Preterm Birth Clinical Trial
Official title:
The Use of Wireless Sensors in Neonatal Intensive Care (Wireless NICU)
NCT number | NCT04956354 |
Other study ID # | 2022-7704 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 15, 2022 |
Est. completion date | July 2024 |
The study will be conducted in a convenience sample of 75 infants admitted to the NICU at the Montreal Children's Hospital, divided into 3 phases: (a) Phase 1a - monitoring for 8h per day for 4 consecutive days, (b) Phase 1b - monitoring between 2h to 8h per day for 2 to 4 consecutive days, and (c) Phase 2- monitoring for 96h continuously. Study objectives include: 1. Demonstrate the feasibility of continuous wireless monitoring in term and preterm infants with variable degrees of maturation and acuity in the NICU. 2. Assess safety of using a special wireless sensor system in neonates. 3. Evaluate the accuracy of proposed wireless technology as compared to standard monitoring technology in the NICU.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | July 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Hours to 1 Month |
Eligibility | Inclusion Criteria: - Healthy term infants in room air at enrollment - Term infants with perinatal asphyxia undergoing therapeutic hypothermia at enrollment - Healthy preterm infants in room air at enrollment - Preterm infants on continuous positive airway pressure at enrollment - Preterm infants on conventional mechanical ventilation at enrollment - Preterm infants on high frequency ventilation at enrollment - Preterm infants on nasal intermittent positive end expiratory pressure at enrollment - Preterm infants on continuous positive airway pressure at enrollment Exclusion Criteria: - Congenital anomalies and surgical conditions (ex: gastroschisis, omphalocele, congenital diaphragmatic hernia) - Congenital heart disorders - Congenital skin infections or known conditions with fragile skin (such as epidermolysis bullosa) |
Country | Name | City | State |
---|---|---|---|
Canada | Montreal Children's Hospital | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Centre/Research Institute of the McGill University Health Centre | McGill University, Northwestern University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of wireless wearable heart rate data | Accuracy of wireless wearable heart rate data compared against the current standards of NICU bedside monitoring. | 4 consecutive days of wireless monitoring | |
Primary | Accuracy of wireless wearable respiratory rate data | Accuracy of wireless wearable respiratory rate data compared against the current standards of NICU bedside monitoring. | 4 consecutive days of wireless monitoring | |
Primary | Accuracy of wireless wearable skin temperature data | Accuracy of wireless wearable skin temperature data compared against the current standards of NICU bedside monitoring. | 4 consecutive days of wireless monitoring | |
Primary | Accuracy of wireless wearable oxygen saturation (SpO2) data | Accuracy of wireless wearable SpO2 data compared against the current standards of NICU bedside monitoring. | 4 consecutive days of wireless monitoring | |
Primary | Proportion of time exhibiting unreliable wireless device signals due to significant movement artifacts | Proportion of monitoring time exhibiting unreliable wireless device signals due to significant movement artifacts. The exact definition of unreliable for each of the signals will be outlined before study initiation. | 4 consecutive days of wireless monitoring | |
Primary | Proportion of time with loss of network connections or other technical problems | Proportion of time with loss of network connections or other technical problems from the wireless wearables vs. the NICU bedside monitoring. | 4 consecutive days of wireless monitoring | |
Primary | Skin integrity at the sites of sensor placement | Skin integrity at the site of wireless lead placements from de-identified digital photographs, evaluated by a board-certified dermatologist who will evaluate for signs of irritation, redness and/or erosions. | 4 consecutive days of wireless monitoring | |
Primary | Evaluation of potential subjective pain experienced by infant at time of sensor removal | Assessing infants for presence of acute pain associated with sensor removal by administering Neonatal Infant Pain Scale (NIPS) at time of device removal. | 4 consecutive days of wireless monitoring | |
Primary | Clinicians', nursing, and parental perceptions | Clinicians', nursing, and parental perceptions of the implementation of wireless wearable devices in the NICU. | 4 consecutive days of wireless monitoring | |
Secondary | Automated reports of physiological health - electrocardiogram | Automated reports for electrocardiogram acquired from the wireless monitoring device | 4 consecutive days of wireless monitoring | |
Secondary | Automated reports of physiological health - respiratory waveforms | Automated reports for respiratory waveforms acquired from the wireless monitoring device | 4 consecutive days of wireless monitoring | |
Secondary | Automated reports of physiological health - oxygen saturation | Automated reports for oxygen saturation acquired from the wireless monitoring device | 4 consecutive days of wireless monitoring | |
Secondary | Automated reports of physiological health - temperature | Automated reports for temperature acquired from the wireless monitoring device | 4 consecutive days of wireless monitoring | |
Secondary | Comparison between chest and respiratory inductance plethysmography (RIP) and the wireless monitoring device | For patients in Cohort 2, we will compare the chest and abdominal wall movement signals derived from accelerometry with RIP (the gold standard) with the simultaneously recorded wireless monitoring device data. | 2 to 3 consecutive hours each day during the 4-day continuous monitoring | |
Secondary | Enhanced respiratory monitoring using accelerometry | For patients in Cohort 2, we will compare the chest and abdominal wall movement signals derived from accelerometry with thoracic impedance (the current standard) with the simultaneously recorded wireless monitoring device data. | 2 to 3 consecutive hours each day during the 4-day continuous monitoring |
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