Advanced Wireless Sensors for Neonatal Care in the Delivery Room (AWARD)

Guilherme Sant'Anna, MD

Status: Enrolling

Conditions: Infant Death; Infant ALL; ECG Electrode Site Reaction; Newborn Asphyxia; Parents; Pregnancy Related; Sudden Unexplained Infant Death; Infant Conditions; Birth Asphyxia; Apnea of Newborn; Newborn; Vitality; Delivery Complication; Birth Outcome, Adverse; Newborn Morbidity; Delivery Problem for Fetus; Infant, Newborn, Diseases; Infant Apnea

Treatments: Device: Wired vital sign monitoring system; Device: Wireless skin sensors vital sign monitoring system

Study type: Interventional

Funder types: Other

Identifiers

NCT06693817

AWARD Study

Details and patient eligibility

About

The goals of this observational study is to assess whether a new advanced wireless skin sensor vital sign monitoring system can effectively monitor the vital signs of healthy newborn infants (≥ 35 weeks gestational age). The main aims of this Study are to:

1. Assess feasibility
2. Evaluate safety
3. Determine accuracy of the wireless monitoring system, compared to the standard of care wired vital sign monitoring system, immediately after delivery and for the first 2h of age in the obstetrical center under unsupervised parents' care. The newborn infants participating in the Study will have both vital sign monitoring systems placed on their chest and limb. Their vital signs will be monitored for 2h consecutively.

Full description

When the transition from intrauterine to extrauterine life necessitates Neonatal Resuscitation, specialized monitoring of vital signs is required. Sudden Unexpected Postnatal Collapse (SUPC) is an apnea or cardiorespiratory failure occurring in otherwise healthy near-term or term neonates, usually in the first 48 hours of age, during the initial Kangaroo Mother Care (KMC) in the obstetrical center. SUPC carries a high morbidity and mortality rate. Approximately 10 million babies do not breathe immediately after birth, and 60% require basic resuscitation interventions. Sudden Unexpected Postnatal Collapse has been estimated to occur in 2.6-133 cases per 100.000 newborns and over 50% of the cases occur following accidental suffocation, which frequently goes unrecognised by parents in the obstetrical center during unsupervised KMC.

Current guidelines recommend monitoring of heart rate (HR), oxygen saturation (SpO2), and skin temperature (Tskin) during neonatal resuscitation. This is usually achieved by using wired electrodes and sensors that require expensive and large base units attached to a power supply. SUPC is a rare but largely preventable cause of neonatal mortality that deserves particular attention. Better resuscitation and prevention of SUPC might be achieved by continuous non-intrusive monitoring of vital signs immediately after delivery and while in the obstetrical center.

This research will address a very important gap in care; the need for safe and accurate advanced, non-invasive, and non-intrusive wireless technologies for monitoring of vital signs immediately after birth and during the immediate postnatal care, potentially preventing cases of SUPC while 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 low and middle income countries, improve detection of vital signs quickly after delivery and during early unsupervised KMC, and optimize neonatal care in the obstetrical centers or during hospital stay, to prevent cases of SUPC and its associated high mortality.

Enrollment: 600 estimated patients

Sex: All

Ages: 35 to 42 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Newborns ≥35 weeks (gestational age)
2. Newborns determined to be clinically stable at delivery
3. Newborns with no skin abnormalities

Exclusion criteria

1. Newborns ≤ 35 weeks (gestational age)
2. Newborns determined to not be clinically stable at delivery
3. Newborns with Skin abnormalities

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Vaginal Birth

Other group

Description:

Wireless monitoring system placed first for vaginal birth. 15-20 minutes later, the wired monitoring system is placed. Both systems stay in place for 2 hours.

Treatment:

Device: Wireless skin sensors vital sign monitoring system

Device: Wired vital sign monitoring system

C-Section Birth

Other group

Description:

System placement randomized for C-section. One system placed first and the alternate placed immediately after. Both systems stay in place for 2 hours.

Treatment:

Device: Wireless skin sensors vital sign monitoring system

Device: Wired vital sign monitoring system