing a clinical trial. We also implemented a training programme for clinical/research staff. This involved 3 members of the Kenya research team attending a UK-based online clinical trials training course, which was well received. In addition, 7 webinars were held on research topics including clinical trial design, statistics, data management and trial conduct. Registrations for each seminar varied between 16-119 people, with attendance varying between 8-48 people. Seminar recordings were provided for all. |
| Exploitation Route | The study has demonstrated that completion of an early warning score is feasible. However, it is the triggering of action (when abnormal vital signs are noted) that could have most meaningful impact upon neonatal outcomes. In this study only 16% of abnormal vital signs were "escalated" to a more senior member of staff, in accordance with the chart recommendations. In designing a clinical trial designed to evaluate an early warning score and impact on clinical outcomes, it will be important to carefully consider the "triggering" element of the adapted chart, both in terms of language used on the chart, but staffing resource implications. The next steps will be to work closely as a team to co-develop a randomised clinical trial and apply for funding. |
| Sectors | Healthcare |
| Description | The study only completed in December 2021 and there are, therefore, few non-academic impacts. However, health professional staff in the newborn units liked the concept of having a colour-coded visual aid to easily identify babies with abnormal vital signs. Carry-cards were produced for the duration of the study and many health professionals have continue to refer to these beyond the end of the study. The qualitative study has demonstrated that mothers play a key role in the care of their newborns and want to work closely with health professionals on the newborn unit. The adapted chart could facilitate better communication between families and health professionals in the future, thus empowering women. |
| First Year Of Impact | 2021 |
| Sector | Healthcare |
| Impact Types | Cultural |
| Title | NEWS-K observational study dataset |
| Description | Data collected during the observational study within this award. Data on 465 preterm and/or low birth weight infants (<37 weeks and/or <2.5 kg) from three participating hospitals: Kenyatta National Referral Hospital, Thika Level 5 Hospital and Mama Lucy Kibaki Hospital in Kenya. |
| Type Of Material | Database/Collection of data |
| Year Produced | 2022 |
| Provided To Others? | No |
| Impact | It is currently too early to describe any notable impact as a result of this dataset - the results have only just been made available and will be discussed within the UK-Kenya research team. |
| Title | NEWS-K qualitative study dataset |
| Description | Anonymised transcripts from 1:1 interviews with health professionals and focus groups with mothers as part of the NEWS-K Study |
| Type Of Material | Database/Collection of data |
| Year Produced | 2022 |
| Provided To Others? | No |
| Impact | It is too soon to describe any notable impacts - the data has only just been analysed and will be discussed by the UK-Kenya team. |
| Description | Presentation to Dean of School of Medicine at University of Medicine |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | Local |
| Primary Audience | Other audiences |
| Results and Impact | Staff from Nottingham Clinical Trials and two key members of staff at the School of Medicine (the Dean, and Head of Operations) attended a lunchtime seminar to hear about the project. Questions and discussion afterwards. |
| Year(s) Of Engagement Activity | 2021 |
| Description | Presentation to Maternal Health and Wellbeing Group at University of Nottingham by co-applicant Dr Phoebe Pallotti |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | Local |
| Primary Audience | Other audiences |
| Results and Impact | Presentation about the study to Maternal and Newborn Health Research Group in School of Health Sciences at University of Nottingham, sparking questions and discussion about global health research |
| Year(s) Of Engagement Activity | 2021 |