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Evaluation of a continuous neonatal temperature monitor for low-resource settings: a device feasibility pilot study.

ABSTRACT: Objective:Evaluate a novel continuous temperature monitor in a low-resource neonatal ward. Design:We developed a low-cost continuous neonatal temperature monitor (NTM) for use in low-resource settings. Accuracy of NTM was initially assessed in the laboratory. Clinical evaluation then was performed in a neonatal ward in a central hospital in Malawi; eligible neonates (<1?week of age) were recruited for continuous temperature monitoring with NTM and a Philips Intellivue MP30 Patient Monitor. Interventions and outcome measures:The temperature probes of NTM and the reference patient monitor were attached to the infant's abdomen, and core temperature was continuously recorded for up to 3?hours. Axillary temperatures were taken every hour. We compared temperatures measured using NTM, the patient monitor and the axillary thermometer. Results:Laboratory temperature measurements obtained with NTM were within 0.059°C (range: -0.035°C to 0.195°C) of a reference thermometer. A total of 39 patients were recruited to participate in the clinical evaluation of NTM; data from four patients were excluded due to faulty hardware connections. The mean difference in measured temperatures between the NTM and the Intellivue MP30 was -0.04°C (95%?CI -0.52°C to 0.44°C). Conclusion:NTM meets ISO 80601-2-56 standards for accuracy and is an appropriate, low-cost continuous temperature monitor for neonatal wards in low-resource settings. Trial registration numbers:NCT03965312 and NCT03866122.

SUBMITTER: Sosa Saenz SE

PROVIDER: S-EPMC7228652 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Evaluation of a continuous neonatal temperature monitor for low-resource settings: a device feasibility pilot study.

Sosa Saenz Sonia E SE Hardy Mary Kate MK Heenan Megan M Oden Z Maria ZM Richards-Kortum Rebecca R Dube Queen Q Kawaza Kondwani K

BMJ paediatrics open 20200507 1

<h4>Objective</h4>Evaluate a novel continuous temperature monitor in a low-resource neonatal ward.<h4>Design</h4>We developed a low-cost continuous neonatal temperature monitor (NTM) for use in low-resource settings. Accuracy of NTM was initially assessed in the laboratory. Clinical evaluation then was performed in a neonatal ward in a central hospital in Malawi; eligible neonates (<1 week of age) were recruited for continuous temperature monitoring with NTM and a Philips Intellivue MP30 Patient ...[more]

PMID: 32426530

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Project description:BackgroundThe CRADLE-3 trial is a stepped-wedge randomised controlled trial aiming to reduce maternal mortality and morbidity by implementing a novel vital sign device (CRADLE Vital Sign Alert) and training package into routine maternity care in 10 low-income sites. The MRC Guidance on complex interventions proposes that interventions and implementation strategies be shaped by early phase piloting and development work. We present the findings of a three-month mixed-methodology feasibility study for this trial, describe how this was informed by the MRC guidance and the study design was refined.MethodsThe fidelity, dose, feasibility and acceptability of implementation and training materials were assessed in three representative non-trial sites (Zimbabwe, Ethiopia, India) using multiple-choice questionnaires, evaluation of clinical management (action log), healthcare provider (HCP) semi-structured interviews and focus groups 4-10 weeks after implementation. Simultaneously, the 10 sites included in the main trial (eight countries) collected primary outcome data to inform the power calculation and randomisation allocation and assess the feasibility of data collection.ResultsThe package was implemented with high fidelity (85% of HCP trained, n?=?204). The questionnaires indicated a good understanding of device use with 75% of participants scoring >?75% (n?=?97; 90% of those distributed). Action logs were inconsistently completed but indicated that the majority of HCP responded appropriately to abnormal results. From 18 HCP interviews and two focus groups it was widely reported that the intervention improved capacity to make clinical decisions, escalate care and make appropriate referrals. Nine of the ten main trial sites achieved ethical approval for pilot data collection. Intensive care was an inconsistent marker of morbidity and stroke an infrequent outcome and therefore they were removed from the main trial composite outcome. Tools and methods of data collection were optimized and event rates used to inform randomisation.ConclusionsThis feasibility study demonstrates that the components of the intervention were acceptable, methods of implementing were successful and the main trial design would be feasible. Qualitative work identified key moderators that informed the main trial process evaluation. Changes to the training package, implementation strategy, study design and processes were identified to refine the implementation in the main trial.Trial registrationISRCTN41244132 ; Registered 24/11/2015.

Project description:ObjectiveThere is no consensus on the essential parameters to monitor during childbirth, when to start, and the rate of monitoring them. User disagreement contributes to inconsistent use of the twelve-item modified World Health Organization partograph that is started when the cervix is at least 4 cm dilated. The inconsistent use is associated with poor outcomes at birth. Our objective was to identify the perspectives of childbirth experts on what and when to routinely monitor during childbirth in low resource settings as we develop a more acceptable childbirth clinical decision support tool.MethodWe carried out a Delphi study with two survey rounds in early 2018. The online questionnaire covered the partograph items like foetal heart, cervical dilation, and blood pressure, and their monitoring rates. We invited panellists with experience of childbirth care in sub-Saharan Africa. Consensus was pre-set at 70% panellists rating a parameter and we gathered some qualitative reasons for choices.ResultsWe analysed responses of 76 experts from 13 countries. There was consensus on six important parameters including foetal heart rate, amniotic fluid clearness, cervical dilation, strength of uterine contractions, maternal pulse, and blood pressure. Two in three experts expressed support for changing the monitoring intervals for some parameters in the partograph. 63% experts would raise the partograph starting point while 58% would remove some items from it. Consensus was reached on monitoring the cervical dilation at 4-hourly intervals and there was agreement on monitoring the foetal heart rate one-hourly. However, other parameters only showed majority intervals and without reaching agreement scores. The suggested intervals were two-hourly for strength of uterine contractions, and four-hourly for amniotic fluid thickness, maternal pulse and blood pressure. The commonest reason for their opinions was the more demanding working conditions.ConclusionThere was agreement on six partograph items being essential for routine monitoring at birth, but the frequency of monitoring could be changed. To increase acceptability, revisions to birth monitoring guidelines have to be made in consideration of opinions and working conditions of several childbirth experts in low resource settings.

Dataset Information

Evaluation of a continuous neonatal temperature monitor for low-resource settings: a device feasibility pilot study.

Publications

Evaluation of a continuous neonatal temperature monitor for low-resource settings: a device feasibility pilot study.

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