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Monitoring during newborn kangaroo care

KangaCare - wireless monitoring during Kangaroo Care

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14913510
Enrollment
95
Registered
2024-12-10
Start date
2024-09-03
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal health Neonatal Diseases

Interventions

There are three recruitment arms for the study to address the primary and secondary outcomes outlined. All three parts will require participants to give informed consent, and researchers will follow t

Sponsors

University of Nottingham
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Infants who are deemed clinically stable enough to receive kangaroo care by the usual clinical care team 2. Infants requiring vital sign monitoring 3. All infants must have written informed consent from the parent Feedback and visual attention study: Parents/carers over 16 years old and healthcare providers who can provide informed written consent are eligible for the study.

Exclusion criteria

Exclusion criteria: 1. Infants who are undergoing end-of-life comfort care 2. Infants undergoing body cooling as part of their treatment 3. Infants who are deemed by clinical staff to be too unstable for kangaroo care

Design outcomes

Primary

MeasureTime frame
The accuracy and reliability of the KangaCare Monitoring System at measuring heart rate (bpm), oxygen saturation (%) and temperature (oC) compared with predicate pulse oximetry, ECG and temperature measurement devices currently used in practice. This will be measured by obtaining measurements of heart rate, oxygen saturation and temperature using the KangaCare monitoring system device alongside measurements of heart rate using ECG, oxygen saturation and temperature from monitoring devices currently used in neonatal clinical practice, recorded during each episode of routine Kangaroo care.

Secondary

MeasureTime frame
1. Parent and staff feedback on the wireless device, collected using a paper-based questionnaire after using the KangaCare Monitoring system over the study recruitment period. 2. Visual attention of parent/carer during kangaroo care based on percentage time looking at their infant, clinical space and other people in their clinical area. This will be collected using visual attention glasses during an episode of routine Kangaroo care.

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026