The main objective of the AWARD Project – Clinical Study is to evaluate the use of advanced wireless sensor technology to monitor neonates after birth in low-risk infants immediately after vaginal and c-section delivery for the first 2h of age while under parents’ care in the obstetrical center. Reliable and low-cost wireless monitoring that could be used immediately after delivery would promote widespread adoption of neonatal resuscitation recommendations in LMIC, improve detection of vital si
Conditions
Interventions
Group 1: Vaginal Delivery: Following normal, vaginal delivery, the wireless skin sensor monitoring system (Anne Arc & RAD7 Limb, Sibel Health Inc - Masimo) will be immediately placed on the newborn. T
Sponsors
The Research Institute of the McGill University Health Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Infants born by vaginal or C-Section delivery at any of the participating centers, with = 35 weeks gestational age and judged clinically stable immediately after birth
Exclusion criteria
Exclusion criteria: Skin abnormality that precludes sensors placement. Infants born at <35 weeks gestational age Clinically unstable infants born at = 35 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aim 1 – To determine the feasibility of using a wireless system immediately after delivery and for the first 2h of age, while in the obstetrical center under unsupervised parents’ care. The following outcomes will be measured for both wired and wireless systems: a. Percentage of time for which HR, RR, SpO2 and Tskin data are displayed. b. Occurrence of gaps in signal detection/recordings (% and length). c. Causes of the gaps in signal detection/recordings. d. Descriptive analysis of user surveys and their satisfaction with the wireless system. Aim 2 - To investigate the safety of using this wireless system immediately after delivery and for the first 2h of age. The following outcomes will be measured for both wired and wireless systems: a. Skin score to be determined by a blinded dermatologist using de-identified pictures of the skin after removal of the sensors of each system. b. Pain scale to assess any discomfort or pain during the removal of the sensors. c. Clinically significant events detected by the wired system (HR < 100 bpm or SpO2 < 80%) but missed by the wireless system. Aim 3 – To assess the accuracy of this wireless system in measuring HR, RR, SpO2 and Tskin signals compared with the “standard of care” wired system. The following outcomes will be computed: a. Correlation coefficient b. Slope c. Variance accounted for d. Bias | — |
Secondary
| Measure | Time frame |
|---|---|
| Further subgroup analyses will be conducted to assess for systematic differences in feasibility, safety, and accuracy of the wireless system between the following: · High vs. Low and Middle income countries · Female vs. Male subjects · Term vs. Preterm (born < 37 weeks gestational age) infants · C-section vs. Vaginal delivery · Skin pigmentation | — |
Countries
Brazil, Canada, Ireland, Italy, Mozambique, Switzerland, Zimbabwe
Contacts
Public ContactGuilherme Sant'Anna
The Research Institute of the McGill University Health Center
Outcome results
None listed