Original research••

Improvement of temperature surveillance of neonates in low-resource settings by a simple low-cost device: a descriptive study

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Abstract

Introduction Neonatal hypothermia in low-resource settings is prevalent and closely associated with high morbidity and mortality. We examined if an easy-to-read temperature detector device improves health outcomes.

Methods In a descriptive study, 1009 admissions to a neonatal ward in a tertiary care hospital in Lilongwe, Malawi, were analysed and divided into a baseline and a trial group. The data of 531 newborns with standard care (SC) before the trial were compared with 478 newborns during the implementation of the device (device care=DC). Staff and caregivers were trained on using the device and how to react in case of hypothermia. Data were collected from patient files, device documentation sheets, interviews and focus group discussions. Hypothermia was defined as a body temperature <36.5°C.

Results During the trial, body temperatures throughout the hospital stay were significantly more often obtained (p<0.0001). The median temperature measurements per newborn per day were 1.3 times with SC and 1.6 times with DC, and mild hypothermia was more frequently detected. Moderate hypothermia was avoided in the lightest weight group possibly contributing to significantly shorter hospital stays of surviving newborns (p=0.007). Many caregivers had difficulties using and interpreting the device correctly, and 47% of the reported colours did not match the registered temperatures. Contrary to the above, a questionnaire and focus group discussions with caregivers and health workers showed a high acceptance and the overall opinion that the device was beneficial.

Conclusion With more frequent temperature checks, infants with lower birth weight possibly benefited from implementing an easy-to-read continuous temperature indicator, but hypothermia rates remained high. Our data and experiences reveal structural, communicational and consistency/interpretation deficits. Although specifically designed for low-resource settings, the implementation of the device needs a well-working and structured environment, especially regarding staff and caregiver communication.

What is already known on this topic

Neonatal hypothermia is still a significant health problem in underserved or low-resource settings, and low-cost easy-to-read devices are needed to improve neonatal thermal care.

What this study adds

Effective and acceptable monitoring may be feasible and produce accurate results, and low birthweight infants might benefit in particular. Successful temperature management, however, requires specific operational strategies and individual support of caregivers in a well-prepared setting.

How this study might affect research, practice or policy

Although the value of a diagnostic device seems apparent, understanding local structural deficiencies, the motivation of caretakers and the perception of the device by the end user is crucial to create a benefit. Our findings have implications for health prevention research, and for the implementation of interventions with known efficacy.

Introduction

Worldwide, most childhood deaths occur in newborns, the highest percentage in sub-Saharan Africa.1 Since hypothermia plays a major role,2–10 the WHO defined thermal control as an essential component of newborn care.2 11 The impact of insufficient thermal protection and the frequency of hypothermia and its influence on mortality is underestimated in low-income and middle-income countries.3 12–15 In addition to cold delivery rooms,14 16 delayed drying and wrapping,17 18 no skin-to-skin care, late breastfeeding,13 14 17 only sporadic body temperature measurements,9 16 and, particularly in Malawi, high prematurity and low birth weight rates cause high prevalence of neonatal hypothermia.19–22 Limited perception of hypothermia, its risks and its management in caregivers and health workers are significant causes.16 23 24 Therefore, emphasis must lay on education, including training of health workers’ awareness and caregivers’ involvement.9 12 24–26

Despite a decrease in child mortality rates in Malawi since 1990, 1/37 live-born newborns died between 2010 and 2016,27 28 one significant contributing factor is most likely due to understaffing.29 30

Kamuzu Central Hospital (KCH), Lilongwe, Malawi, is a tertiary care referral hospital with approximately 2550 annual admissions to neonatal services. In 2017, 2.5% of all live-born neonates and 14% of all neonatal admissions died. The staffing of the neonatal unit usually consisted of 8 full-time nurses and 1–2 physicians. Mothers could visit their children for feeding every 2 hours. Lack of air conditioning and opening of windows most of the times equalised outside and inside air temperature. The first investigation in 1988 found a high incidence of neonatal hypothermia, and the problem persists.31

This study described the current thermosurveillance of neonates at KCH and examined the impact of a low-cost temperature-monitoring device on health outcomes and awareness about neonatal hypothermia, focusing on the newborn’s caretakers, with an expectation to reduce neonatal hypothermia rates and improve health outcomes. It also assessed the acceptance of nurses and caregivers.

Methods

Patient and public involvement

The caregivers of patients were not involved in this trial’s conceptualisation, design or conduct. The results of this study will not be disseminated directly to participants.

Study design and conduct

From December 2017 to May 2018, we included 1009 newborns in a descriptive study on implementing a low-cost temperature-monitoring device, a non-invasive temperature indicator placed on the newborn’s skin.32 It changes colour according to the body temperature. At normothermia of 36.5°C–37.5°C, its colour is bright green with a smiling face. With decreasing body temperature, it turns yellow/pale green and subsequently red/brown.32 At 35.5°C and below, the colour changes to black, and the smiling face disappears.32 With elevated body temperatures, the device turns blue.33 Several studies confirmed the device’s accuracy, sensitivity and specificity.32 34–36 The acceptability of the device among mothers in Malawi is high.37

In the first 3 months of the study, baseline data at standard temperature surveillance were collected (standard care=SC). The device was integrated into the daily temperature surveillance (device care=DC) in the subsequent 3 months. All newborns admitted to the neonatal unit were eligible to participate, and study personnel trained the staff on using the device and handling hypothermia. A study assistant instructed caregivers to place the device at admission, to leave it in place until the last day, and to report its colour on a sheet (device sheet) by ticking the appropriate coloured box each time they checked the device. Since female relatives also take care of the infants, we use the term caretaker.

Options on how to warm a hypothermic newborn (skin-to-skin care, wrapping, using hats, changing wet diapers, using a heating lamp, closing windows, asking another caregiver or a nurse/clinician for help) were explained, and fact sheets about the options given. A study assistant measured the axillary body temperature with a thermometer four times daily in both periods during weekdays. On weekends, the nurse on duty was paid a small amount for the extra work. Study supervisors were available to answer questions and monitor the procedures. The adherence to the device was assessed with the device sheet, and satisfaction with it by a questionnaire with a Likert scale, individual interviews with nurses, a focus group discussion (FGD) with 12 caregivers and an FGD with the study team. Every 2 weeks, the study team met to evaluate the progress.

Data collection and processing

We extracted quantitative data from the patient files and the device sheets for the first 12 days of hospitalisation and additionally evaluated the questionnaires.

The inclusion criteria were age at admission <29 days old, birth weight >1000 g and gestational age >28 weeks. Exclusion criteria were severe malformation, unlikeliness to survive and not using the device during the DC period.

Due to many implausible or missing values, all recordings were edited manually, and entries that did not match a predefined range in quantity or quality were considered invalid or corrected retrospectively according to internal criteria. Therefore, the sample size for a calculation may differ from the total sample size.

Hypothermia was defined as per WHO: body temperature of >36.4°C=normothermia, 36.0°C–36.4°C=mild hypothermia, 32.0°C–35.9°C=moderate hypothermia, <32.0°C=severe hypothermia.

Statistical analysis

The data were evaluated using GraphPad Prism V.8.4.3 (471), GraphPad Software, San Diego, California, USA, and Microsoft Excel V.16.16.27 (202012) Microsoft, Redmond, Washington, USA, under the advice of the Institut für Medizinische Informationsverarbeitung Biometrie und Epidemiologie, LMU.

For descriptive analyses, absolute and relative frequencies, means, medians, and 25% and 75% quartiles were calculated, and cross-tables were used to determine possible factors influencing the different variables with stratifications by admission weight. For unpaired, non-normal distributed groups, the Mann-Whitney U test, for multiple testing, the Bonferroni correction was used. The level of significance was determined as 0.05. All p values are two-sided. Qualitative data were analysed descriptively.

Results

In the 6-month study period, we recorded 1155 admissions (50% in SC and DC) and an 87% (1009) inclusion rate (531 SC/478 DC). 42 infants in the SC group and 58 infants in the DC group did not meet the inclusion criteria, and 46 were excluded in the DC group for not using the device.

Body temperature at admission was obtained in most infants receiving SC and DC (SC 93%/DC 95%), and around 60% were hypothermic. The trend for admission hypothermia in children with DC reached significance only for newborns with 1501–2500 g admission weight, probably due to significantly colder room temperatures during the DC period (min 26.8°C (median 36.0, 25% percentile 33.0, 75% percentile 38.0, max 41.1) vs min 24.4°C (median 34.9, 25% percentile 33.0, 75% percentile 37.0, max 41.8), p<0.0001).

More admission and significantly more in-ward body temperatures were taken in infants with DC (missing admission temperatures: 7.5% (40) at SC vs 5.4% (26) at DC; missing in-ward temperatures: 62% (7797 of 12 568) at SC vs 59% (6654 of 11 340) at DC (p<0.0001)). The median temperature measurements per newborn per day were 1.3 times in infants receiving SC (min 0.0, 25% percentile 0.8, 75% percentile 2.0, max 4.0) and 1.6 times in infants receiving DC (min 0.0, 25% percentile 1.0, 75% percentile 2.3, max 4.0).

Figure 1 shows the proportions of the temperature ranges of all documented temperatures after admission, stratified by admission weight. The frequency of measurements for the individual newborns varied widely; some newborns contributed more data than others. Due to small sample sizes, data of newborns with severe hypothermia were excluded for statistical tests and from the graph (one measurement at SC). The distribution of recorded temperatures between the study periods did not differ significantly for normothermia, mild and moderate hypothermia, and hyperthermia within the weight groups (≤1500 g: p=0.162, 1501–2500 g: p=0.106, >2500g: p=0.092). A trend to more normothermic temperatures was measured in all weight groups in children receiving DC. We observed fewer episodes of moderate hypothermia in the lowest birth weight newborns, and the middleweight group showed more mild hypothermia in infants receiving DC, but these did not reach statistical significance.

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Figure 1

Temperatures during hospital stay. DC, device care; SC, standard care.

However, significantly more newborns with admission weights of >2500 g receiving DC had at least one measured temperature in the hypothermic range (p=0.004).

The median length of hospital stay was shorter in all weight groups receiving DC. The median stay for infants with admission weight ≤1500 g decreased significantly from 23 to 15 days (p=0.007), but not significantly for those >1500 g, with already short median stays of 5 and 4 days. the DC group received significantly less often antibiotics (77% vs 85%; p=0.001).

Frequently during device use, the data on the documentation sheets by caregivers were either missing or implausible. However, even when excluding the obviously wrong sheets, care improved in children with DC since temperature monitoring was performed significantly more often at least the four planned times a day (p<0.0001) when combining the monitoring of nurses by thermometer and caregivers. The median of daily temperature checks by nurses was 2.3 times (min 0.1, 25% percentile 1.5, 75% percentile 3.5, max 9.0) while the median of the combined checks by nurses and caregivers was 8.4 times a day (min 0.1, 25% percentile 4.5, 75% percentile 11.7, max 31.0). Figure 2 shows the percentages of correctly and incorrectly documented ticks through caregivers compared with the measured temperatures.

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Figure 2

Correctness of temperature documentation (ticked colours) by caregivers near here.

In 14% (256) of the 1860 patient days on correctly completed device sheets, at least one tick was in the hypothermic range. In 64% of those hypothermic ticks, an appropriate reaction of the caregiver to increase the newborn’s body temperature was reported. A contraproductive action was documented in 0.6% of the days with a hypothermic tick.

372 caregivers completed the questionnaire to assess their opinions. The majority agreed or strongly agreed to questions about ease of understanding (99%) and recognition of colour (98%), and they felt safe about the baby’s temperature (98%) and knew what to do when the device colour changed (97%).

While nurses in the interviews and FGD agreed that the device would reduce their workload, in our observations, only a minority would use it correctly and accept it as a help rather than a burden. Nearly all caregivers interviewed stated that they would like to acquire the device for home use despite many objective difficulties in understanding and correctly using the device.

Discussion

In children receiving DC, the percentage of hyperthermia, normothermia, and mild and moderate hypothermia did not differ significantly compared with those receiving SC; however, we saw a trend towards normothermia in all weight groups and more successful identification of hypothermia in infants with >2500 g, who in the past escaped attention. There was a shift to less moderate hypothermia in infants ≤1500 g and more mild hypothermia in infants 1501–2500 g, evidence of early detection and successful treatment of hypothermia with a reduction of hospitalisation time in the lightest weight group and use of antibiotics.

The gain for nursing staff by shifting temperature control to the caregivers was nullified by the time required to introduce the device in a setting with significant staff shortage and insufficient time to supervise the correct use and reporting. Supervision was too short and disrupted to enable the caregivers to be independent users or collect the correct data to obtain more reproducible results. This issue also hindered a timely response to hypothermia when noted by caregivers. Reeducation, however, significantly improved performance.

In addition to a lack of support and encouragement to use the device by nursing staff, restricted and limited visiting times reduced temperature control and warming by caregivers. Although its positive effects are known,38 skin-to-skin care is rarely used.

The success of more frequent monitoring by caregivers is an important first step in addressing the problem of neonatal hypothermia. The fact, that caregivers documented action in more than half of the hypothermic ticks, indicates that the study enabled steps in the desired direction. However, significant difficulties existed since utensils such as protocols and pencils disappeared to a substantial degree. Also, equipment to warm the newborns was often unavailable, due to broken or too few heating devices and the unavailability of hats, blankets or diapers. Consequently, caregivers were often willing but unable to act on their observation and intervene.

The interpretation of colours and even their definition was surprisingly problematic. The accuracy of the device has been proven in various studies. However, most of those studies only distinguished between a black (severe hypothermia) and a non-black colour,34–36 but not between moderate and mild hypothermia and normothermia, as in this study. Those different shades of colours (red/brown, pale green/yellow, green) were difficult to differentiate even for study personnel experienced in using the device, specifically between normothermia and mild hypothermia. In the primary local language, caregivers and nursing staff could not agree on a distinction between green and blue, as, according to Berlin and Kay, less expressions for different colours exist in tribal languages.39 There seems to be a need for culturally specific training with regard to interpreting the colours of the device, despite its inherent intuitive aspect of the colour scheme. Possibly only two possible interpretations (hypothermia/no hypothermia) would have been more effective for the study objective of a targeted reaction in case of hypothermia.

Including the same device in a package of clothes and instructions on caring for a newborn did not significantly add to survival compared with instruction and clothing alone. Mortality was already reduced by nearly 50% by instruction and clothing alone.40

Through training, interaction and peer exchange, the caregivers were more aware of hypothermia and asked for the device on arrival. Due to the short turnover times of the newborns, however, many caregivers could not value the product’s efficacy, which reduced adherence. Nevertheless, in FGDs, most participants said they would buy the device for their next child.

The FGDs and individual interviews with nurses revealed significant reasons for discouragement in this setting: low financial incentives to participate, general understaffing and overwhelming workload. While head nurses were usually supportive, to their disappointment, it was challenging to motivate lower-level staff.

In general, we could not significantly enhance motivation to use the device, although all care providers reported its advantages and simplicity in use.

Conclusion

Implementation of the device led to increased body temperature measurements but did not significantly decrease hypothermia. It reduced the hospital stay time for lower birth weight infants and antibiotic use. Clearly, the structural deficiency, communication problems, staff shortage and difficulties interpreting the device impacted the results. There is rather a large discrepancy between the expectation of a positive effect of a simple device and the reality of clinical use.

Contributors: AP is a Malawian paediatrician and senior lecturer at the University of Malawi College of Medicine and was involved in the project from the beginning. He has experience conducting research in the study setting and contributed crucial ideas, concerns and advice regarding the content and cultural context. He was also an essential mediator between hospital staff and foreign researchers in optimising processes. Additionally, AP has an excellent knowledge of the ethical approval processes and requirements in the setting and played a vital role in this regard. Before and during the research, AS, a Malawian resident, was employed by the College of Medicine, University of Malawi as a senior lecturer and regular staff member. As a paediatrician and public health expert, he knows health challenges in the Malawian system and came up with the idea for the research. He brought a high level of expertise in organising international research, including low-income and middle-income countries, collaboration with local professionals, and communication between local and foreign researchers. JG and OG-B are both from a HIC and were, during the research, affiliated with a university in that country. JG was responsible for coordinating the data collection process and was present at the study site. JG collaborated with many local nurses and clinicians to understand and improve the roots of issues during the collection process. As a neonatologist, OG-B has high expertise in research in this field. As a senior researcher, she was an advisor during all phases of the study and is responsible for the overall content as the guarantor.
Funding: The Else-Kröner-Fresenius Stiftung, Germany/BMZ and LMU funded part of the costs. No additional funding was available. The temperature devices were purchased from Health Books International, formerly TALC, UK, who played no additional role or had access to the data presented.
Disclaimer: The funders had no influence on the study design, data collection, analysis, and data interpretation, in the report's writing or the decision to submit for publication.
Competing interests: All authors have completed the ICMJE uniform disclosure form and declare that the study received financial support from Else-Kröner-Fresenius Stiftung and that JG received financial support from LMU, as explained under 'Funding'.
Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review: Not commissioned; internally peer reviewed.

Data availability statement

Data are available on reasonable request. Data can be requested by email to the corresponding author.

Ethics statements

Patient consent for publication:

Ethics approval:

The study conformed to the Declaration of Helsinki (2013). Written informed consent was obtained from legal caregivers. The study was designed and conducted by members of the protocol team, who collected data, monitored and performed statistical analyses. The research ethical committees of the College of Medicine of the Kamuzu University of Health Sciences (COMRECP.05/18/2405) and the LMU Munich Medical Faculty (Pr Nr 18-83) approved the study.

Acknowledgements

We owe our greatest respect to all the hardworking and dedicated staff and caregivers of Kamuzu Central Hospital who engaged in the study despite an overwhelming daily workload and the most challenging living conditions. Special thanks go to Precious Dinga, Rhoda Banda, Prince Wanangwa and Tamandina Whayo, who supported this study with an incredible amount of work. We thank the Institut für Medizinische Informationsverarbeitung Biometrie und Epidemiologie, LMU for the support in the statistical analyses. Clinical data were collected together with the Baylor College of Medicine, Texas, USA, who concurrently created a general database for neonates at KCH.

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